{ "FullStudy":{ "Rank":217746, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517373", "OrgStudyIdInfo":{ "OrgStudyId":"B1621002" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-005206-30", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Pfizer", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin", "OfficialTitle":"A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Glimepiride In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin" }, "StatusModule":{ "StatusVerifiedDate":"December 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"December 6, 2016", "ResultsFirstSubmitQCDate":"December 6, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 31, 2017", "ResultsFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"April 21, 2014", "DispFirstSubmitQCDate":"April 21, 2014", "DispFirstPostDateStruct":{ "DispFirstPostDate":"May 9, 2014", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 6, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 31, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Pfizer", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes Mellitus, Type 2" ] }, "KeywordList":{ "Keyword":[ "T2DM", "PF-04937319", "Phase 2" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"304", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo to match PF-04937319 and glimepiride", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"PF-04937319 10 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: PF-04937319 10 mg" ] } },{ "ArmGroupLabel":"PF-04937319 50 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: PF-04937319 50 mg" ] } },{ "ArmGroupLabel":"PF-04937319 100 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: PF-04937319 100 mg" ] } },{ "ArmGroupLabel":"Glimepiride", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Glimepiride" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"PF-04937319 10 mg", "InterventionDescription":"Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04937319 10 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"PF-04937319 50 mg", "InterventionDescription":"Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04937319 50 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"PF-04937319 100 mg", "InterventionDescription":"Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04937319 100 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Glimepiride", "InterventionDescription":"Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Glimepiride" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12", "PrimaryOutcomeDescription":"HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.", "PrimaryOutcomeTimeFrame":"Baseline (Day 1), Week 12" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8", "SecondaryOutcomeDescription":"HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.", "SecondaryOutcomeTimeFrame":"Baseline (Day 1), Week 2, 4, 6, 8" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12", "SecondaryOutcomeTimeFrame":"Baseline (Day 1), Week 2, 4, 6, 8, 12" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12", "SecondaryOutcomeDescription":"HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.", "SecondaryOutcomeTimeFrame":"Week 12" },{ "SecondaryOutcomeMeasure":"Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data", "SecondaryOutcomeDescription":"Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=200 then percent change of >50% counts]); QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >= 30 to <60 millisecond [msec], and change of >=60 msec).", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) up to Week 14" },{ "SecondaryOutcomeMeasure":"Number of Participants With Increase/Decrease From Baseline Vital Signs Data", "SecondaryOutcomeDescription":"Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion.", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) up to Week 14" },{ "SecondaryOutcomeMeasure":"Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)", "SecondaryOutcomeDescription":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode", "SecondaryOutcomeDescription":"A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) up to Week 14" },{ "SecondaryOutcomeMeasure":"Number of Hypoglycemic Events (HAE) Episodes Per Participant", "SecondaryOutcomeDescription":"A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) up to Week 14" },{ "SecondaryOutcomeMeasure":"Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant", "SecondaryOutcomeDescription":"Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) up to Week 14" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14", "SecondaryOutcomeTimeFrame":"Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)" },{ "SecondaryOutcomeMeasure":"Number of Participants With Abnormal Laboratory Values", "SecondaryOutcomeDescription":"Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) up to Week 14" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent\n\nExclusion Criteria:\n\nSubjects with recent cardiovascular events, those with evidence of diabetic complications", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Pfizer CT.gov Call Center", "OverallOfficialAffiliation":"Pfizer", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Sierra Clinical Research", "LocationCity":"Roseville", "LocationState":"California", "LocationZip":"95661", "LocationCountry":"United States" },{ "LocationFacility":"California Research Foundation", "LocationCity":"San Diego", "LocationState":"California", "LocationZip":"92103", "LocationCountry":"United States" },{ "LocationFacility":"Diablo Clinical Research, Inc.", "LocationCity":"Walnut Creek", "LocationState":"California", "LocationZip":"94598", "LocationCountry":"United States" },{ "LocationFacility":"Meridien Research", "LocationCity":"Bradenton", "LocationState":"Florida", "LocationZip":"34208", "LocationCountry":"United States" },{ "LocationFacility":"South Broward Research, LLC", "LocationCity":"Pembroke Pines", "LocationState":"Florida", "LocationZip":"33027", "LocationCountry":"United States" },{ "LocationFacility":"East-West Medical Research Institute", "LocationCity":"Honolulu", "LocationState":"Hawaii", "LocationZip":"96814", "LocationCountry":"United States" },{ "LocationFacility":"Clinical Research Center of Cape Cod, Inc.", "LocationCity":"Hyannis", "LocationState":"Massachusetts", "LocationZip":"02601", "LocationCountry":"United States" },{ "LocationFacility":"Diabetes & Endocrinology Consultants, PC", "LocationCity":"Morehead City", "LocationState":"North Carolina", "LocationZip":"28557", "LocationCountry":"United States" },{ "LocationFacility":"Sterling Research Group, Ltd.", "LocationCity":"Cincinnati", "LocationState":"Ohio", "LocationZip":"45246", "LocationCountry":"United States" },{ "LocationFacility":"Community Research", "LocationCity":"Cincinnati", "LocationState":"Ohio", "LocationZip":"45255", "LocationCountry":"United States" },{ "LocationFacility":"Coastal