{"protocolSection":{"identificationModule":{"nctId":"NCT04093752","orgStudyIdInfo":{"id":"17210"},"secondaryIdInfos":[{"id":"I8F-MC-GPHO","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)","officialTitle":"A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea"},"statusModule":{"statusVerifiedDate":"2022-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-12-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-11-01","type":"ACTUAL"},"completionDateStruct":{"date":"2021-11-24","type":"ACTUAL"},"studyFirstSubmitDate":"2019-09-17","studyFirstSubmitQcDate":"2019-09-17","studyFirstPostDateStruct":{"date":"2019-09-18","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-10-27","resultsFirstSubmitQcDate":"2022-12-12","resultsFirstPostDateStruct":{"date":"2023-01-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-12-12","lastUpdatePostDateStruct":{"date":"2023-01-06","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 reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["T2DM"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":917,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).","interventionNames":["Drug: Tirzepatide"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 10 mg tirzepatide administered SC QW.","interventionNames":["Drug: Tirzepatide"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 15 mg tirzepatide administered SC QW.","interventionNames":["Drug: Tirzepatide"]},{"label":"Insulin Glargine","type":"ACTIVE_COMPARATOR","description":"Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (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":"Mean 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 covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"}],"secondaryOutcomes":[{"measure":"Mean 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 with covariates Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Mean Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\\<= 8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants Achieving an HbA1c Target Value of <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. Imputed data includes observed value and imputed value if endpoint measure is missing.","timeFrame":"Week 40"},{"measure":"Percentage of Participants Achieving an HbA1c Target Value of <5.7%","description":"HbA1c is the glycosylated fraction of hemoglobin A. Imputed data includes observed value and imputed value if endpoint measure is missing.","timeFrame":"Week 40"},{"measure":"Mean Change From Baseline in Fasting Serum Glucose","description":"Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\\<= 8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","timeFrame":"Baseline, Week 40"},{"measure":"Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values","description":"The SMBG data was 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. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\\<= 8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Imputed data includes observed value and imputed value if endpoint measure is missing.","timeFrame":"Week 40"},{"measure":"Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction 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 treatment satisfaction score 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 model for endpoint measures with Baseline + Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline OAM Use (Met, Met plus SU) + Treatment (Type III sum of squares) as covariates.","timeFrame":"Baseline, Week 40"},{"measure":"Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia","description":"The hypoglycemia events were defined by participant reported events with blood glucose \\< 54 mg/dL \\[\\<3.0 Millimole per Liter (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 post-baseline hypoglycemia was estimated by negative binomial model: Number of episodes = Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\\<= 8.5%, \\>8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.","timeFrame":"Baseline through end of safety follow-up (Up To Week 44)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months\n* Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use \\[≤14 consecutive days\\] for acute conditions)\n* HbA1c ≥7.5% to ≤11.0% at screening\n* Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment\n* Body mass Index (BMI) ≥23 kilograms per meter squared\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Have history of chronic or acute pancreatitis\n* Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment\n* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months\n* Have a history of ketoacidosis or hyperosmolar state/coma\n* Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility\n* Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months\n* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n* Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months","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 - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Paratus Clinical Research Western Sydney","city":"Blacktown","state":"New South Wales","zip":"2148","country":"Australia","geoPoint":{"lat":-33.76667,"lon":150.91667}},{"facility":"Paratus Clinical Research Central Coast","city":"Kanwal","state":"New South Wales","zip":"2259","country":"Australia","geoPoint":{"lat":-33.253,"lon":151.4911}},{"facility":"Holdsworth House Medical Practice","city":"Sydney","state":"New South Wales","zip":"2010","country":"Australia","geoPoint":{"lat":-33.86785,"lon":151.20732}},{"facility":"Illawarra Shoalhaven Local Health District","city":"Wollongong","state":"New South Wales","zip":"2500","country":"Australia","geoPoint":{"lat":-34.424,"lon":150.89345}},{"facility":"Core Research Group","city":"Milton","state":"Queensland","zip":"4064","country":"Australia","geoPoint":{"lat":-27.47039,"lon":153.00312}},{"facility":"Barwon Health - The Geelong Hospital","city":"Geelong","state":"Victoria","zip":"3220","country":"Australia","geoPoint":{"lat":-38.14711,"lon":144.36069}},{"facility":"Adelaide Medical Solutions","city":"Woodville South","zip":"5011","country":"Australia","geoPoint":{"lat":-34.88186,"lon":138.53477}},{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100044","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Huizhou Municipal Central