{ "FullStudy":{ "Rank":217570, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519674", "OrgStudyIdInfo":{ "OrgStudyId":"BIASP-3963" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"U1111-1125-0850", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"WHO" },{ "SecondaryId":"2011-004930-33", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin", "OfficialTitle":"A 24 Week Randomised, Open Label, 3 Parallel-group Comparison of Once and Twice Daily Biphasic Insulin Aspart (BIAsp) 30 Plus Sitagliptin and Twice Daily BIAsp 30, All in Combination With Metformin in Insulin naïve Type 2 Diabetic Subjects Inadequately Controlled on Sitagliptin and Metformin", "Acronym":"SIT2MIX" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"October 17, 2014", "ResultsFirstSubmitQCDate":"November 5, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"November 10, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 10, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 24, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novo Nordisk A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)).\n\nThe trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes", "Diabetes Mellitus, Type 2" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"582", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"BIAsp 30 BID + sitagliptin + metformin", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: biphasic insulin aspart 30", "Drug: sitagliptin", "Drug: metformin" ] } },{ "ArmGroupLabel":"BIAsp 30 BID + metformin", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: biphasic insulin aspart 30", "Drug: metformin" ] } },{ "ArmGroupLabel":"BIAsp 30 OD + sitagliptin + metformin", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: biphasic insulin aspart 30", "Drug: sitagliptin", "Drug: metformin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"biphasic insulin aspart 30", "InterventionDescription":"BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BIAsp 30 BID + metformin", "BIAsp 30 BID + sitagliptin + metformin" ] } },{ "InterventionType":"Drug", "InterventionName":"biphasic insulin aspart 30", "InterventionDescription":"BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BIAsp 30 OD + sitagliptin + metformin" ] } },{ "InterventionType":"Drug", "InterventionName":"sitagliptin", "InterventionDescription":"Subjects will continue on their pre-trial sitagliptin treatment.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BIAsp 30 BID + sitagliptin + metformin", "BIAsp 30 OD + sitagliptin + metformin" ] } },{ "InterventionType":"Drug", "InterventionName":"metformin", "InterventionDescription":"Subjects will continue on their pre-trial metformin treatment.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BIAsp 30 BID + metformin", "BIAsp 30 BID + sitagliptin + metformin", "BIAsp 30 OD + sitagliptin + metformin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in HbA1c (Glycosylated Haemoglobin)", "PrimaryOutcomeDescription":"Estimated mean change from baseline in HbA1c after 24 weeks of treatment.", "PrimaryOutcomeTimeFrame":"Week 0 to Week 24" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)", "SecondaryOutcomeDescription":"Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment", "SecondaryOutcomeTimeFrame":"After 24 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)", "SecondaryOutcomeDescription":"Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.", "SecondaryOutcomeTimeFrame":"After 24 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Fasting Plasma Glucose (FPG)", "SecondaryOutcomeDescription":"Estimated mean change from baseline in fasting plasma glucose (FPG)", "SecondaryOutcomeTimeFrame":"Week 0 to Week 24" },{ "SecondaryOutcomeMeasure":"Prandial Plasma Glucose (PPG) Increments at Breakfast", "SecondaryOutcomeDescription":"Estimated mean post prandial increments at breakfast after 24 weeks of treatment.", "SecondaryOutcomeTimeFrame":"After 24 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Prandial Plasma Glucose (PPG) Increments at Lunch.", "SecondaryOutcomeDescription":"Estimated mean post prandial increments at lunch after 24 weeks of treatment.", "SecondaryOutcomeTimeFrame":"After 24 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Prandial Plasma Glucose (PPG) Increments at Dinner.", "SecondaryOutcomeDescription":"Estimated mean post prandial increments at dinner after 24 weeks of treatment.", "SecondaryOutcomeTimeFrame":"After 24 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Prandial Plasma Glucose (PPG) Overall Mean Increment.", "SecondaryOutcomeDescription":"Estimated overall mean post prandial increment after 24 weeks of treatment.", "SecondaryOutcomeTimeFrame":"After 24 weeks of treatment" },{ "SecondaryOutcomeMeasure":"Adverse Events (AEs)", "SecondaryOutcomeDescription":"Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.", "SecondaryOutcomeTimeFrame":"Week 0 to Week 24" },{ "SecondaryOutcomeMeasure":"Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.", "SecondaryOutcomeDescription":"Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.", "SecondaryOutcomeTimeFrame":"Week 0 to Week 24" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.", "SecondaryOutcomeDescription":"Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0−100 scale with higher scores indicating greater satisfaction.", "SecondaryOutcomeTimeFrame":"Week 0 to Week 24" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosed with type 2 diabetes for a minimum of 6 months prior to screening (Visit 1)\nStable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (OADs) treatment). The metformin dose must have been unchanged for at least 3 months prior to screening (Visit 1)\nStable treatment with a total daily dose of at least 100 mg sitagliptin. The sitagliptin dose must have been unchanged for at least 3 months prior to screening (Visit 1)\nSubject is insulin-naïve (never previously treated with insulin). (However, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)\nHbA1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other OADs)\nBody Mass Index (BMI) below or equal to 40.0 kg/m^2\nAble and willing to eat at least 2 meals (breakfast and dinner) every day during the trial\n\nExclusion Criteria:\n\nTreatment with thiazolidinedione (TZD) or glucagon-like-peptide-1 (GLP-1) receptor agonist within the last 3 months prior to screening (Visit 1)\nCardiac disease within the last 6 months prior to screening (Visit 1), defined as: decompensated heart failure New York Heart Association (NYHA) class III or IV; unstable angina pectoris; or myocardial infarction\nSevere hypertension, systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (Visit 1)\nAnticipated change of dose of any systemic treatment with products, which in the trial physician's opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)\nClinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physician's opinion may confound the results of the trial or pose additional risk in administering trial product(s)\nImpaired hepatic function as indicated by aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) above 2.5 times the upper normal range, according to central laboratory reference ranges\nImpaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/L (1.5 mg/dL) for males and equal to or above 124 micromol/L (1.4 mg/dL) for females or estimated creatinine clearance below 60 mL/min, based on the Cockroft & Gault formula and according to local practise for metformin use", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Global Clinical Registry (GCR, 1452)", "OverallOfficialAffiliation":"Novo Nordisk A/S", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Buenos Aires", "LocationZip":"B1704ETD", "LocationCountry":"Argentina" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Buenos Aires", "LocationZip":"C1250AAN", "LocationCountry":"Argentina" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Caba", "LocationZip":"C1179AAB", "LocationCountry":"Argentina" },{ "LocationFacility":"Novo Nordisk Investigational Site", "LocationCity":"Caba", "LocationZip":"C1440AAD", 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Investigational Site", "LocationCity":"Istanbul", "LocationZip":"34890", "LocationCountry":"Turkey" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25488587", "ReferenceType":"result", "ReferenceCitation":"Linjawi S, Sothiratnam R, Sari R, Andersen H, Hiort LC, Rao P. The study of once- and twice-daily biphasic insulin aspart 30 (BIAsp 30) with sitagliptin, and twice-daily BIAsp 30 without sitagliptin, in patients with type 2 diabetes uncontrolled on sitagliptin and metformin-The Sit2Mix trial. Prim Care Diabetes. 