Carolina Research Center", "LocationCity":"Mount Pleasant", "LocationState":"South Carolina", "LocationZip":"29464", "LocationCountry":"United States" },{ "LocationFacility":"Holston Medical Group", "LocationCity":"Bristol", "LocationState":"Tennessee", "LocationZip":"37620", "LocationCountry":"United States" },{ "LocationFacility":"Chattanooga Medical Research, LLC", "LocationCity":"Chattanooga", "LocationState":"Tennessee", "LocationZip":"37404", "LocationCountry":"United States" },{ "LocationFacility":"Diagnostic Center", "LocationCity":"Chattanooga", "LocationState":"Tennessee", "LocationZip":"37404", "LocationCountry":"United States" },{ "LocationFacility":"University Diabetes and Endocrine Consultants", "LocationCity":"Chattanooga", "LocationState":"Tennessee", "LocationZip":"37411", "LocationCountry":"United States" },{ "LocationFacility":"Clinical Research Associates, Inc.", "LocationCity":"Nashville", "LocationState":"Tennessee", "LocationZip":"37203", "LocationCountry":"United States" },{ "LocationFacility":"Bristol Clinical Research, LLC", "LocationCity":"Austin", "LocationState":"Texas", "LocationZip":"78728", "LocationCountry":"United States" },{ "LocationFacility":"DiscoveResearch, Inc.", "LocationCity":"Bryan", "LocationState":"Texas", "LocationZip":"77802", "LocationCountry":"United States" },{ "LocationFacility":"Dallas Diabetes and Endocrine Center", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75230", "LocationCountry":"United States" },{ "LocationFacility":"Clinical Trials of Texas, Inc.", "LocationCity":"San Antonio", "LocationState":"Texas", "LocationZip":"78229", "LocationCountry":"United States" },{ "LocationFacility":"National Clinical Research - Norfolk, Inc.", "LocationCity":"Norfolk", "LocationState":"Virginia", "LocationZip":"23502", "LocationCountry":"United States" },{ "LocationFacility":"National Clinical Research - Richmond, Inc.", "LocationCity":"Richmond", "LocationState":"Virginia", "LocationZip":"23294", "LocationCountry":"United States" },{ "LocationFacility":"Aurora Advanced Healthcare, Inc.", "LocationCity":"Milwaukee", "LocationState":"Wisconsin", "LocationZip":"53209", "LocationCountry":"United States" },{ "LocationFacility":"MBAL Yulia Vrevska - Byala, Otdelenie po vatreshni bolesti", "LocationCity":"Byala", "LocationZip":"7100", "LocationCountry":"Bulgaria" },{ "LocationFacility":"MBAL - Ruse AD, Vtoro otdelenie po vatreshni bolesti", "LocationCity":"Ruse", "LocationZip":"7002", "LocationCountry":"Bulgaria" },{ "LocationFacility":"DKTs Akta Medika, Kabinet po endokrinologia", "LocationCity":"Sevlievo", "LocationZip":"5400", "LocationCountry":"Bulgaria" },{ "LocationFacility":"UMBAL Aleksandrovska, Klinika po endokrinologia i bolesti na obmyanata", "LocationCity":"Sofia", "LocationZip":"1431", "LocationCountry":"Bulgaria" },{ "LocationFacility":"VMA - MBAL - Sofia, Klinika po endokrinologia i bolesti na obmyanata", "LocationCity":"Sofia", "LocationZip":"1606", "LocationCountry":"Bulgaria" },{ "LocationFacility":"UMBAL Stara Zagora, Klinika po endokrinologia i bolesti na obmyanata", "LocationCity":"Stara Zagora", "LocationZip":"6003", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Glover Medical Clinic", "LocationCity":"Langley", "LocationState":"British Columbia", "LocationZip":"V3A 4H9", "LocationCountry":"Canada" },{ "LocationFacility":"Ocean West Research Clinic Inc.", "LocationCity":"Surrey", "LocationState":"British Columbia", "LocationZip":"V3S 2N6", "LocationCountry":"Canada" },{ "LocationFacility":"Rivergrove Medical Clinic", "LocationCity":"Winnipeg", "LocationState":"Manitoba", "LocationZip":"R2V 4W3", "LocationCountry":"Canada" },{ "LocationFacility":"Aggarwal and Associates Limited", "LocationCity":"Brampton", "LocationState":"Ontario", "LocationZip":"L6T 0G1", "LocationCountry":"Canada" },{ "LocationFacility":"DCTM CLinical Trials Group Ltd.", "LocationCity":"Strathroy", "LocationState":"Ontario", "LocationZip":"N7G 1Y7", "LocationCountry":"Canada" },{ "LocationFacility":"Manna Research", "LocationCity":"Toronto", "LocationState":"Ontario", "LocationZip":"M9W 4L6", "LocationCountry":"Canada" },{ "LocationFacility":"Pro-Recherche", "LocationCity":"St-Romuald", "LocationState":"Quebec", "LocationZip":"G6W 5M6", "LocationCountry":"Canada" },{ "LocationFacility":"Centre de cardiologie et de Recherche Clinique Pierre-Le Gardeur", "LocationCity":"Terrebonne", "LocationState":"Quebec", "LocationZip":"J6V 1S8", "LocationCountry":"Canada" },{ "LocationFacility":"Alpha Recherche Clinique", "LocationCity":"Quebec", "LocationZip":"G3K 2P8", "LocationCountry":"Canada" },{ "LocationFacility":"Dr. Kenessey Albert Korhaz-Rendelointezet/Belgyogyaszat", "LocationCity":"Balassagyarmat", "LocationZip":"2660", "LocationCountry":"Hungary" },{ "LocationFacility":"Synexus Magyarorszag Kft.", "LocationCity":"Budapest", "LocationZip":"1036", "LocationCountry":"Hungary" },{ "LocationFacility":"Semmelweis Egyetem/I. sz. Belgyogyaszati Klinika", "LocationCity":"Budapest", "LocationZip":"1083", "LocationCountry":"Hungary" },{ "LocationFacility":"Fejer Megyei Szent Gyorgy Korhaz/II. Belgyogyaszati Osztaly", "LocationCity":"Szekesfehervar", "LocationZip":"8000", "LocationCountry":"Hungary" },{ "LocationFacility":"BGS Global Hospital", "LocationCity":"Bangalore", "LocationState":"Karnataka", "LocationZip":"560060", "LocationCountry":"India" },{ "LocationFacility":"Deenanath Mangeshkar Hospital & Research Centre", "LocationCity":"Pune", "LocationState":"Maharashtra", "LocationZip":"411 004", "LocationCountry":"India" },{ "LocationFacility":"Diabetes Unit, K.E.M. Hospital Research Centre", "LocationCity":"Pune", "LocationState":"Maharashtra", "LocationZip":"411 011", "LocationCountry":"India" },{ "LocationFacility":"Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica", "LocationCity":"Banska Bystrica", "LocationZip":"975 17", "LocationCountry":"Slovakia" },{ "LocationFacility":"Interna A Diabetologicka Ambulancia", "LocationCity":"Moldava Nad Bodvou", "LocationZip":"045 01", "LocationCountry":"Slovakia" },{ "LocationFacility":"FUNKYSTUFF, s.r.o.", "LocationCity":"Nove Zamky", "LocationZip":"940 01", "LocationCountry":"Slovakia" },{ "LocationFacility":"MEDIAB, s.r.o.", "LocationCity":"Pezinok", "LocationZip":"902 01", "LocationCountry":"Slovakia" },{ "LocationFacility":"MEDIVASA, s.r.o.", "LocationCity":"Zilina", "LocationZip":"010 01", "LocationCountry":"Slovakia" },{ "LocationFacility":"China Medical University Hospital", "LocationCity":"Taichung", "LocationZip":"404", "LocationCountry":"Taiwan" },{ "LocationFacility":"National Taiwan University Hospital", "LocationCity":"Taipei", "LocationZip":"100", "LocationCountry":"Taiwan" },{ "LocationFacility":"Taipei Medical University Hospital", "LocationCity":"Taipei", "LocationZip":"110", "LocationCountry":"Taiwan" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25885172", "ReferenceType":"derived", "ReferenceCitation":"Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"To obtain contact information for a study center near you, click here.", "SeeAlsoLinkURL":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1621002&StudyName=Study%20To%20Understand%20Efficacy%20And%20Safety%20Of%20Investigational%20Agent%20%28PF-04937319%29%20Compared%20To%20Approved%20Agent%20%28Glimepiride%29%20In%20Patients%20" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"A total of 628 participants were consented. Of these, 361 participants transitioned to the run-in period and received sponsor provided background therapy of Metformin. Participants completed the run-in period were then randomized to receive either placebo, PF-04937319 (10, 50 or 100 milligram [mg]) or Glimepiride in treatment period.