{"protocolSection":{"identificationModule":{"nctId":"NCT04537923","orgStudyIdInfo":{"id":"17204"},"secondaryIdInfos":[{"id":"I8F-MC-GPHD","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2020-000284-23","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin","officialTitle":"A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)","acronym":"SURPASS-6"},"statusModule":{"statusVerifiedDate":"2023-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-10-19","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-10-11","type":"ACTUAL"},"completionDateStruct":{"date":"2022-11-01","type":"ACTUAL"},"studyFirstSubmitDate":"2020-09-02","studyFirstSubmitQcDate":"2020-09-02","studyFirstPostDateStruct":{"date":"2020-09-03","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-10-10","resultsFirstSubmitQcDate":"2023-10-10","resultsFirstPostDateStruct":{"date":"2023-11-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-10-10","lastUpdatePostDateStruct":{"date":"2023-11-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["glucose-dependent insulinotropic polypeptide (GIP)","glucagon-like peptide-1 (GLP-1)","GIP/GLP-1 dual receptor agonist","T2DM"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1428,"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":"Insulin Lispro","type":"ACTIVE_COMPARATOR","description":"Insulin lispro 100 units per milliliter (U100) administered SC three times a day.","interventionNames":["Drug: Insulin Lispro (U100)"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Insulin Lispro (U100)","description":"Administered SC","armGroupLabels":["Insulin Lispro"],"otherNames":["LY275585"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 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 covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c","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 determined by MMRM model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants With HbA1c Target Values <7.0%","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.","timeFrame":"Week 52"},{"measure":"Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Fasting Serum Glucose","description":"LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"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 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 determined by MMRM model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia","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 52"},{"measure":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5% is reported here.","timeFrame":"Week 52"},{"measure":"Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score","description":"The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. PCS score is reported here. PCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by analysis of covariance (ANCOVA) model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score","description":"The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. MCS score is reported here. MCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by ANCOVA model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares).","timeFrame":"Baseline, Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have been diagnosed with type 2 diabetes mellitus (T2DM)\n* Have HbA1c between ≥7.5% and ≤11%\n* Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors\n* Be of stable weight (± 5%) for at least 90 days\n* Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 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 macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment\n* Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility\n* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months\n* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2\n* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months\n* Have an estimated glomerular filtration rate \\<30 mL/minute/1.73 m² \\[for participants on metformin, estimated glomerular filtration rate \\<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\\]","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - 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(OR)","paramValue":"6.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.27","ciUpperLimit":"8.88"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"7.94","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.37","ciUpperLimit":"11.75"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing 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 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Insulin Lispro","description":"Participants received Insulin lispro (U100) administered SC three times a day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"234"},{"groupId":"OG002","value":"233"},{"groupId":"OG003","value":"694"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.9","spread":"0.37"},{"groupId":"OG001","value":"-9.9","spread":"0.37"},{"groupId":"OG002","value":"-12.0","spread":"0.38"},{"groupId":"OG003","value":"3.8","spread":"0.22"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-10.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.5","ciUpperLimit":"-9.9"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-13.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.5","ciUpperLimit":"-12.9"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-15.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.7","ciUpperLimit":"-15.0"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose","description":"LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing 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 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Insulin Lispro","description":"Participants received Insulin lispro (U100) administered SC three times a day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"235"},{"groupId":"OG002","value":"233"},{"groupId":"OG003","value":"694"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-33.2","spread":"3.28"},{"groupId":"OG001","value":"-43.0","spread":"3.32"},{"groupId":"OG002","value":"-41.6","spread":"3.42"},{"groupId":"OG003","value":"-10.0","spread":"1.99"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-23.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-30.8","ciUpperLimit":"-15.7"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-33.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-40.6","ciUpperLimit":"-25.4"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-31.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-39.3","ciUpperLimit":"-23.8"}]},{"type":"SECONDARY","title":"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 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 determined by MMRM model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing 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/day","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Insulin Lispro","description":"Participants received Insulin lispro (U100) administered SC three times a day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"219"},{"groupId":"OG001","value":"210"},{"groupId":"OG002","value":"204"},{"groupId":"OG003","value":"574"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-56.7","spread":"1.80"},{"groupId":"OG001","value":"-61.5","spread":"1.85"},{"groupId":"OG002","value":"67.6","spread":"1.86"},{"groupId":"OG003","value":"-55.8","spread":"1.13"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.682","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.0","ciUpperLimit":"3.3"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.010","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-5.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.9","ciUpperLimit":"-1.4"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-11.