{ "FullStudy":{ "Rank":217993, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514149", "OrgStudyIdInfo":{ "OrgStudyId":"DM200-103" }, "Organization":{ "OrgFullName":"ConjuChem", "OrgClass":"INDUSTRY" }, "BriefTitle":"Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy", "OfficialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of 17 Weeks of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy" }, "StatusModule":{ "StatusVerifiedDate":"June 2017", "OverallStatus":"Terminated", "WhyStopped":"Business decision", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"September 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"October 20, 2011", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 2, 2017", "ResultsFirstSubmitQCDate":"June 21, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 19, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"June 21, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 19, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"ConjuChem", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.", "DetailedDescription":"DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.\n\nPatients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.\n\nCJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type 2 Diabetes Mellitus (T2DM)" ] }, "KeywordList":{ "Keyword":[ "Type 2 Diabetes Mellitus", "T2DM", "diabetes", "ConjuChem", "GLP-1", "Glucagon-like peptide-1", "exendin-4", "modified exendin-4" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"73", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm 1 - Weekly CJC-1134-PC", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: CJC-1134-PC Injection" ] } },{ "ArmGroupLabel":"Arm 2 - Weekly CJC-1134-PC", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: CJC-1134-PC Injection" ] } },{ "ArmGroupLabel":"Arm 3 - Weekly CJC-1134-PC", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: CJC-1134-PC Injection" ] } },{ "ArmGroupLabel":"Arm 4 - Weekly CJC-1134-PC", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: CJC-1134-PC Injection" ] } },{ "ArmGroupLabel":"Arm 5 - Weekly Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Weekly placebo for CJC-1134-PC Injection" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"CJC-1134-PC Injection", "InterventionDescription":"CJC-1134-PC administered weekly by subcutaneous injection", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 1 - Weekly CJC-1134-PC", "Arm 2 - Weekly CJC-1134-PC", "Arm 3 - Weekly CJC-1134-PC", "Arm 4 - Weekly CJC-1134-PC" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "metformin" ] } },{ "InterventionType":"Drug", "InterventionName":"Weekly placebo for CJC-1134-PC Injection", "InterventionDescription":"Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 5 - Weekly Placebo" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "metformin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18", "PrimaryOutcomeTimeFrame":"CFB to Week 18" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Fasting Body Weight CFB to Week 18", "SecondaryOutcomeTimeFrame":"CFB to Week 18" },{ "SecondaryOutcomeMeasure":"Time to Hyperglycemia Rescue", "SecondaryOutcomeTimeFrame":"18 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMen or women 18 to 70 years of age, inclusive\nBody mass index of 27 to 45 kg/m2\nDiagnosed with T2DM for at least 6 months before screening\nStable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening\nFPG ≤240 mg/dL at screening\nHbA1c ≥7.0% and ≤11% at screening\nA 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval\n\nExclusion Criteria:\n\nPregnant or breastfeeding women\nUse of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening\nTreatment with any oral antidiabetic agent other than metformin within the 3 months before screening\nTreatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening\nPrevious treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy\nReceipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Patrick Soon-Shiong, MD", "OverallOfficialAffiliation":"Chief Executive Officer", "OverallOfficialRole":"Study Director" },{ "OverallOfficialName":"Robert Henry, MD", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Research Site", "LocationCity":"Phoenix", "LocationState":"Arizona", "LocationZip":"85018", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Inglewood", "LocationState":"California", "LocationZip":"90301", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Tarzana", "LocationState":"California", "LocationZip":"91356", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Ventura", "LocationState":"California", "LocationZip":"93003", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Wellington", "LocationState":"Florida", "LocationZip":"33414", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Idaho Falls", "LocationState":"Idaho", "LocationZip":"83404", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Lexington", "LocationState":"Kentucky", "LocationZip":"40504", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Brighton", "LocationState":"Massachusetts", "LocationZip":"02135", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Greensboro", "LocationState":"North Carolina", "LocationZip":"27405", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Eugene", "LocationState":"Oregon", "LocationZip":"97401", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Altoona", "LocationState":"Pennsylvania", "LocationZip":"16602", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"East Providence", "LocationState":"Rhode Island", "LocationZip":"02915", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Charleston", "LocationState":"South Carolina", "LocationZip":"29407", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Taylors", "LocationState":"South Carolina", "LocationZip":"29687", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Austin", "LocationState":"Texas", "LocationZip":"78758", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75231", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"San Antonio", "LocationState":"Texas", "LocationZip":"78249", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Salt Lake City", "LocationState":"Utah", "LocationZip":"84107", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Henrico", "LocationState":"Virginia", "LocationZip":"23233", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Vancouver", "LocationState":"British Columbia", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"Smiths Falls", "LocationState":"Ontario", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"Toronto", "LocationState":"Ontario", "LocationCountry":"Canada" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Arm 1 - Weekly CJC-1134-PC", "FlowGroupDescription":"CJC-1134-PC, 1.5 