{ "FullStudy":{ "Rank":218081, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512979", "OrgStudyIdInfo":{ "OrgStudyId":"1218.83" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-004158-24", "SecondaryIdType":"EudraCT Number", "SecondaryIdDomain":"EudraCT" } ] }, "Organization":{ "OrgFullName":"Boehringer Ingelheim", "OrgClass":"INDUSTRY" }, "BriefTitle":"Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes", "OfficialTitle":"A 24-week, Randomized, Double-blind, Active-controlled, Parallel Group Trial to Assess the Superiority of Oral Linagliptin and Metformin Compared to Linagliptin Monotherapy in Newly Diagnosed, Treatment-naïve, Uncontrolled Type 2 Diabetes Mellitus Patients" }, "StatusModule":{ "StatusVerifiedDate":"May 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"April 8, 2014", "ResultsFirstSubmitQCDate":"April 8, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 9, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 12, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 20, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Boehringer Ingelheim", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Eli Lilly and Company", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes Mellitus, Type 2" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double" } }, "EnrollmentInfo":{ "EnrollmentCount":"316", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"linagliptin", "ArmGroupType":"Experimental", "ArmGroupDescription":"patients receive linagliptin tablet once daily", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: linagliptin", "Drug: metformin placebo" ] } },{ "ArmGroupLabel":"linagliptin plus metformin", "ArmGroupType":"Experimental", "ArmGroupDescription":"patients receive linagliptin tablet once daily and metformin tablets twice daily", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: metformin", "Drug: linagliptin", "Drug: metformin placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"metformin", "InterventionDescription":"1000 mg to 2000 mg per day", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "linagliptin plus metformin" ] } },{ "InterventionType":"Drug", "InterventionName":"linagliptin", "InterventionDescription":"5 mg daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "linagliptin", "linagliptin plus metformin" ] } },{ "InterventionType":"Drug", "InterventionName":"metformin placebo", "InterventionDescription":"0 to 2 tablets daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "linagliptin plus metformin" ] } },{ "InterventionType":"Drug", "InterventionName":"metformin placebo", "InterventionDescription":"4 tablets daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "linagliptin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in HbA1c After 24 Weeks", "PrimaryOutcomeDescription":"HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c", "PrimaryOutcomeTimeFrame":"Baseline and 24 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment", "SecondaryOutcomeDescription":"The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.", "SecondaryOutcomeTimeFrame":"Baseline and 24 weeks" },{ "SecondaryOutcomeMeasure":"Change From Baseline in HbA1c by Visit Over Time", "SecondaryOutcomeDescription":"HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.", "SecondaryOutcomeTimeFrame":"Baseline, 6, 12, 18 and 24 weeks" },{ "SecondaryOutcomeMeasure":"Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)", "SecondaryOutcomeDescription":"The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.", "SecondaryOutcomeTimeFrame":"Baseline and 24 weeks" },{ "SecondaryOutcomeMeasure":"Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)", "SecondaryOutcomeDescription":"The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.", "SecondaryOutcomeTimeFrame":"Baseline and 24 weeks" },{ "SecondaryOutcomeMeasure":"Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment", "SecondaryOutcomeDescription":"The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.", "SecondaryOutcomeTimeFrame":"Baseline and 24 weeks" },{ "SecondaryOutcomeMeasure":"Change From Baseline in FPG by Visit Over Time", "SecondaryOutcomeDescription":"The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.", "SecondaryOutcomeTimeFrame":"Baseline, 6, 12, 18 and 24 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion criteria:\n\nPatients must sign and date an Informed Consent consistent with International Conference on Harmonisation / Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial.\nMale and female patients, 18 years of age or older at Visit 1 (Screen), with newly diagnosed (less than 12 months prior to Screen) Type 2 Diabetes Mellitus.\nPatients who are treatment-naïve, defined as absence of any oral antidiabetic therapy, injectable glucagon-like peptide-1 agonist/analogue, or insulin, and uncontrolled for the 12 weeks prior to randomisation.\nPatients must have an glycated (or glycosylated) haemoglobin (HbA1c) between 8.5% [69 millimoles per mole (mmol/mol)] and 12.0% (108 mmol/mol) at Visit 1 (Screen).\nPatients must have a Body Mass Index (BMI) of 45 kg/m2 or less at Visit 1 (Screen).\nIn the investigators opinion, patients must be reliable, honest, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.\n\nExclusion criteria:\n\nPatients with, who are, who have, or who have had:\n\nAcute coronary syndrome (non-ST Elevation Myocardial Infarction (STEMI), STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent.\nIndication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal (ULN) in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase. Gilbert-Meulengracht syndrome (also known as conjugated hyperbilirubinemia, constitutional hepatic dysfunction, or familial nonhemolytic jaundice) will be permitted.\nImpaired renal function, defined as calculated creatinine clearance of less than 60 milliliters per minute (< 60 mL/min), by the Cockcroft-Gault Equation, as determined during Screen and/or Run-In Period.\nBariatric, gastric bypass, and other gastrointestinal surgeries (including all types of gastric banding and/or LapBand) within the past two years.\nMedical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.\nMedical history of pancreatitis.\nBlood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, haemolytic anaemia).\nAny contraindication to metformin and/or linagliptin therapies, according to local labels.\nTreatment with anti-obesity drugs, including over-the-counter drugs such as Alli (orlistat), 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight.\nCurrent treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Type 2 Diabetes Mellitus.\n\nPre-menopausal women (last menstruation of 1 year or less prior to informed consent) who are nursing or pregnant, are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial and do not agree to submit to periodic pregnancy testing during participation in the trial.\n\nNote: Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable, intra-vaginal, or injectable contraceptives, Essure micro-inserts placed more than six months prior to Screen Visit, complete sexual abstinence (if acceptable by local authorities), double barrier method (e.g., diaphragm or condom and spermicide), and vasectomised partner.\n\nAlcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance to trial procedures or study medication intake in the opinion of the investigator.\nParticipation in another trial with an investigational drug within 2 months prior to informed consent.\nAny other clinical condition that would jeopardize patient safety while participating in this clinical trial in the opinion of the Investigator.\nInability to commit to regular overnight fasting of at least 10 hours duration and attendance to study site visits between 07:00 and 11:00 ante meridiem (a.m.).", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ 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"LocationCity":"Perak", "LocationCountry":"Malaysia" },{ "LocationFacility":"1218.83.60003 Boehringer Ingelheim Investigational Site", "LocationCity":"Selangor, Malaysia", "LocationCountry":"Malaysia" },{ "LocationFacility":"1218.83.52004 Boehringer Ingelheim Investigational Site", "LocationCity":"Cuautla", "LocationCountry":"Mexico" },{ "LocationFacility":"1218.83.52001 Boehringer Ingelheim Investigational Site", "LocationCity":"Guadalajara", "LocationCountry":"Mexico" },{ "LocationFacility":"1218.83.52002 Boehringer Ingelheim Investigational Site", "LocationCity":"Guadalajara", "LocationCountry":"Mexico" },{ "LocationFacility":"1218.83.52005 Boehringer Ingelheim Investigational Site", "LocationCity":"Merida", "LocationCountry":"Mexico" },{ "LocationFacility":"1218.83.52003 Boehringer Ingelheim Investigational Site", "LocationCity":"Tampico", "LocationCountry":"Mexico" },{ "LocationFacility":"1218.83.63007 Boehringer Ingelheim Investigational Site", "LocationCity":"Cebu City", 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Site", "LocationCity":"Muang, Khonkaen", "LocationCountry":"Thailand" },{ "LocationFacility":"1218.83.38007 Boehringer Ingelheim Investigational Site", "LocationCity":"Dnepropetrovsk", "LocationCountry":"Ukraine" },{ "LocationFacility":"1218.83.38001 Boehringer Ingelheim Investigational Site", "LocationCity":"Ivano-Frankivsk", "LocationCountry":"Ukraine" },{ "LocationFacility":"1218.83.38006 Boehringer Ingelheim Investigational Site", "LocationCity":"Kharkiv", "LocationCountry":"Ukraine" },{ "LocationFacility":"1218.83.38004 Boehringer Ingelheim Investigational Site", "LocationCity":"Odessa", "LocationCountry":"Ukraine" },{ "LocationFacility":"1218.83.38008 Boehringer Ingelheim Investigational Site", "LocationCity":"Vinnitsa", "LocationCountry":"Ukraine" },{ "LocationFacility":"1218.83.38003 Boehringer Ingelheim Investigational Site", "LocationCity":"Vinnytsya", "LocationCountry":"Ukraine" },{ "LocationFacility":"1218.83.38005 Boehringer Ingelheim Investigational Site", "LocationCity":"Vinnytsya", "LocationCountry":"Ukraine" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"27684308", "ReferenceType":"derived", "ReferenceCitation":"Ross SA, Caballero AE, Del Prato S, Gallwitz B, Lewis-D'Agostino D, Bailes Z, Thiemann S, Patel S, Woerle HJ, von Eynatten M. Linagliptin plus metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycemia. Postgrad Med. 2016 Nov;128(8):747-754. Epub 2016 Sep 29." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Linagliptin 5mg + Metformin", "FlowGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Linagliptin 5mg", "FlowGroupDescription":"Patients treated with linagliptin 5mg" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Randomised and treated", "FlowAchievementNumSubjects":"159" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Randomised and treated", "FlowAchievementNumSubjects":"157" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"140" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"135" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"19" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"22" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Reason other than stated above", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"13" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"9" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Patients from Treated Set (TS): All patients treated with at least 1 dose of study drug.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Linagliptin 5mg + Metformin", "BaselineGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Linagliptin 5mg", "BaselineGroupDescription":"Patients treated with linagliptin 5mg" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"159" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"157" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"316" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"49.0", "BaselineMeasurementSpread":"10.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"48.6", "BaselineMeasurementSpread":"11.2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"48.8", "BaselineMeasurementSpread":"11.