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Metformin 500 mg", "FlowGroupDescription":"Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"PF-04937319 10 mg", "FlowGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"PF-04937319 50 mg", "FlowGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "FlowGroupId":"FG004", "FlowGroupTitle":"PF-04937319 100 mg", "FlowGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "FlowGroupId":"FG005", "FlowGroupTitle":"Glimepiride", "FlowGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Run-in Period", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"361" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"304" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"57" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Did not meet eligibility criteria", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"34" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"12" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Sponsor Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Treatment Period", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"61" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"60" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"61" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"61" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"61" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"57" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"54" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"54" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"55" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"54" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"7" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Medication error without AEs", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"2" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Baseline analysis population included all randomized participants who received at least 1 dose of study treatment.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"PF-04937319 10 mg", "BaselineGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"PF-04937319 50 mg", "BaselineGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"PF-04937319 100 mg", "BaselineGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Glimepiride", "BaselineGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "BaselineGroupId":"BG005", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"61" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"60" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"61" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"61" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"61" },{ "BaselineDenomCountGroupId":"BG005", "BaselineDenomCountValue":"304" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":">=18 to =<44 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"38" } ] } } ] } },{ "BaselineClassTitle":">=45 to =<64 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"45" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"48" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"40" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"35" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"48" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"216" } ] } } ] } },{ "BaselineClassTitle":">64 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"50" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Gender", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"24" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"32" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"22" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"131" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"34" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"34" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"37" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"39" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"173" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12", "OutcomeMeasureDescription":"HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"percentage of hemoglobin", "OutcomeMeasureTimeFrame":"Baseline (Day 1), Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"59" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"57" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=59, 57, 55, 60, 60)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.90", "OutcomeMeasurementSpread":"0.988" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.97", "OutcomeMeasurementSpread":"0.886" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7.91", "OutcomeMeasurementSpread":"0.987" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7.88", "OutcomeMeasurementSpread":"0.969" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"8.12", "OutcomeMeasurementSpread":"0.884" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 12 (n=56, 53, 53, 54, 54)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.13", "OutcomeMeasurementSpread":"0.789" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.18", "OutcomeMeasurementSpread":"0.804" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.45", "OutcomeMeasurementSpread":"0.733" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.64", "OutcomeMeasurementSpread":"0.797" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-1.01", "OutcomeMeasurementSpread":"0.709" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment,duration of type 2 diabetes mellitus (T2DM),time and treatment-by-time interaction as fixed effects,baseline as the covariate,time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.4468", "OutcomeAnalysisPValueComment":"p-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisStatisticalComment":"No adjustments were made for multiple comparisons among treatment groups.", "OutcomeAnalysisParamType":"Least Squares (LS) Mean Difference", "OutcomeAnalysisParamValue":"-0.02", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.21", "OutcomeAnalysisCIUpperLimit":"0.17", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.145" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0218", "OutcomeAnalysisPValueComment":"p-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisStatisticalComment":"No