{"protocolSection":{"identificationModule":{"nctId":"NCT03730662","orgStudyIdInfo":{"id":"17072"},"secondaryIdInfos":[{"id":"I8F-MC-GPGM","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2018-002618-11","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) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk","officialTitle":"Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)","acronym":"SURPASS-4"},"statusModule":{"statusVerifiedDate":"2022-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-11-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-01-22","type":"ACTUAL"},"completionDateStruct":{"date":"2021-04-22","type":"ACTUAL"},"studyFirstSubmitDate":"2018-11-02","studyFirstSubmitQcDate":"2018-11-02","studyFirstPostDateStruct":{"date":"2018-11-05","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 purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["GIP","GLP-1","glucose metabolism disorders","metabolic diseases","endocrine system diseases","cardiovascular risk"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":2002,"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 Glargine","type":"ACTIVE_COMPARATOR","description":"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \\<100 mg/dL, following a treat-to-target (TTT) algorithm.","interventionNames":["Drug: Insulin Glargine"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC.","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Insulin Glargine","description":"Administered SC","armGroupLabels":["Insulin Glargine"]}]},"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 for post-baseline measures: Variable = Baseline + Pooled Country + Baseline sodium-glucose co-transporter-2 inhibitor (SGLT-2i) use Flag (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"}],"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. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants With HbA1c of <7.0%","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.","timeFrame":"Week 52"},{"measure":"Change From Baseline in Fasting Serum Glucose","description":"LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"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. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide","description":"Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide","timeFrame":"1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35"},{"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. Post-baseline comparisons between treatment and control group was evaluated using negative binomial model with variables : Number of episodes = Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable","timeFrame":"Baseline through Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nParticipants must:\n\n* Have been diagnosed with type 2 diabetes mellitus (T2DM)\n* Have HbA1c between ≥7.5% and ≤10.5%\n* Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening\n* Have increased risk for cardiovascular (CV) events\n* Be of stable weight (± 5%)\n* Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening\n\nExclusion Criteria\n\nParticipants must not:\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 immediate or urgent 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":"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. Epub 2023 Sep 5."},{"pmid":"37526908","type":"DERIVED","citation":"Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1."},{"pmid":"36152639","type":"DERIVED","citation":"Heerspink HJL, Sattar N, Pavo I, Haupt A, Duffin KL, Yang Z, Wiese RJ, Tuttle KR, Cherney DZI. Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: post-hoc analysis of an open-label, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Nov;10(11):774-785. doi: 10.1016/S2213-8587(22)00243-1. Epub 2022 Sep 21."},{"pmid":"35210595","type":"DERIVED","citation":"Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24."},{"pmid":"34672967","type":"DERIVED","citation":"Del Prato S, Kahn SE, Pavo I, Weerakkody GJ, Yang Z, Doupis J, Aizenberg D, Wynne AG, Riesmeyer JS, Heine RJ, Wiese RJ; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021 Nov 13;398(10313):1811-1824. doi: 10.1016/S0140-6736(21)02188-7. Epub 2021 Oct 18."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk","url":"https://trials.lillytrialguide.com/en-US/trial/740VpRcJPiyieyyWGYO2ao"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. 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LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug, excluding participants discontinuing study drug due to inadvertent enrollment","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (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":"Insulin Glargine","description":"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \\<100 mg/dL, following a treat-to-target (TTT) algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"261"},{"groupId":"OG002","value":"265"},{"groupId":"OG003","value":"784"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-58.4","spread":"1.65"},{"groupId":"OG001","value":"-61.1","spread":"1.66"},{"groupId":"OG002","value":"-66.1","spread":"1.66"},{"groupId":"OG003","value":"-46.1","spread":"0.96"}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide","description":"Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide","populationDescription":"Pharmacokinetic samples were collected from atleast the first 150 participants at each Tirzepatide dose, all participants aged ≥70 years, and all participants with severe renal impairment or end-stage renal disease (ESRD) (estimated glomerular filtration rate \\[eGFR\\] \\<30 mL/min)","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanograms per millilitre per hour","timeFrame":"1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"324"},{"groupId":"OG002","value":"334"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"81800","spread":"23.9"},{"groupId":"OG001","value":"165000","spread":"20.3"},{"groupId":"OG002","value":"246000","spread":"20.6"}]}]}]},{"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. Post-baseline comparisons between treatment and control group was evaluated using negative binomial model with variables : Number of episodes = Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable","populationDescription":"All randomized participants who received at least one dose of study drug, excluding participants hypoglycemic events occurring after initiation of a new antihyperglycemic therapy","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Episodes/participant/365.25 days","timeFrame":"Baseline through Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (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":"Insulin Glargine","description":"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \\<100 mg/dL, following a treat-to-target (TTT) algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"328"},{"groupId":"OG002","value":"338"},{"groupId":"OG003","value":"1000"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.10","spread":"0.023"},{"groupId":"OG001","value":"0.09","spread":"0.025"},{"groupId":"OG002","value":"0.11","spread":"0.030"},{"groupId":"OG003","value":"0.35","spread":"0.044"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline Up To 2 Years","description":"All 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":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.","deathsNumAffected":15,"deathsNumAtRisk":329,"seriousNumAffected":48,"seriousNumAtRisk":329,"otherNumAffected":112,"otherNumAtRisk":329},{"id":"EG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week.","deathsNumAffected":2,"deathsNumAtRisk":328,"seriousNumAffected":54,"seriousNumAtRisk":328,"otherNumAffected":158,"otherNumAtRisk":328},{"id":"EG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week.","deathsNumAffected":8,"deathsNumAtRisk":338,"seriousNumAffected":41,"seriousNumAtRisk":338,"otherNumAffected":184,"otherNumAtRisk":338},{"id":"EG003","title":"Insulin Glargine","description":"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \\<100 mg/dL, following a treat-to-target (TTT) algorithm.","deathsNumAffected":35,"deathsNumAtRisk":1000,"seriousNumAffected":193,"seriousNumAtRisk":1000,"otherNumAffected":192,"otherNumAtRisk":1000}],"seriousEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":329},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":328},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":338},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":1000}]},{"term":"Bicytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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