{ "FullStudy":{ "Rank":217743, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517412", "OrgStudyIdInfo":{ "OrgStudyId":"EFC12261" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-002416-85", "SecondaryIdType":"EudraCT Number" },{ "SecondaryId":"U1111-1118-0841", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"UTN" } ] }, "Organization":{ "OrgFullName":"Sanofi", "OrgClass":"INDUSTRY" }, "BriefTitle":"Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin", "OfficialTitle":"A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin" }, "StatusModule":{ "StatusVerifiedDate":"August 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 22, 2016", "ResultsFirstSubmitQCDate":"August 22, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"October 14, 2016", "ResultsFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"May 6, 2014", "DispFirstSubmitQCDate":"May 6, 2014", "DispFirstPostDateStruct":{ "DispFirstPostDate":"May 22, 2014", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 22, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 14, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Sanofi", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Primary Objective:\n\n- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)\n\nSecondary Objective:\n\nTo assess the effect of the 2 lixisenatide regimens on:\n\nThe percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24\nFasting Plasma Glucose (FPG)\n7-point Self-Monitored Plasma Glucose (SMPG) profiles\nBody weight\nTo assess the safety and tolerability of the 2 lixisenatide regimens", "DetailedDescription":"The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type 2 Diabetes Mellitus" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"451", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Lixisenatide Main Meal", "ArmGroupType":"Experimental", "ArmGroupDescription":"Lixisenatide 10 mcg once daily (QD) within 1 hour before \"main meal of the day\" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lixisenatide (AVE0010)", "Device: Self-injector pen device (OptiClik®)", "Drug: Metformin" ] } },{ "ArmGroupLabel":"Lixisenatide Breakfast", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Lixisenatide 10 mcg QD within 1 hour before \"breakfast\" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lixisenatide (AVE0010)", "Device: Self-injector pen device (OptiClik®)", "Drug: Metformin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Lixisenatide (AVE0010)", "InterventionDescription":"Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Lixisenatide Breakfast", "Lixisenatide Main Meal" ] } },{ "InterventionType":"Device", "InterventionName":"Self-injector pen device (OptiClik®)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Lixisenatide Breakfast", "Lixisenatide Main Meal" ] } },{ "InterventionType":"Drug", "InterventionName":"Metformin", "InterventionDescription":"To be kept at stable dose (≥1.5 g/day) throughout the study.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Lixisenatide Breakfast", "Lixisenatide Main Meal" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Route of administration: Oral" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in HbA1c From Baseline to Week 24", "PrimaryOutcomeDescription":"Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.", "PrimaryOutcomeTimeFrame":"Baseline, Week 24" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24", "SecondaryOutcomeDescription":"Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.", "SecondaryOutcomeTimeFrame":"Week 24" },{ "SecondaryOutcomeMeasure":"Change in Average 7-point SMPG Profiles From Baseline to Week 24", "SecondaryOutcomeDescription":"Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.", "SecondaryOutcomeTimeFrame":"Baseline, Week 24" },{ "SecondaryOutcomeMeasure":"Change in FPG From Baseline to Week 24", "SecondaryOutcomeDescription":"Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.", "SecondaryOutcomeTimeFrame":"Baseline, Week 24" },{ "SecondaryOutcomeMeasure":"Change in Body Weight From Baseline to Week 24", "SecondaryOutcomeDescription":"Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.", "SecondaryOutcomeTimeFrame":"Baseline, Week 24" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period", "SecondaryOutcomeDescription":"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.", "SecondaryOutcomeTimeFrame":"Week 24" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24", "SecondaryOutcomeDescription":"Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.", "SecondaryOutcomeTimeFrame":"Week 24" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period", "SecondaryOutcomeDescription":"Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.", "SecondaryOutcomeTimeFrame":"Week 24" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24", "SecondaryOutcomeDescription":"On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.", "SecondaryOutcomeTimeFrame":"Week 24" },{ "SecondaryOutcomeMeasure":"Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24", "SecondaryOutcomeDescription":"DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.", "SecondaryOutcomeTimeFrame":"Baseline, Week 24" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion criteria:\n\nParticipants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit\nMetformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.\n\nExclusion criteria:\n\nScreening HbA1c < 7.0% and > 10.0%\nFasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)\nTreatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin\nParticipants who usually did not eat breakfast\nType 1 diabetes mellitus\nBody Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2\nPregnancy or lactation, women of childbearing potential with no effective contraceptive method\nAmylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening\nAlanine aminotransferase (ALT) > 3 ULN at screening\nCalcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening\nHistory of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.