{"protocolSection":{"identificationModule":{"nctId":"NCT05691712","orgStudyIdInfo":{"id":"18552"},"secondaryIdInfos":[{"id":"I8F-MC-GPIM","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes","officialTitle":"A Randomized, Phase 3, Double Blind Trial Comparing the Effect of the Addition of Tirzepatide Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Participants With Type 2 Diabetes","acronym":"SURPASS-CN-INS"},"statusModule":{"statusVerifiedDate":"2025-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-02-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-07-01","type":"ACTUAL"},"completionDateStruct":{"date":"2024-07-01","type":"ACTUAL"},"studyFirstSubmitDate":"2023-01-11","studyFirstSubmitQcDate":"2023-01-11","studyFirstPostDateStruct":{"date":"2023-01-20","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-07-01","resultsFirstSubmitQcDate":"2025-07-21","resultsFirstPostDateStruct":{"date":"2025-08-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-07-21","lastUpdatePostDateStruct":{"date":"2025-08-08","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 compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes."},"conditionsModule":{"conditions":["Diabetes Type 2","Diabetes Mellitus","Glucose Metabolism Disorders","Metabolic Disease","Endocrine System Diseases"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":257,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 Milligram (mg) Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose injection pen (SDP) once weekly (QW) for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.","interventionNames":["Drug: Tirzepatide"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.","interventionNames":["Drug: Tirzepatide"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 Milligram (mg) Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","timeFrame":"Baseline, Week 40"}],"secondaryOutcomes":[{"measure":"Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using MMRM for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","timeFrame":"Baseline, Week 40"},{"measure":"Mean Change From Baseline in Body Weight","description":"LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\\<=8.0%, \\>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of Participants with HbA1c \\<7.0% (53 millimole/mole \\[mmol/mol\\]) and ≤6.5% (48 mmol/mol) is reported here.","timeFrame":"Week 40"},{"measure":"Mean Change From Baseline in Fasting Serum Glucose","description":"LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\\<=8.0%, \\>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \\<5.7% (39 mmol/Mol) is reported here.","timeFrame":"Week 40"},{"measure":"Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \\<5.7% (39 mmol/Mol) is reported here.","timeFrame":"Week 40"},{"measure":"Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles","description":"The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\\<=8.0%, \\>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5% is reported here.","timeFrame":"Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥10%","description":"Percentage of Participants who Achieved Weight Loss ≥10% is reported here.","timeFrame":"Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥15%","description":"Percentage of Participants who Achieved Weight Loss ≥15% is reported here.","timeFrame":"Week 40"},{"measure":"Percent Change From Baseline in Daily Mean Insulin Glargine Dose","description":"LS Mean was calculated using MMRM for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c (\\<=8.0%, \\>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants With HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL])","description":"Percentage of Participants with HbA1c \\<7.0%, Without Weight Gain (\\<0.1 Kilogram \\[kg\\]) and Without Hypoglycemia, (Blood Glucose \\<3.0 mmol/L \\<54 Milligram/Deciliter \\[mg/dL\\]) is reported here","timeFrame":"Week 40"},{"measure":"Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.0 mmol/L [54 mg/dL])","description":"Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain \\<0.1 kg and Without Hypoglycemia (Blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) is reported here.","timeFrame":"Week 40"},{"measure":"Percentage of Participants With HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)","description":"Percentage of Participants with HbA1c \\<7.0%, Without Weight Gain \\<0.1 kg and Without Hypoglycemia (Blood Glucose \\<3.9 mmol/L \\[70 mg/dL\\] or Severe Hypoglycemia) is reported here.","timeFrame":"Week 40"},{"measure":"Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)","description":"Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain \\<0.1 kg and Without Hypoglycemia (Blood glucose \\<3.9 mmol/L \\[70 mg/dL\\] or Severe Hypoglycemia) is reported here.","timeFrame":"Week 40"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have type 2 diabetes mellitus (T2DM)\n* Have HbA1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol)\n* Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days\n* Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²)\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus (T1DM)\n* Have a history of chronic or acute pancreatitis\n* Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment\n* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2\n* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months\n* Have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months\n* Have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF) in the past 2 months\n* Have a serum calcitonin level of ≥35 ng/L, as determined by central laboratory\n* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \\>3.0 times the upper limit of normal (ULN), as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial only if their ALT level is ≤3.0 times ULN.","healthyVolunteers":true,"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 - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"The Second People's Hospital of