adjustments were made for multiple comparisons among treatment groups.", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.30", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.48", "OutcomeAnalysisCIUpperLimit":"-0.11", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.146" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0006", "OutcomeAnalysisPValueComment":"p-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisStatisticalComment":"No adjustments were made for multiple comparisons among treatment groups.", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.47", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.65", "OutcomeAnalysisCIUpperLimit":"-0.28", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.144" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"p-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisStatisticalComment":"No adjustments were made for multiple comparisons among treatment groups.", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.83", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-1.02", "OutcomeAnalysisCIUpperLimit":"-0.65", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.144" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8", "OutcomeMeasureDescription":"HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.", "OutcomeMeasurePopulationDescription":"FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"percentage of hemoglobin", "OutcomeMeasureTimeFrame":"Baseline (Day 1), Week 2, 4, 6, 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"58" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"57" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"58" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 4 (n=58, 57, 55, 58, 60)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.08", "OutcomeMeasurementSpread":"0.590" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.07", "OutcomeMeasurementSpread":"0.422" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.22", "OutcomeMeasurementSpread":"0.431" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.32", "OutcomeMeasurementSpread":"0.532" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-0.54", "OutcomeMeasurementSpread":"0.379" } ] } } ] } },{ "OutcomeClassTitle":"Week 6 (n=57, 55, 55, 58, 55)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.14", "OutcomeMeasurementSpread":"0.676" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.14", "OutcomeMeasurementSpread":"0.545" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.22", "OutcomeMeasurementSpread":"0.494" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.51", "OutcomeMeasurementSpread":"0.479" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-0.78", "OutcomeMeasurementSpread":"0.500" } ] } } ] } },{ "OutcomeClassTitle":"Week 8 (n=58, 55, 53, 57, 55)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.19", "OutcomeMeasurementSpread":"0.756" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.17", "OutcomeMeasurementSpread":"0.628" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.38", "OutcomeMeasurementSpread":"0.575" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.59", "OutcomeMeasurementSpread":"0.571" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-0.89", "OutcomeMeasurementSpread":"0.582" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.6112", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.02", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.09", "OutcomeAnalysisCIUpperLimit":"0.14", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.087" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0550", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.14", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.25", "OutcomeAnalysisCIUpperLimit":"-0.03", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.088" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80%CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0032", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.24", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.35", "OutcomeAnalysisCIUpperLimit":"-0.13", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.086" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.44", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.55", "OutcomeAnalysisCIUpperLimit":"-0.33", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.086" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.6146", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.03", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.10", "OutcomeAnalysisCIUpperLimit":"0.16", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.101" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.2606", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.07", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.19", "OutcomeAnalysisCIUpperLimit":"0.06", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.101" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0006", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.32", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.45", "OutcomeAnalysisCIUpperLimit":"-0.20", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.099" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.57", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.70", "OutcomeAnalysisCIUpperLimit":"-0.44", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.100" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.6618", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.05", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.10", "OutcomeAnalysisCIUpperLimit":"0.20", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.118" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0878", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.16", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.31", "OutcomeAnalysisCIUpperLimit":"-0.01", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.119" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0022", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.34", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.49", "OutcomeAnalysisCIUpperLimit":"-0.19", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.117" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.66", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.81", "OutcomeAnalysisCIUpperLimit":"-0.51", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.117" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"milligram per deciliter (mg/dL)", "OutcomeMeasureTimeFrame":"Baseline (Day 1), Week 2, 4, 6, 8, 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"59" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"61" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=60, 59, 60, 61, 61)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"161.3", "OutcomeMeasurementSpread":"30.74" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"168.7", "OutcomeMeasurementSpread":"43.01" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"174.7", "OutcomeMeasurementSpread":"36.43" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"160.4", "OutcomeMeasurementSpread":"37.03" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"163.7", "OutcomeMeasurementSpread":"35.99" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 2 (n=60, 59, 60, 61, 59)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.1", "OutcomeMeasurementSpread":"23.89" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.0", "OutcomeMeasurementSpread":"46.