\nPersonal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)\nAny contra-indication related to metformin\nAny previous treatment with lixisenatide\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Sciences & Operations", "OverallOfficialAffiliation":"Sanofi", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { 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"LocationFacility":"Investigational Site Number 724108", "LocationCity":"Segovia", "LocationZip":"40002", "LocationCountry":"Spain" },{ "LocationFacility":"Investigational Site Number 724105", "LocationCity":"Sevilla", "LocationZip":"41014", "LocationCountry":"Spain" },{ "LocationFacility":"Investigational Site Number 804108", "LocationCity":"Kharkiv", "LocationZip":"61002", "LocationCountry":"Ukraine" },{ "LocationFacility":"Investigational Site Number 804105", "LocationCity":"Kharkov", "LocationZip":"61022", "LocationCountry":"Ukraine" },{ "LocationFacility":"Investigational Site Number 804102", "LocationCity":"Kiev", "LocationZip":"2091", "LocationCountry":"Ukraine" },{ "LocationFacility":"Investigational Site Number 804103", "LocationCity":"Kyiv", "LocationZip":"04114", "LocationCountry":"Ukraine" },{ "LocationFacility":"Investigational Site Number 804104", "LocationCity":"Mykolaiv", "LocationZip":"54003", "LocationCountry":"Ukraine" },{ "LocationFacility":"Investigational Site Number 804106", "LocationCity":"Poltava", "LocationZip":"36011", "LocationCountry":"Ukraine" },{ "LocationFacility":"Investigational Site Number 804101", "LocationCity":"Zaporozhie", "LocationZip":"69600", "LocationCountry":"Ukraine" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25012990", "ReferenceType":"result", "ReferenceCitation":"Ahrén B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Participants were stratified according to main meal of day (breakfast, lunch or dinner) and screening values of HbA1c (<8% or ≥8%).", "FlowRecruitmentDetails":"The study was conducted at 82 centers in 10 countries. A total of 734 participants were screened between February 15, 2012 and October 16, 2012. 283 participants were screen failures; main reason for screen failure was that glycosylated hemoglobin (HbA1c) values were out of protocol defined range. 451 participants were randomized.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Lixisenatide Main Meal", "FlowGroupDescription":"Lixisenatide 10 mcg subcutaneous (SC) injection once daily (QD) within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Lixisenatide Breakfast", "FlowGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"225" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"226" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"189" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"202" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"36" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"24" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"10" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"11" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"10" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Poor compliance to protocol", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"8" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Other than specified above", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"8" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"5" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Lixisenatide Main Meal", "BaselineGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Lixisenatide Breakfast", "BaselineGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"225" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"226" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"451" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"56.3", "BaselineMeasurementSpread":"10.6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"57.5", "BaselineMeasurementSpread":"9.7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"56.9", "BaselineMeasurementSpread":"10.2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"124" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"129" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"253" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"101" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"97" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"198" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Caucasian/White", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"211" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"211" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"422" } ] } } ] } },{ "BaselineClassTitle":"Black", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" } ] } } ] } },{ "BaselineClassTitle":"Asian/Oriental", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"17" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ethnicity", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Hispanic", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"23" } ] } } ] } },{ "BaselineClassTitle":"Non-Hispanic", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"214" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"214" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"428" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Number of Participants with Categorical Body Mass Index (BMI)", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"<30 kg/m^2", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"51" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"60" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"111" } ] } } ] } },{ "BaselineClassTitle":"≥30 kg/m^2", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"174" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"166" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"340" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"BMI, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg/m^2", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"33.47", "BaselineMeasurementSpread":"4.50" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"32.77", "BaselineMeasurementSpread":"4.62" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"33.12", "BaselineMeasurementSpread":"4.57" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"HbA1c", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Percentage of hemoglobin", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7.85", "BaselineMeasurementSpread":"0.76" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7.93", "BaselineMeasurementSpread":"0.78" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7.89", "BaselineMeasurementSpread":"0.77" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Fasting