Hefei","city":"Hefei","state":"Anhui","zip":"230011","country":"China","geoPoint":{"lat":31.86389,"lon":117.28083}},{"facility":"Beijing Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100005","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Beijing Pinggu District Hospital","city":"Beijing","state":"Beijing Municipality","zip":"101200","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Chongqing General Hospital","city":"Chongqing","state":"Chongqing Municipality","zip":"400014","country":"China","geoPoint":{"lat":29.56026,"lon":106.55771}},{"facility":"Huizhou Municipal Central Hospital","city":"Huizhou","state":"Guangdong","zip":"516001","country":"China","geoPoint":{"lat":23.11147,"lon":114.41523}},{"facility":"The First Hospital of Harbin Medical University","city":"Harbin","state":"Heilongjiang","zip":"150001","country":"China","geoPoint":{"lat":45.75,"lon":126.65}},{"facility":"The Fourth Hospital of Harbin Medical University","city":"Harbin","state":"Heilongjiang","zip":"150001","country":"China","geoPoint":{"lat":45.75,"lon":126.65}},{"facility":"The First Affiliated Hospital of Henan University of Science &Technology","city":"LuoyangShi","state":"Henan","zip":"471003","country":"China"},{"facility":"The Second Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","zip":"450014","country":"China","geoPoint":{"lat":34.75778,"lon":113.64861}},{"facility":"The First People's Hospital of Yueyang","city":"Yueyang","state":"Hunan","zip":"414000","country":"China","geoPoint":{"lat":29.37455,"lon":113.09481}},{"facility":"Baotou Central Hospital","city":"Baotou","state":"Inner Mongolia","zip":"014040","country":"China","geoPoint":{"lat":40.6516,"lon":109.84389}},{"facility":"Changzhou No.2 People's Hospital","city":"Changzhou","state":"Jiangsu","zip":"213000","country":"China","geoPoint":{"lat":31.77359,"lon":119.95401}},{"facility":"Nanjing First Hospital","city":"Nanjing","state":"Jiangsu","zip":"210006","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"Zhongda Hospital Southeast University","city":"Nanjing","state":"Jiangsu","zip":"210009","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"The Second Affiliated Hospital of Nanjing Medical University","city":"Nanjing","state":"Jiangsu","zip":"210011","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"Wuxi People's Hospital","city":"Wuxi","state":"Jiangsu","zip":"214023","country":"China","geoPoint":{"lat":31.56887,"lon":120.28857}},{"facility":"The Affiliated Jiangyin Hospital of Southeast University Medical College","city":"WuxiShi","state":"Jiangsu","zip":"214400","country":"China"},{"facility":"Affiliated Hospital of Jiangsu University","city":"Zhenjiang","state":"Jiangsu","zip":"212000","country":"China","geoPoint":{"lat":32.21086,"lon":119.45508}},{"facility":"The Third Hospital of Nanchang","city":"Nanchang","state":"Jiangxi","zip":"330009","country":"China","geoPoint":{"lat":28.68396,"lon":115.85306}},{"facility":"The First Affiliated Hospital of Xi'an Medical University","city":"Xi'an","state":"Shaanxi","zip":"710077","country":"China","geoPoint":{"lat":34.25833,"lon":108.92861}},{"facility":"Jinan Central Hospital","city":"Jinan","state":"Shandong","zip":"250013","country":"China","geoPoint":{"lat":36.66833,"lon":116.99722}},{"facility":"West China Hospital of Sichuan University","city":"Chengdu","state":"Sichuan","zip":"610041","country":"China","geoPoint":{"lat":30.66667,"lon":104.06667}},{"facility":"Chengdu Fifth People's Hospital","city":"Chengdu","state":"Sichuan","zip":"611130","country":"China","geoPoint":{"lat":30.66667,"lon":104.06667}},{"facility":"Tianjin Medical University General Hospital","city":"Tianjin","state":"Tianjin Municipality","zip":"300052","country":"China","geoPoint":{"lat":39.14222,"lon":117.17667}},{"facility":"Huzhou Central Hospital","city":"Huzhou","state":"Zhejiang","zip":"313000","country":"China","geoPoint":{"lat":30.8703,"lon":120.0933}}]},"referencesModule":{"references":[{"pmid":"41167231","type":"DERIVED","citation":"Guo L, Dong X, Ma J, Liu M, Lu Y, Wang H, Li Q, Li L, Deng Y, Xu J. Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Dec;13(12):1015-1029. doi: 10.1016/S2213-8587(25)00248-7. Epub 2025 Oct 27."}]},"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":"ata are available 6 months after the primary publication and approval of the indication studied in the US and European Union (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":{"groups":[{"id":"FG000","title":"5 Milligram (mg) Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"FG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"FG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"FG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"65"},{"groupId":"FG001","numSubjects":"65"},{"groupId":"FG002","numSubjects":"63"},{"groupId":"FG003","numSubjects":"64"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"65"},{"groupId":"FG001","numSubjects":"65"},{"groupId":"FG002","numSubjects":"63"},{"groupId":"FG003","numSubjects":"64"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"60"},{"groupId":"FG002","numSubjects":"58"},{"groupId":"FG003","numSubjects":"61"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Assigned Treatment by Mistake","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"BG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"BG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"BG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"65"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"64"},{"groupId":"BG004","value":"257"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.10","spread":"9.97"},{"groupId":"BG001","value":"55.00","spread":"11.58"},{"groupId":"BG002","value":"55.80","spread":"10.11"},{"groupId":"BG003","value":"58.00","spread":"10.24"},{"groupId":"BG004","value":"56.70","spread":"10.53"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"26"},{"groupId":"BG003","value":"25"},{"groupId":"BG004","value":"99"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"39"},{"groupId":"BG004","value":"158"}]}]}]},{"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"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"65"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"64"},{"groupId":"BG004","value":"257"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","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"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"65"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"64"},{"groupId":"BG004","value":"257"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"65"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"64"},{"groupId":"BG004","value":"257"}]}]}]},{"title":"Percentage