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-7.9", "OutcomeMeasurementSpread":"29.29" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-10.5", "OutcomeMeasurementSpread":"20.83" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-19.9", "OutcomeMeasurementSpread":"25.68" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 4 (n=59, 58, 56, 59, 60)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.5", "OutcomeMeasurementSpread":"27.66" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-8.4", "OutcomeMeasurementSpread":"41.99" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-7.7", "OutcomeMeasurementSpread":"27.49" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-11.4", "OutcomeMeasurementSpread":"22.84" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-26.2", "OutcomeMeasurementSpread":"31.00" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 6 (n=58, 56, 56, 59, 57)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.6", "OutcomeMeasurementSpread":"31.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-6.9", "OutcomeMeasurementSpread":"41.80" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-7.2", "OutcomeMeasurementSpread":"24.63" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-10.4", "OutcomeMeasurementSpread":"28.48" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-23.4", "OutcomeMeasurementSpread":"35.01" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 8 (n=59, 56, 54, 58, 57)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.9", "OutcomeMeasurementSpread":"29.70" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-7.0", "OutcomeMeasurementSpread":"43.93" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-13.0", "OutcomeMeasurementSpread":"27.48" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-13.0", "OutcomeMeasurementSpread":"23.07" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-26.9", "OutcomeMeasurementSpread":"32.08" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 12 (n=57, 54, 54, 55, 55)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.4", "OutcomeMeasurementSpread":"31.29" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-6.2", "OutcomeMeasurementSpread":"45.22" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-9.9", "OutcomeMeasurementSpread":"37.09" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-10.3", "OutcomeMeasurementSpread":"34.69" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-22.5", "OutcomeMeasurementSpread":"30.86" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.3446", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-2.09", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-8.80", "OutcomeAnalysisCIUpperLimit":"4.62", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.222" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1204", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-6.12", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-12.81", "OutcomeAnalysisCIUpperLimit":"0.57", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.210" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0041", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-13.74", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-20.37", "OutcomeAnalysisCIUpperLimit":"-7.10", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.166" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-21.34", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-28.01", "OutcomeAnalysisCIUpperLimit":"-14.67", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.192" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1616", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-5.14", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-11.80", "OutcomeAnalysisCIUpperLimit":"1.53", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.191" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1974", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-4.45", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-11.15", "OutcomeAnalysisCIUpperLimit":"2.26", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.219" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0122", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-11.62", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-18.22", "OutcomeAnalysisCIUpperLimit":"-5.02", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.140" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-24.79", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-31.37", "OutcomeAnalysisCIUpperLimit":"-18.20", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.129" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.3645", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-1.97", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-9.26", "OutcomeAnalysisCIUpperLimit":"5.32", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.674" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.3672", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-1.93", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-9.22", "OutcomeAnalysisCIUpperLimit":"5.36", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.676" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0906", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-7.50", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-14.69", "OutcomeAnalysisCIUpperLimit":"-0.31", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.598" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0003", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-19.69", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-26.91", "OutcomeAnalysisCIUpperLimit":"-12.46", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.624" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1748", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-5.18", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-12.29", "OutcomeAnalysisCIUpperLimit":"1.93", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.534" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0297", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-10.54", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-17.69", "OutcomeAnalysisCIUpperLimit":"-3.38", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.566" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0118", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-12.44", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-19.47", "OutcomeAnalysisCIUpperLimit":"-5.41", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.469" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-27.00", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-34.04", "OutcomeAnalysisCIUpperLimit":"-19.96", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.480" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1012", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-8.03", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-16.10", "OutcomeAnalysisCIUpperLimit":"0.04", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"6.281" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0409", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-10.99", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-19.07", "OutcomeAnalysisCIUpperLimit":"-2.91", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"6.287" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0089", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-14.87", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-22.88", "OutcomeAnalysisCIUpperLimit":"-6.86", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"6.232" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 1-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 1 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-25.93", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-33.93", "OutcomeAnalysisCIUpperLimit":"-17.92", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"6.233" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12", "OutcomeMeasureDescription":"HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"57" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"54" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"54" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"55" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Less Than 6.5 Percent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"18.5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"27.3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"18.2" } ] } } ] } },{ "OutcomeClassTitle":"Less Than 7 Percent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"26.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"31.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"27.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"52.7" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"45.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data", "OutcomeMeasureDescription":"Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=200 then percent change of >50% counts]); QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >= 30 to <60 millisecond [msec], and change of >=60 msec).", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment. N(number of participants analyzed)= participants who were evaluable for this measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline (Day 1) up to Week 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"59" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"59" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"61" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"PR interval: Percent change of >=25/50%", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"QRS interval: Percent change of >=50%", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"QTcF interval: Change of >=30 to <60 msec", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"QTcF interval: Change of >=60 msec", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Increase/Decrease From Baseline Vital Signs Data", "OutcomeMeasureDescription":"Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline (Day 1) up to Week 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"61" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Increase in systolic BP (>=30 mmHg)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Increase in diastolic BP (>=20 mmHg)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Decrease in systolic BP (>=30 mmHg)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Decrease in diastolic BP (>=20 mmHg)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)", "OutcomeMeasureDescription":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"61" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"AEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"31" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"29" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"36" } ] } } ] } },{ "OutcomeClassTitle":"SAEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode", "OutcomeMeasureDescription":"A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Baseline (Day 1) up to Week 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"61" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"34.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Hypoglycemic Events (HAE) Episodes Per Participant", "OutcomeMeasureDescription":"A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"events per participant", "OutcomeMeasureTimeFrame":"Baseline (Day 1) up to Week 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"61" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"9" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"65" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant", "OutcomeMeasureDescription":"Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.", "OutcomeMeasurePopulationDescription":"Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"Baseline (Day 1) up to Week 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"kilogram (kg)", "OutcomeMeasureTimeFrame":"Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"59" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"57" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"58" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=59, 57, 58, 61, 60)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"89.859", "OutcomeMeasurementSpread":"21.9513" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"89.518", "OutcomeMeasurementSpread":"20.5752" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"89.860", "OutcomeMeasurementSpread":"21.4376" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"87.530", "OutcomeMeasurementSpread":"19.2248" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"90.388", "OutcomeMeasurementSpread":"17.9358" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 2 (n=59, 57, 58, 61, 58)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.402", "OutcomeMeasurementSpread":"1.0127" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.069", "OutcomeMeasurementSpread":"1.1309" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.028", "OutcomeMeasurementSpread":"1.0557" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.021", "OutcomeMeasurementSpread":"0.9504" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-0.024", "OutcomeMeasurementSpread":"1.1295" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 