{"protocolSection":{"identificationModule":{"nctId":"NCT03987919","orgStudyIdInfo":{"id":"17001"},"secondaryIdInfos":[{"id":"I8F-MC-GPGL","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2018-004422-29","type":"EUDRACT_NUMBER"},{"id":"2018","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2018"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes","officialTitle":"A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes","acronym":"SURPASS-2"},"statusModule":{"statusVerifiedDate":"2021-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-07-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-01-28","type":"ACTUAL"},"completionDateStruct":{"date":"2021-02-15","type":"ACTUAL"},"studyFirstSubmitDate":"2019-06-14","studyFirstSubmitQcDate":"2019-06-14","studyFirstPostDateStruct":{"date":"2019-06-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-01-21","resultsFirstSubmitQcDate":"2022-01-21","resultsFirstPostDateStruct":{"date":"2022-02-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-01-21","lastUpdatePostDateStruct":{"date":"2022-02-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["T2DM","GLP-1 RA","Glucose-dependent insulinotropic polypeptide (GIP)","glucagon-like peptide-1 (GLP-1)","GIP/GLP-1 dual receptor agonist"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1879,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"10 mg tirzepatide administered SC once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"15 mg tirzepatide administered SC once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"1 mg Semaglutide","type":"ACTIVE_COMPARATOR","description":"1 mg semaglutide administered SC once a week.","interventionNames":["Drug: Semaglutide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Semaglutide","description":"Administered SC","armGroupLabels":["1 mg Semaglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 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 determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c (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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Change From Baseline in Body Weight","description":"Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants Achieving an HbA1c Target Value of <7%","description":"Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.","timeFrame":"Week 40"},{"measure":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5%.","timeFrame":"Week 40"},{"measure":"Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score","description":"DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS Mean was determined by ANCOVA with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia","description":"The hypoglycemia events were defined by participant reported events with blood glucose \\<54mg/dL) (\\<3.0 mmol/L\\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment.","timeFrame":"Baseline through Safety Follow-Up (Up to Week 44)"},{"measure":"Percentage of Participants Achieving an HbA1c Target Value of <5.7%","description":"Percentage of Participants Achieving an HbA1c Target Value of \\<5.7%.","timeFrame":"Week 40"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have been diagnosed with type 2 diabetes mellitus (T2DM)\n* Have HbA1c between ≥7.0% and ≤10.5%\n* Be on stable treatment with unchanged dose of metformin \\>1500 mg/day for at least 3 months prior to screening\n* Be of stable weight (±5%) for at least 3 months before screening\n* Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus\n* Have had chronic or acute pancreatitis any time prior to study entry\n* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment\n* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss\n* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \\>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. 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Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12."},{"pmid":"38777128","type":"DERIVED","citation":"Osumili B, Fan L, Paik JS, Pantalone KM, Ranta K, Sapin H, Tofe S. Tirzepatide 5, 10 and 15 mg versus injectable semaglutide 0.5 mg for the treatment of type 2 diabetes: An adjusted indirect treatment comparison. Diabetes Res Clin Pract. 2024 Jun;212:111717. doi: 10.1016/j.diabres.2024.111717. Epub 2024 May 21."},{"pmid":"37668888","type":"DERIVED","citation":"Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. 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Time to Reach Glycaemic and Body Weight Loss Thresholds with Tirzepatide in Patients with Type 2 Diabetes: A Pre-planned Exploratory Analysis of SURPASS-2 and SURPASS-3. Diabetes Ther. 2023 May;14(5):925-936. doi: 10.1007/s13300-023-01398-1. Epub 2023 Mar 31."},{"pmid":"35489606","type":"DERIVED","citation":"Ten Doesschate T, van der Vaart TW, Debisarun PA, Taks E, Moorlag SJCFM, Paternotte N, Boersma WG, Kuiper VP, Roukens AHE, Rijnders BJA, Voss A, Veerman KM, Kerckhoffs APM, Oever JT, van Crevel R, van Nieuwkoop C, Lalmohamed A, van de Wijgert JHHM, Netea MG, Bonten MJM, van Werkhoven CH. Bacillus Calmette-Guerin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial. Clin Microbiol Infect. 2022 Sep;28(9):1278-1285. doi: 10.1016/j.cmi.2022.04.009. Epub 2022 Apr 28."},{"pmid":"35210595","type":"DERIVED","citation":"Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. 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Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"1 mg Semaglutide","description":"1 mg semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"461"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.09","spread":"0.047"},{"groupId":"OG001","value":"-1.86","spread":"0.048"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"-0.10"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline body weight value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilograms (kg)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"1 mg Semaglutide","description":"1 mg of semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"459"},{"groupId":"OG002","value":"464"},{"groupId":"OG003","value":"462"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.8","spread":"0.33"},{"groupId":"OG001","value":"-10.3","spread":"0.34"},{"groupId":"OG002","value":"-12.4","spread":"0.34"},{"groupId":"OG003","value":"-6.2","spread":"0.33"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.6","ciUpperLimit":"-0.7"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-4.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.0","ciUpperLimit":"-3.2"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-6.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.1","ciUpperLimit":"-5.3"}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving an HbA1c Target Value of <7%","description":"Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"1 mg Semaglutide","description":"1 mg semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"459"},{"groupId":"OG002","value":"464"},{"groupId":"OG003","value":"461"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"85.47"},{"groupId":"OG001","value":"88.89"},{"groupId":"OG002","value":"92.24"},{"groupId":"OG003","value":"81.13"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.023","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.06","ciUpperLimit":"2.23"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.44","ciUpperLimit":"3.17"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.97","ciUpperLimit":"4.66"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline FSG value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","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":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"1 mg Semaglutide","description":"1 mg semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"458"},{"groupId":"OG002","value":"464"},{"groupId":"OG003","value":"459"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-56.0","spread":"1.57"},{"groupId":"OG001","value":"-61.6","spread":"1.60"},{"groupId":"OG002","value":"-63.4","spread":"1.59"},{"groupId":"OG003","value":"-48.6","spread":"1.58"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-7.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.7","ciUpperLimit":"-3.0"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-13.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.4","ciUpperLimit":"-8.6"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-14.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-19.1","ciUpperLimit":"-10.3"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline SMBG value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"1 mg Semaglutide","description":"1 mg of semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"424"},{"groupId":"OG001","value":"412"},{"groupId":"OG002","value":"413"},{"groupId":"OG003","value":"414"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-65.4","spread":"1.04"},{"groupId":"OG001","value":"-70.6","spread":"1.05"},{"groupId":"OG002","value":"-74.3","spread":"1.05"},{"groupId":"OG003","value":"-61.4","spread":"1.04"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5%.","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline weight loss, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"1 mg Semaglutide","description":"1 mg of semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"459"},{"groupId":"OG002","value":"464"},{"groupId":"OG003","value":"462"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"68.55"},{"groupId":"OG001","value":"82.35"},{"groupId":"OG002","value":"86.21"},{"groupId":"OG003","value":"58.44"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.20","ciUpperLimit":"2.08"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.57","ciUpperLimit":"4.75"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.60","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.32","ciUpperLimit":"6.38"}]},{"type":"SECONDARY","title":"Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score","description":"DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS Mean was determined by ANCOVA with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug. Last observation carried forward (LOCF) endpoint only carries forward the last non-baseline observations before rescue therapy or stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"1 mg Semaglutide","description":"1 mg of semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"399"},{"groupId":"OG002","value":"398"},{"groupId":"OG003","value":"412"}]}],"classes":[{"title":"Hyperglycemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"418"},{"groupId":"OG001","value":"399"},{"groupId":"OG002","value":"398"},{"groupId":"OG003","value":"411"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"0.10"},{"groupId":"OG001","value":"-1.4","spread":"0.10"},{"groupId":"OG002","value":"-1.5","spread":"0.10"},{"groupId":"OG003","value":"-1.1","spread":"0.10"}]}]},{"title":"Hypoglycemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"416"},{"groupId":"OG001","value":"398"},{"groupId":"OG002","value":"398"},{"groupId":"OG003","value":"412"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"0.10"},{"groupId":"OG001","value":"-0.7","spread":"0.10"},{"groupId":"OG002","value":"-0.8","spread":"0.10"},{"groupId":"OG003","value":"-0.7","spread":"0.10"}]}]},{"title":"Total Score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"399"},{"groupId":"OG002","value":"398"},{"groupId":"OG003","value":"411"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"15.7","spread":"0.18"},{"groupId":"OG001","value":"15.6","spread":"0.19"},{"groupId":"OG002","value":"16.1","spread":"0.19"},{"groupId":"OG003","value":"15.8","spread":"0.19"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.084","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.03"},{"groupIds":["OG001","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.050","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"0.00"},{"groupIds":["OG002","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.005","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.66","ciUpperLimit":"-0.12"},{"groupIds":["OG000","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.688","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"0.22"},{"groupIds":["OG001","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.909","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.29","ciUpperLimit":"0.26"},{"groupIds":["OG002","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.358","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"0.15"},{"groupIds":["OG000","OG003"],"groupDescription":"Total Score","nonInferiorityType":"SUPERIORITY","pValue":"0.701","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"0.41"},{"groupIds":["OG001","OG003"],"groupDescription":"Total Score","nonInferiorityType":"SUPERIORITY","pValue":"0.341","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.78","ciUpperLimit":"0.27"},{"groupIds":["OG002","OG003"],"groupDescription":"Total Score","nonInferiorityType":"SUPERIORITY","pValue":"0.321","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.79"}]},{"type":"SECONDARY","title":"Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia","description":"The hypoglycemia events were defined by participant reported events with blood glucose \\<54mg/dL) (\\<3.0 mmol/L\\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Episodes/participant/365.25 days","timeFrame":"Baseline through Safety Follow-Up (Up to Week 44)","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"1 mg Semaglutide","description":"1 mg of semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"470"},{"groupId":"OG001","value":"469"},{"groupId":"OG002","value":"470"},{"groupId":"OG003","value":"469"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0102","spread":"0.00423"},{"groupId":"OG001","value":"0.0046","spread":"0.00488"},{"groupId":"OG002","value":"0.0202","spread":"0.00840"},{"groupId":"OG003","value":"0.0046","spread":"0.00340"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving an HbA1c Target Value of <5.7%","description":"Percentage of Participants Achieving an HbA1c Target Value of \\<5.7%.","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"1 mg Semaglutide","description":"1 mg of semaglutide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"459"},{"groupId":"OG002","value":"464"},{"groupId":"OG003","value":"461"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29.28"},{"groupId":"OG001","value":"44.66"},{"groupId":"OG002","value":"50.86"},{"groupId":"OG003","value":"19.74"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.35","ciUpperLimit":"2.57"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.94","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.88","ciUpperLimit":"5.39"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"5.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.73","ciUpperLimit":"6.97"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline, Safety follow-up (44 Weeks)","description":"All randomized participants who received at least one dose of study drug. 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