mg. weekly subcutaneous injection" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Arm 2 - Weekly CJC-1134-PC", "FlowGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Arm 3 - Weekly CJC-1134-PC", "FlowGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection" },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Arm 4 - Weekly CJC-1134-PC", "FlowGroupDescription":"CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection" },{ "FlowGroupId":"FG004", "FlowGroupTitle":"Arm 5 - Weekly Placebo", "FlowGroupDescription":"Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"15" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"11" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"13" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"14" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Intent to Treat population", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Arm 1 - Weekly CJC-1134-PC", "BaselineGroupDescription":"CJC-1134-PC, 1.5 mg. weekly subcutaneous injection" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Arm 2 - Weekly CJC-1134-PC", "BaselineGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Arm 3 - Weekly CJC-1134-PC", "BaselineGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Arm 4 - Weekly CJC-1134-PC", "BaselineGroupDescription":"CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection" },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Arm 5 - Weekly Placebo", "BaselineGroupDescription":"Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection" },{ "BaselineGroupId":"BG005", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"15" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"15" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"14" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"14" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"15" },{ "BaselineDenomCountGroupId":"BG005", "BaselineDenomCountValue":"73" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"18 to 70 years", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"15" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"15" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"14" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"14" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"15" },{ "BaselineClassDenomCountGroupId":"BG005", "BaselineClassDenomCountValue":"73" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"73" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"15" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"15" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"14" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"14" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"15" },{ "BaselineClassDenomCountGroupId":"BG005", "BaselineClassDenomCountValue":"73" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"31" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"42" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race and Ethnicity Not Collected", "BaselineMeasurePopulationDescription":"Race and Ethnicity were not collected from any participant.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG005", "BaselineClassDenomCountValue":"0" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18", "OutcomeMeasurePopulationDescription":"Completed Population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Percent (%)", "OutcomeMeasureTimeFrame":"CFB to Week 18", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, 1.5 mg. weekly subcutaneous injection" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Arm 3 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Arm 4 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Arm 5 - Weekly Placebo", "OutcomeGroupDescription":"Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.56", "OutcomeMeasurementSpread":"0.597" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.56", "OutcomeMeasurementSpread":"0.627" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.95", "OutcomeMeasurementSpread":"0.746" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.95", "OutcomeMeasurementSpread":"0.828" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-0.13", "OutcomeMeasurementSpread":"0.811" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Fasting Body Weight CFB to Week 18", "OutcomeMeasurePopulationDescription":"Completed Population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"kg", "OutcomeMeasureTimeFrame":"CFB to Week 18", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, 1.5 mg. weekly subcutaneous injection" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Arm 3 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Arm 4 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Arm 5 - Weekly Placebo", "OutcomeGroupDescription":"Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.91", "OutcomeMeasurementSpread":"1.624" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.14", "OutcomeMeasurementSpread":"4.122" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-1.37", "OutcomeMeasurementSpread":"2.182" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.92", "OutcomeMeasurementSpread":"1.999" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-1.85", "OutcomeMeasurementSpread":"4.083" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Hyperglycemia Rescue", "OutcomeMeasurePopulationDescription":"Completed Population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"18 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, 1.5 mg. weekly subcutaneous injection" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Arm 3 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Arm 4 - Weekly CJC-1134-PC", "OutcomeGroupDescription":"CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Arm 5 - Weekly Placebo", "OutcomeGroupDescription":"Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"0 patient with hyperglycemia rescue" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"47.0", "OutcomeMeasurementSpread":"53.74" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"0 patient with hyperglycemia rescue" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"0 patient with hyperglycemia rescue" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"57.0", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"Only 1 patient with hyperglycemia rescue" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"18 weeks", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Arm 1 - Weekly CJC-1134-PC", "EventGroupDescription":"CJC-1134-PC, 1.5 mg. weekly subcutaneous injection", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"12", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"12", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"12" },{ "EventGroupId":"EG001", 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