of Hemoglobin A1c (HbA1c) at Baseline","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.64","spread":"0.95"},{"groupId":"BG001","value":"8.60","spread":"1.09"},{"groupId":"BG002","value":"8.75","spread":"0.99"},{"groupId":"BG003","value":"8.84","spread":"0.99"},{"groupId":"BG004","value":"8.71","spread":"1.01"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per mole (mmol/mol)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG002","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-26.1","spread":"1.367"},{"groupId":"OG001","value":"-25.9","spread":"1.386"},{"groupId":"OG002","value":"-9.96","spread":"1.340"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-16.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-19.9","ciUpperLimit":"-12.36"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-15.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-19.7","ciUpperLimit":"-12.10"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using MMRM for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/mol","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-23.0","spread":"1.329"},{"groupId":"OG001","value":"-9.96","spread":"1.340"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-13.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.8","ciUpperLimit":"-9.34"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Body Weight","description":"LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\\<=8.0%, \\>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms (kg)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.7","spread":"0.52"},{"groupId":"OG001","value":"-4.8","spread":"0.54"},{"groupId":"OG002","value":"-4.3","spread":"0.55"},{"groupId":"OG003","value":"1.7","spread":"0.53"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-4.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.8","ciUpperLimit":"-2.9"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-6.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.0","ciUpperLimit":"-5.0"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-6.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.5","ciUpperLimit":"-4.5"}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of Participants with HbA1c \\<7.0% (53 millimole/mole \\[mmol/mol\\]) and ≤6.5% (48 mmol/mol) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"title":"HbA1c <7.0%","categories":[{"measurements":[{"groupId":"OG000","value":"75.81"},{"groupId":"OG001","value":"78.95"},{"groupId":"OG002","value":"78.18"},{"groupId":"OG003","value":"17.24"}]}]},{"title":"HbA1c ≤6.5%","categories":[{"measurements":[{"groupId":"OG000","value":"59.68"},{"groupId":"OG001","value":"77.19"},{"groupId":"OG002","value":"69.09"},{"groupId":"OG003","value":"6.90"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Fasting Serum Glucose","description":"LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\\<=8.0%, \\>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligram per deciliter (mg/dL)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-45.5","spread":"3.73"},{"groupId":"OG001","value":"-52.5","spread":"3.87"},{"groupId":"OG002","value":"-51.0","spread":"3.94"},{"groupId":"OG003","value":"-23.7","spread":"3.84"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-21.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-32.4","ciUpperLimit":"-11.3"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-28.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-39.6","ciUpperLimit":"-18.1"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-27.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-38.2","ciUpperLimit":"-16.5"}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \\<5.7% (39 mmol/Mol) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG002","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17.54"},{"groupId":"OG001","value":"25.45"},{"groupId":"OG002","value":"0.00"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \\<5.7% (39 mmol/Mol) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.68"},{"groupId":"OG001","value":"0.00"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles","description":"The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\\<=8.0%, \\>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per liter per day(mmol/L/day)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"63"}]}],"classes":[{"title":"Morning Premeal - Fasting","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"57"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.62","spread":"0.127"},{"groupId":"OG001","value":"-2.53","spread":"0.132"},{"groupId":"OG002","value":"-2.80","spread":"0.136"},{"groupId":"OG003","value":"-2.22","spread":"0.131"}]}]},{"title":"Morning 2-hour Postmeal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"51"},{"groupId":"OG003","value":"55"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.78","spread":"0.300"},{"groupId":"OG001","value":"-5.34","spread":"0.306"},{"groupId":"OG002","value":"-5.05","spread":"0.313"},{"groupId":"OG003","value":"-2.57","spread":"0.300"}]}]},{"title":"Midday Premeal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"57"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.87","spread":"0.247"},{"groupId":"OG001","value":"-3.52","spread":"0.258"},{"groupId":"OG002","value":"-3.26","spread":"0.263"},{"groupId":"OG003","value":"-1.32","spread":"0.253"}]}]},{"title":"Midday 2-hour