{"protocolSection":{"identificationModule":{"nctId":"NCT02750410","orgStudyIdInfo":{"id":"15803"},"secondaryIdInfos":[{"id":"H9X-JE-GBGF","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes","officialTitle":"A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication in Patients With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-08"},"primaryCompletionDateStruct":{"date":"2018-06-18","type":"ACTUAL"},"completionDateStruct":{"date":"2018-06-18","type":"ACTUAL"},"studyFirstSubmitDate":"2016-04-21","studyFirstSubmitQcDate":"2016-04-21","studyFirstPostDateStruct":{"date":"2016-04-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-06-14","resultsFirstSubmitQcDate":"2019-08-13","resultsFirstPostDateStruct":{"date":"2019-09-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-09-16","lastUpdatePostDateStruct":{"date":"2019-09-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes."},"conditionsModule":{"conditions":["Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":159,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Dulaglutide","type":"EXPERIMENTAL","description":"Dulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks. After 16-weeks, dulaglutide administered once weekly for 36 weeks.","interventionNames":["Drug: Dulaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo administered once weekly for 16 weeks. After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks.","interventionNames":["Drug: Dulaglutide","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Dulaglutide","description":"Administered subcutaneously (SC)","armGroupLabels":["Dulaglutide","Placebo"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.","timeFrame":"Baseline, Week 16"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With HbA1c <7.0% or ≤6.5%","description":"Percentage of participants whose HbA1c was \\<7.0% or ≤6.5%. HbA1c \\<7.0% is presented.","timeFrame":"Week 16"},{"measure":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"The LS mean change from baseline in FSG was calculated using a REML based MMRM and adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c Group (\\<8.5%, \\>=8.5%) + insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.","timeFrame":"Baseline, Week 16"},{"measure":"Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: prebreakfast blood glucose (BG), breakfast 2-hour postprandial blood glucose (PPBG), prelunch BG, lunch 2-hour PPBG, predinner BG, dinner 2-hour PPBG, and bedtime BG. LS mean was calculated with fixed effect test of analysis of covariance (ANCOVA) model and adjusted by, baseline value, treatment, baseline HbA1c Group (\\<8.5%, ≥8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin).","timeFrame":"Baseline, Week 16"},{"measure":"Change From Baseline in Body Weight","description":"LS mean change from baseline in body weight was calculated using a REML based MMRM and was adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c group (\\<8.5%, \\>=8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.","timeFrame":"Baseline, Week 16"},{"measure":"Change From Baseline in Daily Total Insulin Dose","description":"Mean change from baseline in total insulin dose was measured in each treatment groups.","timeFrame":"Baseline, Week 16"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants who have had a diagnosis of type 2 diabetes mellitus\n* Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening\n* Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 \\[DPP-4\\] inhibitors, sulfonylurea \\[SU\\], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs\n* Participants who have stable weight (±5%) ≥3 months prior to screening\n* Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\\^2)\n\nExclusion Criteria:\n\n* Participants who have a diagnosis of type 1 diabetes\n* Participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening\n* Participants who have been previously treated with dulaglutide prior to screening\n* Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide)\n* Participants who have been treated with continuous subcutaneous insulin infusion (CSII) at screening\n* Participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities\n* Participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Adachi-ku","zip":"123-0845","country":"Japan"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chiba","zip":"2610004","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chiyoda City","zip":"102-0082","country":"Japan","geoPoint":{"lat":35.68449,"lon":139.75056}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chuou-ku","zip":"1030002","country":"Japan"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chūōku","zip":"103-0027","country":"Japan","geoPoint":{"lat":33.63867,"lon":130.67068}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Chūōku","zip":"103-0028","country":"Japan","geoPoint":{"lat":33.63867,"lon":130.67068}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Fuchū","zip":"183-8524","country":"Japan","geoPoint":{"lat":35.67452,"lon":139.48216}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ichikawa","zip":"272-8516","country":"Japan","geoPoint":{"lat":35.73413,"lon":139.9065}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Isahaya","zip":"8548501","country":"Japan","geoPoint":{"lat":32.84111,"lon":130.04306}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Kamakura","zip":"247-0056","country":"Japan","geoPoint":{"lat":35.31085,"lon":139.54698}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Kashihara","zip":"634-8522","country":"Japan","geoPoint":{"lat":34.58333,"lon":135.61667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kumamoto","zip":"862-0965","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Kumamoto","zip":"862-0976","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Maebashi","zip":"3710821","country":"Japan","geoPoint":{"lat":36.4,"lon":139.08333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Mito","zip":"310-0845","country":"Japan","geoPoint":{"lat":36.35,"lon":140.45}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Naka","zip":"311-0113","country":"Japan","geoPoint":{"lat":36.05,"lon":140.16667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Nishinomiya","zip":"662-0971","country":"Japan","geoPoint":{"lat":34.71562,"lon":135.33199}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Osaka","zip":"530-0001","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Ōita","zip":"870-0039","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Sasebo","zip":"857-1195","country":"Japan","geoPoint":{"lat":33.16834,"lon":129.72502}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Shimotsuke","zip":"329-0433","country":"Japan","geoPoint":{"lat":36.41323,"lon":139.86622}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Shizuoka","zip":"424-0855","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician","city":"Tama","zip":"206-0633","country":"Japan","geoPoint":{"lat":35.6436,"lon":139.46844}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Toda","zip":"335-0023","country":"Japan","geoPoint":{"lat":40.15,"lon":141.41667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Yokohama","zip":"241-0821","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}}]},"referencesModule":{"references":[{"pmid":"31994009","type":"DERIVED","citation":"Onishi Y, Ishii H, Oura T, Takeuchi M. Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen. Diabetes Ther. 2020 Mar;11(3):735-745. doi: 10.1007/s13300-020-00765-6. Epub 2020 Jan 29."},{"pmid":"31758520","type":"DERIVED","citation":"Ishii H, Onishi Y, Oura T, Takeuchi M. Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study. Diabetes Ther. 2020 Jan;11(1):133-145. doi: 10.1007/s13300-019-00726-8. Epub 2019 Nov 22."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"After 16 weeks of the primary double-blind treatment period, participants taking placebo were switched to dulaglutide for an additional 36 weeks of open-label extension treatment. Efficacy was assessed for 16 weeks based on hypoglycemic agent evaluation.","groups":[{"id":"FG000","title":"Placebo","description":"Placebo administered subcutaneously (SC) once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 milligram (mg) administered SC once weekly for 36 weeks."},{"id":"FG001","title":"Dulaglutide","description":"Dulaglutide administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks."}],"periods":[{"title":"Double-Blind Treatment Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"120"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"120"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"117"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]},{"title":"Open-Label Extension Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"117"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"111"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Placebo","description":"Placebo administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks."},{"id":"BG001","title":"Dulaglutide","description":"Dulaglutide 0.75 mg administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"120"},{"groupId":"BG002","value":"159"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59.1","spread":"10.68"},{"groupId":"BG001","value":"59.3","spread":"10.23"},{"groupId":"BG002","value":"59.3","spread":"10.31"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"61"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"98"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"120"},{"groupId":"BG002","value":"159"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"120"},{"groupId":"BG002","value":"159"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"120"},{"groupId":"BG002","value":"159"}]}]}]},{"title":"Percentage of Hemoglobin A1c (HbA1c) at Baseline","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.64","spread":"0.72"},{"groupId":"BG001","value":"8.50","spread":"0.69"},{"groupId":"BG002","value":"8.53","spread":"0.70"}]}]}]},{"title":"Percentage of Participants with Insulin regimen","paramType":"NUMBER","unitOfMeasure":"percentage of insulin regimen","classes":[{"title":"Basal","categories":[{"measurements":[{"groupId":"BG000","value":"43.6"},{"groupId":"BG001","value":"43.3"},{"groupId":"BG002","value":"43.4"}]}]},{"title":"Premixed","categories":[{"measurements":[{"groupId":"BG000","value":"23.1"},{"groupId":"BG001","value":"21.7"},{"groupId":"BG002","value":"22.0"}]}]},{"title":"Basal/meal time","categories":[{"measurements":[{"groupId":"BG000","value":"33.3"},{"groupId":"BG001","value":"35.0"},{"groupId":"BG002","value":"34.6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, Week 16","groups":[{"id":"OG000","title":"Placebo","description":"Placebo administered SC for 16 weeks."},{"id":"OG001","title":"Dulaglutide","description":"Dulaglutide 0.75 mg administered SC once weekly for 16 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.099"},{"groupId":"OG001","value":"-1.45","spread":"0.057"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS mean percent difference","paramValue":"-1.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.73","ciUpperLimit":"-1.28"}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c <7.0% or ≤6.5%","description":"Percentage of participants whose HbA1c was \\<7.0% or ≤6.5%. 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