Plasma Glucose (FPG)", "BaselineMeasureDescription":"N=225, 225", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mmol/L", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9.22", "BaselineMeasurementSpread":"2.03" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9.31", "BaselineMeasurementSpread":"2.04" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9.26", "BaselineMeasurementSpread":"2.03" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Average 7-point Self-monitored Plasma Glucose (SMPG)", "BaselineMeasureDescription":"N=211, 207", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mmol/L", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9.41", "BaselineMeasurementSpread":"2.01" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9.71", "BaselineMeasurementSpread":"2.13" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9.56", "BaselineMeasurementSpread":"2.07" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Duration of Diabetes", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6.69", "BaselineMeasurementSpread":"4.92" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7.78", "BaselineMeasurementSpread":"5.56" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7.24", "BaselineMeasurementSpread":"5.27" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Metformin Daily Dose", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2040.7", "BaselineMeasurementSpread":"390.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2091.2", "BaselineMeasurementSpread":"1255.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2066.0", "BaselineMeasurementSpread":"929.6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Randomization Strata of Main Meal of the Day", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Breakfast", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"40" } ] } } ] } },{ "BaselineClassTitle":"Lunch", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"116" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"117" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"233" } ] } } ] } },{ "BaselineClassTitle":"Dinner", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"89" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"89" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"178" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in HbA1c From Baseline to Week 24", "OutcomeMeasureDescription":"Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.", "OutcomeMeasurePopulationDescription":"Modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug and had both baseline and at least one post-baseline assessment of any primary or secondary efficacy endpoints, irrespective of compliance with study protocol and procedures.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Percentage of hemoglobin", "OutcomeMeasureTimeFrame":"Baseline, Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"218" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"222" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.65", "OutcomeMeasurementSpread":"0.074" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.74", "OutcomeMeasurementSpread":"0.074" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate.", "OutcomeAnalysisTestedNonInferiority":"Yes", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"A step-down procedure was used to control the type I error: non-inferiority of lixisenatide prior to the main meal of the day versus lixisenatide prior to breakfast was tested first. If non-inferiority was established, then a test of superiority of lixisenatide prior to the main meal of the day over lixisenatide prior to breakfast was to be performed. The non-inferiority was assessed using upper bound of 2-sided 95% CI at a level of ≤0.4%.", "OutcomeAnalysisParamType":"Least square (LS) mean difference", "OutcomeAnalysisParamValue":"0.09", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.067", "OutcomeAnalysisCIUpperLimit":"0.242", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.079", "OutcomeAnalysisEstimateComment":"Lixisenatide Main Meal vs Lixisenatide Breakfast" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.2664", "OutcomeAnalysisPValueComment":"Threshold for significance at 0.05 level.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"LS Mean Difference", "OutcomeAnalysisParamValue":"0.09", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.079", "OutcomeAnalysisEstimateComment":"Lixisenatide Main Meal vs Lixisenatide Breakfast" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24", "OutcomeMeasureDescription":"Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"218" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"222" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"HbA1c <7%", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"43.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"42.8" } ] } } ] } },{ "OutcomeClassTitle":"HbA1c ≤6.5%", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"25.7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Average 7-point SMPG Profiles From Baseline to Week 24", "OutcomeMeasureDescription":"Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"Baseline, Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"202" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"200" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.80", "OutcomeMeasurementSpread":"0.145" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.10", "OutcomeMeasurementSpread":"0.145" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in FPG From Baseline to Week 24", "OutcomeMeasureDescription":"Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"Baseline, Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"220" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"222" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.35", "OutcomeMeasurementSpread":"0.192" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.57", "OutcomeMeasurementSpread":"0.193" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Body Weight From Baseline to Week 24", "OutcomeMeasureDescription":"Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"kg", "OutcomeMeasureTimeFrame":"Baseline, Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"220" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"224" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.60", "OutcomeMeasurementSpread":"0.320" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.80", "OutcomeMeasurementSpread":"0.319" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period", "OutcomeMeasureDescription":"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"218" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"222" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"41.