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"90" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"80" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"170" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"69" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"77" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"146" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Baseline HbA1c", "BaselineMeasureDescription":"Baseline HbA1c was analyzed for the Full Analysis Set which includes all patients randomised, treated with at least 1 dose of study drug, with a baseline HbA1c value and at least 1 on-treatment HbA1c value. The Linagliptin 5mg + Metformin group includes 153 participants, the Linagliptin 5mg group includes 150 participants (303 participants in total).", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"percentage", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9.79", "BaselineMeasurementSpread":"1.19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9.88", "BaselineMeasurementSpread":"1.10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9.83", "BaselineMeasurementSpread":"1.14" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in HbA1c After 24 Weeks", "OutcomeMeasureDescription":"HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c", "OutcomeMeasurePopulationDescription":"Per Protocol completers cohort (PPCC): All patients randomised, treated with at least 1 dose of study drug, with a baseline HbA1c value without important protocol violations and who completed 24 weeks of treatment, were not treated with rescue medication and have an HbA1c measurement after 24 weeks of treatment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent", "OutcomeMeasureTimeFrame":"Baseline and 24 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Linagliptin 5mg + Metformin", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Linagliptin 5mg", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"132" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"113" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.81", "OutcomeMeasurementSpread":"0.12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.02", "OutcomeMeasurementSpread":"0.13" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"The model includes treatment and continuous baseline HbA1c.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.79", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-1.13", "OutcomeAnalysisCIUpperLimit":"-0.46", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.17" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment", "OutcomeMeasureDescription":"The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.", "OutcomeMeasurePopulationDescription":"Patients from PPCC (LOCF)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mg/dL", "OutcomeMeasureTimeFrame":"Baseline and 24 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Linagliptin 5mg + Metformin", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Linagliptin 5mg", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"132" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"113" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-47.1", "OutcomeMeasurementSpread":"3.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-30.2", "OutcomeMeasurementSpread":"4.2" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0032", "OutcomeAnalysisPValueComment":"The model includes treatment, continuous baseline HbA1c and continuous baseline FPG.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-16.9", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-28.0", "OutcomeAnalysisCIUpperLimit":"-5.7", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"5.7" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in HbA1c by Visit Over Time", "OutcomeMeasureDescription":"HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.", "OutcomeMeasurePopulationDescription":"Patients from PPCC (observed cases)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percent", "OutcomeMeasureTimeFrame":"Baseline, 6, 12, 18 and 24 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Linagliptin 5mg + Metformin", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Linagliptin 5mg", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"132" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"113" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Change to week 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.97", "OutcomeMeasurementSpread":"0.09" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.33", "OutcomeMeasurementSpread":"0.10" } ] } } ] } },{ "OutcomeClassTitle":"Change to week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.69", "OutcomeMeasurementSpread":"0.11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.85", "OutcomeMeasurementSpread":"0.12" } ] } } ] } },{ "OutcomeClassTitle":"Change to week 18", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.79", "OutcomeMeasurementSpread":"0.11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.01", "OutcomeMeasurementSpread":"0.12" } ] } } ] } },{ "OutcomeClassTitle":"Change to week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.81", "OutcomeMeasurementSpread":"0.12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.01", "OutcomeMeasurementSpread":"0.13" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)", "OutcomeMeasureDescription":"The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.", "OutcomeMeasurePopulationDescription":"Patients from PPCC. Non-completers considered as failures.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline and 24 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Linagliptin 5mg + Metformin", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Linagliptin 5mg", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"132" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"113" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"124" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"92" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0031", "OutcomeAnalysisPValueComment":"The model includes treatment and continuous baseline HbA1c.", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"3.830", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"1.573", "OutcomeAnalysisCIUpperLimit":"9.328" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)", "OutcomeMeasureDescription":"The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.", "OutcomeMeasurePopulationDescription":"Patients from PPCC. Non-completers considered as failures.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline and 24 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Linagliptin 5mg + Metformin", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Linagliptin 5mg", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"132" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"113" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"116" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"82" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0025", "OutcomeAnalysisPValueComment":"The model includes treatment and continuous baseline HbA1c.", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"2.920", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"1.458", "OutcomeAnalysisCIUpperLimit":"5.849" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment", "OutcomeMeasureDescription":"The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.", "OutcomeMeasurePopulationDescription":"Patients from PPCC. Non-completers considered as failures.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline and 24 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Linagliptin 5mg + Metformin", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Linagliptin 5mg", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"132" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"113" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"81" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"45" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0008", "OutcomeAnalysisPValueComment":"The model includes treatment and continuous baseline HbA1c.", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"2.448", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"1.453", "OutcomeAnalysisCIUpperLimit":"4.123" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in FPG by Visit Over Time", "OutcomeMeasureDescription":"The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.", "OutcomeMeasurePopulationDescription":"Patients from PPCC, Observed Cases", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mg/dL", "OutcomeMeasureTimeFrame":"Baseline, 6, 12, 18 and 24 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Linagliptin 5mg + Metformin", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Linagliptin 5mg", "OutcomeGroupDescription":"Patients treated with linagliptin 5mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"132" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"113" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Change to week 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-52.3", "OutcomeMeasurementSpread":"3.37" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-31.9", "OutcomeMeasurementSpread":"3.67" } ] } } ] } },{ "OutcomeClassTitle":"Change to week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-54.1", "OutcomeMeasurementSpread":"3.49" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-30.5", "OutcomeMeasurementSpread":"3.77" } ] } } ] } },{ "OutcomeClassTitle":"Change to week 18", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-52.4", "OutcomeMeasurementSpread":"3.20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-35.4", "OutcomeMeasurementSpread":"3.46" } ] } } ] } },{ "OutcomeClassTitle":"Change to week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-47.1", "OutcomeMeasurementSpread":"3.88" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-30.1", "OutcomeMeasurementSpread":"4.16" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Up to 28 weeks", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Linagliptin 5mg + Metformin", "EventGroupDescription":"Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)", "EventGroupSeriousNumAffected":"3", "EventGroupSeriousNumAtRisk":"159", "EventGroupOtherNumAffected":"39", "EventGroupOtherNumAtRisk":"159" },{ "EventGroupId":"EG001", "EventGroupTitle":"Linagliptin 5mg", "EventGroupDescription":"Patients treated with linagliptin 5mg", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"157", "EventGroupOtherNumAffected":"51", "EventGroupOtherNumAtRisk":"157" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Coronary artery disease", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MEDDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"157" } ] } },{ "SeriousEventTerm":"Small intestinal obstruction", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MEDDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"157" } ] } },{ "SeriousEventTerm":"Umbilical hernia, obstructive", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MEDDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"157" } ] } },{ "SeriousEventTerm":"Thyroid neoplasm", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MEDDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"157" } ] } },{ "SeriousEventTerm":"Menstruation irregular", "SeriousEventOrganSystem":"Reproductive system and breast disorders", "SeriousEventSourceVocabulary":"MEDDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"157" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MEDDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"157" } ] } },{ "OtherEventTerm":"Urinary tract infection", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MEDDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"14", "OtherEventStatsNumAtRisk":"157" } ] } },{ "OtherEventTerm":"Dyslipidaemia", "OtherEventOrganSystem":"Metabolism and nutrition disorders", "OtherEventSourceVocabulary":"MEDDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"14", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"22", "OtherEventStatsNumAtRisk":"157" } ] } },{ "OtherEventTerm":"Hyperglycaemia", "OtherEventOrganSystem":"Metabolism and nutrition disorders", "OtherEventSourceVocabulary":"MEDDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"20", "OtherEventStatsNumAtRisk":"157" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MEDDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"157" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract." }, "PointOfContact":{ "PointOfContactTitle":"Boehringer Ingelheim Call Center", "PointOfContactOrganization":"Boehringer Ingelheim Pharmaceuticals", "PointOfContactEMail":"clintriage.rdg@boehringer-ingelheim.com", "PointOfContactPhone":"1-800-243-0127" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "Guatemala" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008687", "InterventionMeshTerm":"Metformin" },{ "InterventionMeshId":"D000069476", "InterventionMeshTerm":"Linagliptin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007004", "InterventionAncestorTerm":"Hypoglycemic Agents" },{ "InterventionAncestorId":"D000045505", 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