2015 Oct;9(5):370-6. doi: 10.1016/j.pcd.2014.11.001. Epub 2014 Dec 3." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk", "SeeAlsoLinkURL":"http://novonordisk-trials.com" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Subjects on pre-trial metformin (1000 mg/day) (± additional OAD treatment) continued their medication. Subjects on pre-trial sitagliptin (100 mg/day) either continued or discontinued their sitagliptin treatment depending on the treatment group the subjects were randomised to.", "FlowRecruitmentDetails":"The trial was conducted at 60 sites in 10 countries as follows:\n\nArgentina (6); Australia (2); Brazil (4); Greece (5); India (17); Malaysia (3); Portugal (6); Republic of Korea (7); Thailand (5); Turkey (5)", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"BID + Met", "FlowGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"BID + Sita + Met", "FlowGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"OD + Sita + Met", "FlowGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"194" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"195" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"193" } ] } },{ "FlowMilestoneType":"Exposed", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"192" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"193" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"190" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"173" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"182" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"181" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"21" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"13" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"12" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Withdrawal Criteria", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"7" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"7" } ] } },{ "FlowDropWithdrawType":"Unsclassified", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"10" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"3" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"BID + Met", "BaselineGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"BID + Sita + Met", "BaselineGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"OD + Sita + Met", "BaselineGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"194" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"195" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"193" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"582" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"54.8", "BaselineMeasurementSpread":"9.5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"56.3", "BaselineMeasurementSpread":"10.2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"55.7", "BaselineMeasurementSpread":"10.4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"55.6", "BaselineMeasurementSpread":"10.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Gender", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"83" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"101" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"97" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"281" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"111" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"94" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"96" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"301" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Weight", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"79.4", "BaselineMeasurementSpread":"15.8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"78.3", "BaselineMeasurementSpread":"16.1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"77.5", "BaselineMeasurementSpread":"16.8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"78.4", "BaselineMeasurementSpread":"16.2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Mass Index (BMI)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg/m^2", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"29.3", "BaselineMeasurementSpread":"4.3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"29.4", "BaselineMeasurementSpread":"4.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"29.4", "BaselineMeasurementSpread":"5.0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"29.4", "BaselineMeasurementSpread":"4.6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Glycosylated haemoglobin (HbA1c)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Percent (%) glycosylated haemoglobin", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8.4", "BaselineMeasurementSpread":"0.8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8.4", "BaselineMeasurementSpread":"0.8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8.4", "BaselineMeasurementSpread":"0.8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"8.4", "BaselineMeasurementSpread":"0.8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Fasting plasma glucose (FPG)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mmol/L", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8.9", "BaselineMeasurementSpread":"2.2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9.3", "BaselineMeasurementSpread":"2.8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8.7", "BaselineMeasurementSpread":"2.7" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"9.0", "BaselineMeasurementSpread":"2.6" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in HbA1c (Glycosylated Haemoglobin)", "OutcomeMeasureDescription":"Estimated mean change from baseline in HbA1c after 24 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"percentage of glycosylated haemoglobin", "OutcomeMeasureTimeFrame":"Week 0 to Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"183" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"189" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"187" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.27", "OutcomeMeasurementSpread":"0.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.51", "OutcomeMeasurementSpread":"0.07" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-1.15", "OutcomeMeasurementSpread":"0.07" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by:\n\nH0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Met and BID+Sita+Met).", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.011", "OutcomeAnalysisPValueComment":"No corrections for multiplicity were performed.", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.24", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"0.06", "OutcomeAnalysisCIUpperLimit":"0.43" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.231", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-0.11", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.30", "OutcomeAnalysisCIUpperLimit":"0.07" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisGroupDescription":"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-0.36", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.54", "OutcomeAnalysisCIUpperLimit":"-0.17" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)", "OutcomeMeasureDescription":"Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage (%) of subjects", "OutcomeMeasureTimeFrame":"After 24 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"183" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"189" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"187" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"49.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"59.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"46.5" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.022", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"0.60", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"0.39", "OutcomeAnalysisCIUpperLimit":"0.93" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.618", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.12", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"0.73", "OutcomeAnalysisCIUpperLimit":"1.71" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.005", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.85", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"1.20", "OutcomeAnalysisCIUpperLimit":"2.85" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)", "OutcomeMeasureDescription":"Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage (%) of subjects", "OutcomeMeasureTimeFrame":"After 24 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"183" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"189" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"187" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"40.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"25.1" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.020", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"0.59", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"0.38", "OutcomeAnalysisCIUpperLimit":"0.92" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.286", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.29", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"0.81", "OutcomeAnalysisCIUpperLimit":"2.07" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"2.20", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"1.39", "OutcomeAnalysisCIUpperLimit":"3.47" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Fasting Plasma Glucose (FPG)", "OutcomeMeasureDescription":"Estimated mean change from baseline in fasting plasma glucose (FPG)", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 556 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"Week 0 to Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"181" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"188" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"187" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.90", "OutcomeMeasurementSpread":"0.14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.03", "OutcomeMeasurementSpread":"0.14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-1.96", "OutcomeMeasurementSpread":"0.14" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.520", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.13", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.26", "OutcomeAnalysisCIUpperLimit":"0.52" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.788", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.05", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.34", "OutcomeAnalysisCIUpperLimit":"0.45" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.708", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-0.07", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.46", "OutcomeAnalysisCIUpperLimit":"0.31" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Prandial Plasma Glucose (PPG) Increments at Breakfast", "OutcomeMeasureDescription":"Estimated mean post prandial increments at breakfast after 24 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 555 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"After 24 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"184" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"187" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"184" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.01", "OutcomeMeasurementSpread":"0.19" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.73", "OutcomeMeasurementSpread":"0.19" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.89", "OutcomeMeasurementSpread":"0.19" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.291", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.28", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.24", "OutcomeAnalysisCIUpperLimit":"0.81" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.001", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-0.88", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-1.41", "OutcomeAnalysisCIUpperLimit":"-0.35" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-1.16", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-1.69", "OutcomeAnalysisCIUpperLimit":"-0.64" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Prandial Plasma Glucose (PPG) Increments at Lunch.", "OutcomeMeasureDescription":"Estimated mean post prandial increments at lunch after 24 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 548 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"After 24 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"180" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"186" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"182" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.05", "OutcomeMeasurementSpread":"0.22" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.19", "OutcomeMeasurementSpread":"0.21" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.52", "OutcomeMeasurementSpread":"0.21" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.005", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.85", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"0.26", "OutcomeAnalysisCIUpperLimit":"1.45" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.085", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.52", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.07", "OutcomeAnalysisCIUpperLimit":"1.12" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.275", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-0.33", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.92", "OutcomeAnalysisCIUpperLimit":"0.26" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Prandial Plasma Glucose (PPG) Increments at Dinner.", "OutcomeMeasureDescription":"Estimated mean post prandial increments at dinner after 24 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 550 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"After 24 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"178" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"188" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"184" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.89", "OutcomeMeasurementSpread":"0.21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.01", "OutcomeMeasurementSpread":"0.20" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.17", "OutcomeMeasurementSpread":"0.21" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.674", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-0.12", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.70", "OutcomeAnalysisCIUpperLimit":"0.45" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.015", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.72", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"0.14", "OutcomeAnalysisCIUpperLimit":"1.30" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.004", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.84", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"0.27", "OutcomeAnalysisCIUpperLimit":"1.41" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Prandial Plasma Glucose (PPG) Overall Mean Increment.", "OutcomeMeasureDescription":"Estimated overall mean post prandial increment after 24 weeks of treatment.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 557 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"After 24 weeks of treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"184" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"188" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"185" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.97", "OutcomeMeasurementSpread":"0.12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.66", "OutcomeMeasurementSpread":"0.12" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.88", "OutcomeMeasurementSpread":"0.12" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.080", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.31", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.04", "OutcomeAnalysisCIUpperLimit":"0.65" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.613", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.09", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.26", "OutcomeAnalysisCIUpperLimit":"0.43" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.213", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-0.22", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-0.56", "OutcomeAnalysisCIUpperLimit":"0.13" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Adverse Events (AEs)", "OutcomeMeasureDescription":"Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all subjects receiving at least one dose of the investigational product.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Events/100 years of patient exposure", "OutcomeMeasureTimeFrame":"Week 0 to Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"192" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"193" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"190" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"All treatment emergent adverse events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"262.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"209.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"281.2" } ] } } ] } },{ "OutcomeClassTitle":"Serious adverse events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"10.5" } ] } } ] } },{ "OutcomeClassTitle":"Severe adverse events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7.0" } ] } } ] } },{ "OutcomeClassTitle":"Moderate adverse events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"71.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"74.6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"79.7" } ] } } ] } },{ "OutcomeClassTitle":"Mild adverse events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"185.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"124.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"194.5" } ] } } ] } },{ "OutcomeClassTitle":"Fatal adverse events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.", "OutcomeMeasureDescription":"Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all subjects receiving at least one dose of the investigational product.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"episodes", "OutcomeMeasureTimeFrame":"Week 0 to Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"192" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"193" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"190" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Diurnal (ADA)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"515" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"440" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"249" } ] } } ] } },{ "OutcomeClassTitle":"Nocturnal (ADA)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"68" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"54" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"63" } ] } } ] } },{ "OutcomeClassTitle":"Diurnal (additional minor)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"163" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"112" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"71" } ] } } ] } },{ "OutcomeClassTitle":"Nocturnal (additional minor)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"23" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.", "OutcomeMeasureDescription":"Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0−100 scale with higher scores indicating greater satisfaction.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 545 subjects contributed to the statistical analysis at Week 24.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"scores", "OutcomeMeasureTimeFrame":"Week 0 to Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BID + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BID + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"OD + Sita + Met", "OutcomeGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"178" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"184" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"183" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.22", "OutcomeMeasurementSpread":"0.82" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.93", "OutcomeMeasurementSpread":"0.81" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6.20", "OutcomeMeasurementSpread":"0.81" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.800", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.29", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-1.97", "OutcomeAnalysisCIUpperLimit":"2.56" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.989", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"0.02", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-2.26", "OutcomeAnalysisCIUpperLimit":"2.29" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.809", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisParamType":"Estimated treatment difference", "OutcomeAnalysisParamValue":"-0.28", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-2.52", "OutcomeAnalysisCIUpperLimit":"1.97" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events were captured the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.", "EventsDescription":"Safety analysis set included all subjects receiving at least one dose of the investigational product.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"BID + Met", "EventGroupDescription":"Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. 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Novo Nordisk reserves the right to prior review of such publications and to ask for delay of publication of individual site results until after the primary manuscript is accepted for publication." }, "PointOfContact":{ "PointOfContactTitle":"Public Access to Clinical Trials", "PointOfContactOrganization":"Novo Nordisk A/S", "PointOfContactEMail":"clinicaltrials@novonordisk.com" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007328", "InterventionMeshTerm":"Insulin" },{ "InterventionMeshId":"C000557859", "InterventionMeshTerm":"Insulin, Globin Zinc" },{ "InterventionMeshId":"D000008687", "InterventionMeshTerm":"Metformin" },{ "InterventionMeshId":"D000061267", "InterventionMeshTerm":"Insulin Aspart" },{ "InterventionMeshId":"D000049528", "InterventionMeshTerm":"Insulin, Long-Acting" },{ "InterventionMeshId":"C000578220", "InterventionMeshTerm":"Insulin 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