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24", "OutcomeMeasureDescription":"Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"218" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"223" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"38.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period", "OutcomeMeasureDescription":"Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"218" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"223" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"37.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24", "OutcomeMeasureDescription":"On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"218" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"221" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"27.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24", "OutcomeMeasureDescription":"DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.", "OutcomeMeasurePopulationDescription":"mITT population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 24", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lixisenatide Main Meal", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lixisenatide Breakfast", "OutcomeGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"204" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"215" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.01", "OutcomeMeasurementSpread":"0.546" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.54", "OutcomeMeasurementSpread":"0.529" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 171) regardless of seriousness or relationship to investigational medicinal product (IMP).", "EventsDescription":"Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the first dose of study drug up to 3 days after the last dose of study drug). Safety population defined as all randomized participants who received at least one dose of study drug.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Lixisenatide Main Meal", "EventGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.", "EventGroupSeriousNumAffected":"7", "EventGroupSeriousNumAtRisk":"225", "EventGroupOtherNumAffected":"65", "EventGroupOtherNumAtRisk":"225" },{ "EventGroupId":"EG001", "EventGroupTitle":"Lixisenatide Breakfast", "EventGroupDescription":"Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.", "EventGroupSeriousNumAffected":"7", "EventGroupSeriousNumAtRisk":"226", "EventGroupOtherNumAffected":"60", "EventGroupOtherNumAtRisk":"226" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Cellulitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Postoperative wound infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Clear cell renal cell carcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Cerebral infarction", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Peripheral arterial occlusive disease", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Abdominal hernia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Abdominal strangulated hernia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Osteoarthritis", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Renal colic", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Cystitis noninfective", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Calculus ureteric", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"226" } ] } },{ "SeriousEventTerm":"Contusion", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"225" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"226" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Nasopharyngitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"22", "OtherEventStatsNumAtRisk":"225" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"16", "OtherEventStatsNumAtRisk":"226" } ] } },{ "OtherEventTerm":"Hypoglycaemia", "OtherEventOrganSystem":"Metabolism and nutrition disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"15", "OtherEventStatsNumAtRisk":"225" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"226" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"225" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"16", "OtherEventStatsNumAtRisk":"226" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 16.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"33", "OtherEventStatsNumAtRisk":"225" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"35", "OtherEventStatsNumAtRisk":"226" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights." }, "PointOfContact":{ "PointOfContactTitle":"Trial Transparency Team", "PointOfContactOrganization":"Sanofi", "PointOfContactEMail":"Contact-US@sanofi.com" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008687", "InterventionMeshTerm":"Metformin" },{ "InterventionMeshId":"C000479460", "InterventionMeshTerm":"Lixisenatide" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007004", "InterventionAncestorTerm":"Hypoglycemic Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10250", "InterventionBrowseLeafName":"Metformin", "InterventionBrowseLeafAsFound":"Metformin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M257201", "InterventionBrowseLeafName":"Lixisenatide", "InterventionBrowseLeafAsFound":"Lixisenatide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8637", "InterventionBrowseLeafName":"Hypoglycemic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003924", "ConditionMeshTerm":"Diabetes Mellitus, Type 2" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000003920", "ConditionAncestorTerm":"Diabetes Mellitus" },{ "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5702", "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2", "ConditionBrowseLeafAsFound":"Type 2 Diabetes Mellitus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }