{"protocolSection":{"identificationModule":{"nctId":"NCT04591626","orgStudyIdInfo":{"id":"17731"},"secondaryIdInfos":[{"id":"H9X-MC-GBGO","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes","officialTitle":"A Randomized, Double-Blind Trial Comparing the Effect of the Addition of Dulaglutide 1.5 mg Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Patients With Type 2 Diabetes","acronym":"AWARD-CHN3"},"statusModule":{"statusVerifiedDate":"2023-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-12-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-04-28","type":"ACTUAL"},"completionDateStruct":{"date":"2022-04-28","type":"ACTUAL"},"studyFirstSubmitDate":"2020-10-16","studyFirstSubmitQcDate":"2020-10-16","studyFirstPostDateStruct":{"date":"2020-10-19","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-04-27","resultsFirstSubmitQcDate":"2023-04-27","resultsFirstPostDateStruct":{"date":"2023-05-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-04-27","lastUpdatePostDateStruct":{"date":"2023-05-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The main purpose of this study is to evaluate the safety and efficacy of once weekly dulaglutide when added to insulin glargine, with metformin and/or acarbose in Chinese participants with type 2 diabetes mellitus."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["T2DM","LY2189265"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":291,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1.5 Milligrams (mg) Dulaglutide","type":"EXPERIMENTAL","description":"Participants received 1.5 mg Dulaglutide administered once weekly (QW) subcutaneously (SC) as add-on to titrated treat-to-target (TTT) dose of Insulin Glargine given SC, along with metformin and/or acarbose.","interventionNames":["Drug: Dulaglutide","Drug: Insulin Glargine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.","interventionNames":["Drug: Placebo","Drug: Insulin Glargine"]}],"interventions":[{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["1.5 Milligrams (mg) Dulaglutide"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Insulin Glargine","description":"Administered SC","armGroupLabels":["1.5 Milligrams (mg) Dulaglutide","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. 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LS mean was determined using MMRM model with Baseline + OAM (metformin and/or acarbose) usage + HbA1c Group at Baseline + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 28"},{"measure":"Change From Baseline in Daily Mean Insulin Glargine Doses","description":"LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\\<8.5%, \\>=8.5%) + OAM use + Treatment + Visit + Treatment\\*Visit (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 28"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* have type 2 diabetes\n* are men or nonpregnant women aged ≥18 years at screening\n* have been treated with basal insulin glargine once daily and metformin and/or acarbose for at least 3 months prior to screening\n* doses of once daily insulin glargine and OAMs must be stable during the 3-month period prior to screening. Insulin glargine dose is considered stable when all doses during this period are within the range defined by ±20% of the most commonly used insulin glargine dose during this same period. Doses of metformin and/or acarbose are considered stable when doses are unchanged during the same period, and the doses should be in the inclusive range of the half maximum to maximum approved daily dose per the locally-approved label\n* have an HbA1c value ≥7.0% and ≤11.0% as assessed by the central laboratory at screening\n* require further insulin glargine dose increase at baseline per the TTT algorithm based on the SMBG data (FBG ≥5.6mmol/L) collected during the prior week\n* have stable weight (±5%) ≥3 months prior to screening\n* have body mass index (BMI) between ≥19.0 and ≤35.0 kg/m2 at screening\n\nExclusion Criteria:\n\n* have type 1 diabetes (T1D)\n* have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma\n* have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening\n* have had any of the following CV conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke)\n* have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone or plan to have a gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility\n* have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening\n* for participants on metformin or metformin and acarbose, have renal disease or renal dysfunction (eGFR \\[CKD-EPI\\] \\<45 mL/min/1.73 m2), as determined by the central laboratory; for participants on acarbose, have renal disease or renal dysfunction (eGFR \\[CKD-EPI\\] \\<25 mL/min/1.73 m2), as determined by the central laboratory\n* have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) syndrome in the absence of known C-cell hyperplasia (the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B syndrome have a known RET mutation and the potential participant for the study is negative for the RET mutation)\n* have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)\n* have serum calcitonin ≥20 pg/mL at screening, as determined by the central laboratory\n* have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease)\n* have been treated with any other antihyperglycemia regimen, other than basal insulin glargine once daily and metformin and/or acarbose, within the 3 months prior to screening or between screening and baseline","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - 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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":{"groups":[{"id":"FG000","title":"1.5 Milligrams (mg) Dulaglutide","description":"Participants received 1.5 mg Dulaglutide administered once weekly (QW) subcutaneously (SC) as add-on to titrated treat-to-target (TTT) dose of Insulin Glargine given SC, along with metformin and/or acarbose."},{"id":"FG001","title":"Placebo","description":"Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"144"},{"groupId":"FG001","numSubjects":"147"}]},{"type":"Received At Least One Dose of Study 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Drug","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose."},{"id":"BG001","title":"Placebo","description":"Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"144"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"291"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"144"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"291"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"57.80","spread":"9.33"},{"groupId":"BG001","value":"58.30","spread":"9.48"},{"groupId":"BG002","value":"58.10","spread":"9.39"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"144"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"291"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"109"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"90"},{"groupId":"BG002","value":"182"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"144"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"291"}]}],"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":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"144"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"291"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"144"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"291"}]}],"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":"144"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"291"}]},{"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 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HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.","populationDescription":"Participants with non-missing baseline value for HbA1c.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"136"},{"groupId":"BG001","value":"145"},{"groupId":"BG002","value":"281"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.60","spread":"1.00"},{"groupId":"BG001","value":"8.58","spread":"0.97"},{"groupId":"BG002","value":"8.59","spread":"0.98"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. 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