4 (n=58, 56, 55, 59, 60)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.620", "OutcomeMeasurementSpread":"1.2025" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.378", "OutcomeMeasurementSpread":"1.2415" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.074", "OutcomeMeasurementSpread":"1.2356" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.284", "OutcomeMeasurementSpread":"1.2856" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0.310", "OutcomeMeasurementSpread":"1.3831" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 6 (n=57, 54, 55, 59, 56)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.564", "OutcomeMeasurementSpread":"1.3880" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.604", "OutcomeMeasurementSpread":"1.3153" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.228", "OutcomeMeasurementSpread":"1.6697" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.290", "OutcomeMeasurementSpread":"1.2669" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0.473", "OutcomeMeasurementSpread":"1.4922" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 8 (n=58, 54, 53, 58, 56)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.082", "OutcomeMeasurementSpread":"1.7217" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.522", "OutcomeMeasurementSpread":"1.5396" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.311", "OutcomeMeasurementSpread":"2.2260" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.397", "OutcomeMeasurementSpread":"1.1285" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0.493", "OutcomeMeasurementSpread":"1.7023" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 12 (n=56, 52, 53, 55, 54)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.529", "OutcomeMeasurementSpread":"2.0906" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.685", "OutcomeMeasurementSpread":"1.7244" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.961", "OutcomeMeasurementSpread":"2.6114" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.545", "OutcomeMeasurementSpread":"1.4004" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1.211", "OutcomeMeasurementSpread":"1.8771" } ] } } ] } },{ "OutcomeClassTitle":"Change at Week 14 (n=55, 51, 53, 55, 53)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.478", "OutcomeMeasurementSpread":"2.0389" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.472", "OutcomeMeasurementSpread":"2.0387" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.978", "OutcomeMeasurementSpread":"2.7040" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.573", "OutcomeMeasurementSpread":"1.6589" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1.234", "OutcomeMeasurementSpread":"1.7481" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, duration of type 2 diabetes mellitus (T2DM), time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0898", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.33", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.08", "OutcomeAnalysisCIUpperLimit":"0.59", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.196" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0555", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.37", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.12", "OutcomeAnalysisCIUpperLimit":"0.62", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.195" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0585", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.37", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.12", "OutcomeAnalysisCIUpperLimit":"0.61", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.193" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0454", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.39", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.14", "OutcomeAnalysisCIUpperLimit":"0.64", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.194" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.2819", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.25", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.05", "OutcomeAnalysisCIUpperLimit":"0.55", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.235" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0319", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.51", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.20", "OutcomeAnalysisCIUpperLimit":"0.81", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.235" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1835", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.31", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.01", "OutcomeAnalysisCIUpperLimit":"0.60", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.231" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0001", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.93", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.63", "OutcomeAnalysisCIUpperLimit":"1.22", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.231" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.9689", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"-0.01", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.35", "OutcomeAnalysisCIUpperLimit":"0.33", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.266" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.2221", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.32", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.02", "OutcomeAnalysisCIUpperLimit":"0.67", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.265" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.2774", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.28", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.05", "OutcomeAnalysisCIUpperLimit":"0.62", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.261" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"1.09", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.76", "OutcomeAnalysisCIUpperLimit":"1.43", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.263" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0667", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.58", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.17", "OutcomeAnalysisCIUpperLimit":"0.98", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.314" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0133", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.78", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.38", "OutcomeAnalysisCIUpperLimit":"1.19", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.314" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0260", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.69", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.29", "OutcomeAnalysisCIUpperLimit":"1.08", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.308" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"1.63", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.23", "OutcomeAnalysisCIUpperLimit":"2.02", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.310" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0335", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.80", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.32", "OutcomeAnalysisCIUpperLimit":"1.28", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.374" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1557", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.53", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.05", "OutcomeAnalysisCIUpperLimit":"1.01", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.373" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0132", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.92", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.45", "OutcomeAnalysisCIUpperLimit":"1.39", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.368" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"2.68", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"2.20", "OutcomeAnalysisCIUpperLimit":"3.15", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.370" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0158", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.96", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.45", "OutcomeAnalysisCIUpperLimit":"1.46", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.394" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.2132", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.49", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.01", "OutcomeAnalysisCIUpperLimit":"0.99", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.392" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0263", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.86", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.37", "OutcomeAnalysisCIUpperLimit":"1.36", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.387" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG004" ] }, "OutcomeAnalysisGroupDescription":"Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"P-value was 2-sided.", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"2.62", "OutcomeAnalysisCIPctValue":"80", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"2.12", "OutcomeAnalysisCIUpperLimit":"3.12", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.390" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Abnormal Laboratory Values", "OutcomeMeasureDescription":"Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline (Day 1) up to Week 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04937319 10 mg", "OutcomeGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PF-04937319 50 mg", "OutcomeGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"PF-04937319 100 mg", "OutcomeGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Glimepiride", "OutcomeGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"60" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"61" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"56" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"52" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"56" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"54" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"51" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsDescription":"Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. AEs were also collected during the course of run-in period (metformin background therapy).", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Metformin 500 mg", "EventGroupDescription":"Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.", "EventGroupSeriousNumAffected":"4", "EventGroupSeriousNumAtRisk":"361", "EventGroupOtherNumAffected":"63", "EventGroupOtherNumAtRisk":"361" },{ "EventGroupId":"EG001", "EventGroupTitle":"Placebo", "EventGroupDescription":"Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"61", "EventGroupOtherNumAffected":"26", "EventGroupOtherNumAtRisk":"61" },{ "EventGroupId":"EG002", "EventGroupTitle":"PF-04937319 10 mg", "EventGroupDescription":"PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"60", "EventGroupOtherNumAffected":"28", "EventGroupOtherNumAtRisk":"60" },{ "EventGroupId":"EG003", "EventGroupTitle":"PF-04937319 50 mg", "EventGroupDescription":"PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"61", "EventGroupOtherNumAffected":"31", "EventGroupOtherNumAtRisk":"61" },{ "EventGroupId":"EG004", "EventGroupTitle":"PF-04937319 100 mg", "EventGroupDescription":"PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"61", "EventGroupOtherNumAffected":"29", "EventGroupOtherNumAtRisk":"61" },{ "EventGroupId":"EG005", "EventGroupTitle":"Glimepiride", "EventGroupDescription":"Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"61", "EventGroupOtherNumAffected":"36", "EventGroupOtherNumAtRisk":"61" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Aortic valve incompetence", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Cardiac failure congestive", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Death", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Cellulitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Pneumonia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Sepsis syndrome", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Ankle fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Dehydration", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Hyperglycaemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Pain in extremity", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Presyncope", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Alcohol abuse", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Chronic obstructive pulmonary disease", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Aortic aneurysm", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } },{ "SeriousEventTerm":"Deep vein thrombosis", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"361" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"61" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Anaemia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"361" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"60" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"61" } ] } },{ "OtherEventTerm":"Leukocytosis", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"361" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"60" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"61" } ] } },{ "OtherEventTerm":"Leukopenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"361" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", 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