Postmeal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"51"},{"groupId":"OG003","value":"55"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.05","spread":"0.318"},{"groupId":"OG001","value":"-4.10","spread":"0.325"},{"groupId":"OG002","value":"-3.65","spread":"0.335"},{"groupId":"OG003","value":"-1.46","spread":"0.322"}]}]},{"title":"Evening Premeal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"63"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.84","spread":"0.264"},{"groupId":"OG001","value":"-3.64","spread":"0.276"},{"groupId":"OG002","value":"-3.20","spread":"0.285"},{"groupId":"OG003","value":"-0.95","spread":"0.271"}]}]},{"title":"Evening 2-hour Postmeal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"54"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.97","spread":"0.347"},{"groupId":"OG001","value":"-4.52","spread":"0.351"},{"groupId":"OG002","value":"-4.42","spread":"0.367"},{"groupId":"OG003","value":"-1.47","spread":"0.346"}]}]},{"title":"Bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"52"},{"groupId":"OG003","value":"54"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.41","spread":"0.287"},{"groupId":"OG001","value":"-4.19","spread":"0.297"},{"groupId":"OG002","value":"-3.85","spread":"0.307"},{"groupId":"OG003","value":"-1.71","spread":"0.298"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5% is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25.81"},{"groupId":"OG001","value":"49.12"},{"groupId":"OG002","value":"60.00"},{"groupId":"OG003","value":"1.72"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥10%","description":"Percentage of Participants who Achieved Weight Loss ≥10% is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.06"},{"groupId":"OG001","value":"21.05"},{"groupId":"OG002","value":"25.45"},{"groupId":"OG003","value":"0.00"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥15%","description":"Percentage of Participants who Achieved Weight Loss ≥15% is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.84"},{"groupId":"OG001","value":"5.26"},{"groupId":"OG002","value":"9.09"},{"groupId":"OG003","value":"0.00"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Daily Mean Insulin Glargine Dose","description":"LS Mean was calculated using MMRM for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c (\\<=8.0%, \\>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.90","spread":"6.424"},{"groupId":"OG001","value":"21.95","spread":"6.471"},{"groupId":"OG002","value":"18.21","spread":"6.364"},{"groupId":"OG003","value":"69.28","spread":"8.826"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL])","description":"Percentage of Participants with HbA1c \\<7.0%, Without Weight Gain (\\<0.1 Kilogram \\[kg\\]) and Without Hypoglycemia, (Blood Glucose \\<3.0 mmol/L \\<54 Milligram/Deciliter \\[mg/dL\\]) is reported here","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"59.68"},{"groupId":"OG001","value":"70.18"},{"groupId":"OG002","value":"67.27"},{"groupId":"OG003","value":"5.17"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.0 mmol/L [54 mg/dL])","description":"Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain \\<0.1 kg and Without Hypoglycemia (Blood glucose \\<3.0 mmol/L \\[54 mg/dL\\]) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"46.77"},{"groupId":"OG001","value":"70.18"},{"groupId":"OG002","value":"61.82"},{"groupId":"OG003","value":"1.72"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)","description":"Percentage of Participants with HbA1c \\<7.0%, Without Weight Gain \\<0.1 kg and Without Hypoglycemia (Blood Glucose \\<3.9 mmol/L \\[70 mg/dL\\] or Severe Hypoglycemia) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.61"},{"groupId":"OG001","value":"57.89"},{"groupId":"OG002","value":"47.27"},{"groupId":"OG003","value":"5.17"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)","description":"Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain \\<0.1 kg and Without Hypoglycemia (Blood glucose \\<3.9 mmol/L \\[70 mg/dL\\] or Severe Hypoglycemia) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.71"},{"groupId":"OG001","value":"57.89"},{"groupId":"OG002","value":"43.64"},{"groupId":"OG003","value":"1.72"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline up to week 44","description":"All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. 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Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.","eventGroups":[{"id":"EG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.","deathsNumAffected":1,"deathsNumAtRisk":65,"seriousNumAffected":8,"seriousNumAtRisk":65,"otherNumAffected":45,"otherNumAtRisk":65},{"id":"EG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was 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disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":64}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":64}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":64}]},{"term":"Eye disorder","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":64}]},{"term":"Retinal detachment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 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27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":64}]},{"term":"Gastrointestinal disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":63},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":64}]},{"term":"Large intestine perforation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":64}]},{"term":"Large intestine polyp","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":63},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":64}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":64}]},{"term":"Mass","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":63},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":64}]},{"term":"Oedema peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":64}]},{"term":"Sudden death","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":64}]},{"term":"Otitis media","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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