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.0","ciUpperLimit":"-7.5"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia","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 randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants 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 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Insulin Lispro","description":"Participants received Insulin lispro (U100) administered SC three times a day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"234"},{"groupId":"OG002","value":"233"},{"groupId":"OG003","value":"692"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.70"},{"groupId":"OG001","value":"70.05"},{"groupId":"OG002","value":"75.12"},{"groupId":"OG003","value":"13.41"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"8.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.66","ciUpperLimit":"11.83"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"16.90","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"11.44","ciUpperLimit":"24.96"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"21.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"14.49","ciUpperLimit":"32.93"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5% is reported here.","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants 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 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Insulin Lispro","description":"Participants received Insulin lispro (U100) administered SC three times a day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"238"},{"groupId":"OG002","value":"236"},{"groupId":"OG003","value":"708"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"64.19"},{"groupId":"OG001","value":"79.21"},{"groupId":"OG002","value":"83.15"},{"groupId":"OG003","value":"6.34"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"28.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"18.36","ciUpperLimit":"43.46"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"58.90","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"36.76","ciUpperLimit":"94.39"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"77.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"47.49","ciUpperLimit":"127.33"}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score","description":"The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. PCS score is reported here. PCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by analysis of covariance (ANCOVA) model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing 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":"score on a scale","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Insulin Lispro","description":"Participants received Insulin lispro (U100) administered SC three times a day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"217"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"599"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"0.46"},{"groupId":"OG001","value":"1.7","spread":"0.46"},{"groupId":"OG002","value":"1.7","spread":"0.48"},{"groupId":"OG003","value":"-0.6","spread":"0.28"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.005","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"1.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.5","ciUpperLimit":"2.6"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.2","ciUpperLimit":"3.3"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.2","ciUpperLimit":"3.3"}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score","description":"The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. MCS score is reported here. MCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by ANCOVA model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing 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":"score on a scale","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Insulin Lispro","description":"Participants received Insulin lispro (U100) administered SC three times a day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"217"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"599"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"0.59"},{"groupId":"OG001","value":"1.5","spread":"0.59"},{"groupId":"OG002","value":"0.7","spread":"0.62"},{"groupId":"OG003","value":"-1.3","spread":"0.36"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.020","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"1.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.3","ciUpperLimit":"2.9"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.5","ciUpperLimit":"4.2"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.004","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.7","ciUpperLimit":"3.5"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline up to week 56","description":"All randomized participants who received at least one dose of study drug. 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 tirzepatide administered SC once a week.","deathsNumAffected":3,"deathsNumAtRisk":243,"seriousNumAffected":20,"seriousNumAtRisk":243,"otherNumAffected":94,"otherNumAtRisk":243},{"id":"EG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once a week.","deathsNumAffected":3,"deathsNumAtRisk":238,"seriousNumAffected":16,"seriousNumAtRisk":238,"otherNumAffected":116,"otherNumAtRisk":238},{"id":"EG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once a week.","deathsNumAffected":1,"deathsNumAtRisk":236,"seriousNumAffected":17,"seriousNumAtRisk":236,"otherNumAffected":121,"otherNumAtRisk":236},{"id":"EG003","title":"Insulin Lispro","description":"Participants received Insulin lispro (U100) administered SC three times a day.","deathsNumAffected":11,"deathsNumAtRisk":708,"seriousNumAffected":81,"seriousNumAtRisk":708,"otherNumAffected":99,"otherNumAtRisk":708}],"seriousEvents":[{"term":"Iron deficiency anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":243},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":238},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":236},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":708}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":243},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":238},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":236},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":708}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":243},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":238},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":236},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":708}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":243},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":238},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":236},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":708}]},{"term":"Arteriosclerosis coronary artery","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":243},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":238},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":236},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":708}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":243},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":238},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":236},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":708}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":243},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":238},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":236},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":708}]},{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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