Hospital","city":"Huizhou","state":"Guangdong","zip":"516001","country":"China","geoPoint":{"lat":23.11147,"lon":114.41523}},{"facility":"Cangzhou People's Hospital","city":"Cangzhou","state":"Hebei","zip":"061600","country":"China","geoPoint":{"lat":38.31124,"lon":116.85334}},{"facility":"Hebei Medical University","city":"Hengshui Shi","state":"Hebei","zip":"053000","country":"China"},{"facility":"The Fourth Affiliated 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":"Luoyang","state":"Henan","zip":"471003","country":"China","geoPoint":{"lat":34.67345,"lon":112.43684}},{"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":"Bao Tou 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":"213003","country":"China","geoPoint":{"lat":31.77359,"lon":119.95401}},{"facility":"Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School","city":"Nanjing","state":"Jiangsu","zip":"210000","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"The First Hospital of Nanjing","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":"Nanjing Medical University - Nanjing Jiangning Hospital","city":"Nanjing","state":"Jiangsu","zip":"211100","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"Suzhou Municipal Hospital","city":"Suzhou","state":"Jiangsu","zip":"215002","country":"China","geoPoint":{"lat":31.30408,"lon":120.59538}},{"facility":"The First Affiliated Hospital of Soochow University","city":"Suzhou","state":"Jiangsu","zip":"215066","country":"China","geoPoint":{"lat":31.30408,"lon":120.59538}},{"facility":"Wuxi People's Hospital","city":"Wuxi","state":"Jiangsu","zip":"214023","country":"China","geoPoint":{"lat":31.56887,"lon":120.28857}},{"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 Hospital of Jilin University","city":"Changchun","state":"Jilin","zip":"130021","country":"China","geoPoint":{"lat":43.88,"lon":125.32278}},{"facility":"Dalian University - The Affiliated Zhongshan Hospital","city":"Dalian","state":"Liaoning","zip":"116001","country":"China","geoPoint":{"lat":38.91222,"lon":121.60222}},{"facility":"Shengjing Hospital of China Medical University","city":"Shenyang","state":"Liaoning","zip":"110004","country":"China","geoPoint":{"lat":41.79222,"lon":123.43278}},{"facility":"First Affiliated Hospital of Xi'an Jiaotong University","city":"Xi'an","state":"Shaanxi","zip":"710061","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":"Qingdao Central Hospital","city":"Qingdao","state":"Shandong","zip":"266042","country":"China","geoPoint":{"lat":36.06488,"lon":120.38042}},{"facility":"Shanghai 6th people's hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"1st affiliated Hospital of Shanxi Medical University","city":"Taiyuan","state":"Shanxi","zip":"030001","country":"China","geoPoint":{"lat":37.86944,"lon":112.56028}},{"facility":"The First Affiliated Hospital of Xi'an Medical University","city":"Xi’an","state":"Shanxi","country":"China","geoPoint":{"lat":35.99785,"lon":113.52486}},{"facility":"West China Hospital 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":"Chongqing Three Gorges Central Hospital","city":"Wanzhou","state":"Wanzhou","zip":"404199","country":"China","geoPoint":{"lat":30.76451,"lon":108.39586}},{"facility":"Chongqing General Hospital","city":"Chongqing","state":"Yuzhong District","zip":"400014","country":"China","geoPoint":{"lat":29.56026,"lon":106.55771}},{"facility":"Huzhou Central Hospital","city":"Huzhou","state":"Zhejiang","zip":"313000","country":"China","geoPoint":{"lat":30.8703,"lon":120.0933}},{"facility":"Shaoxing People's Hospital","city":"Shaoxing","state":"Zhejiang","zip":"312000","country":"China","geoPoint":{"lat":30.00237,"lon":120.57864}},{"facility":"Beijing Peking Union Medical College Hospital","city":"Beijing","zip":"100730","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Beijing Pinggu District Hospital","city":"Beijing","zip":"101200","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Beijing Tsinghua Changgung Hospital","city":"Beijing","zip":"102202","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Pingxiang People's Hospital","city":"Pingxiang","zip":"337000","country":"China","geoPoint":{"lat":27.61672,"lon":113.85353}},{"facility":"Shanghai Putuo District Center Hospital","city":"Shanghai","zip":"200062","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Tianjin People's Hospital","city":"Tianjin","zip":"300121","country":"China","geoPoint":{"lat":39.14222,"lon":117.17667}},{"facility":"The Fourth People's Hospital of Zigong City","city":"Zigong","country":"China","geoPoint":{"lat":29.34162,"lon":104.77689}},{"facility":"King Edward Memorial Hospital and Research Center","city":"Mumbai","state":"Maharashtra","zip":"400012","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"facility":"BSES Municipal General Hsptl","city":"Mumbai","state":"Maharashtra","zip":"400058","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"facility":"Apollo Gleneagles Hospitals Kolkata","city":"Kolkata","state":"West Bengal","zip":"700054","country":"India","geoPoint":{"lat":22.56263,"lon":88.36304}},{"facility":"Fortis Hospital","city":"Delhi","zip":"110088","country":"India","geoPoint":{"lat":28.65195,"lon":77.23149}},{"facility":"Kyung Hee University Hospital","city":"Seoul","state":"Gangdong-gu","zip":"02447","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam","state":"Geonggi-do","zip":"13620","country":"South Korea","geoPoint":{"lat":35.48474,"lon":129.30505}},{"facility":"Bucheon St. Mary's Hospital","city":"Bucheon-si","state":"Gyeonggi-do","zip":"14647","country":"South Korea","geoPoint":{"lat":37.49889,"lon":126.78306}},{"facility":"Hanyang University Guri Hospital","city":"Guri-si","state":"Gyeonggido","zip":"11923","country":"South Korea","geoPoint":{"lat":37.5986,"lon":127.1394}},{"facility":"Yonsei University Wonju Severance Christian Hospital","city":"Gangwon-do","state":"Korea","zip":"220-701","country":"South Korea"},{"facility":"Ulsan University Hospital","city":"Ulsan","state":"Korea","zip":"44033","country":"South Korea","geoPoint":{"lat":35.53722,"lon":129.31667}},{"facility":"Inje University Sanggye Paik Hospital","city":"Seoul","state":"Seoul-teukbyeolsi","zip":"01757","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Korea University Anam Hospital","city":"Seoul","state":"Seoul-teukbyeolsi","zip":"02841","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Keimyung University Dongsan Hospital","city":"Daegu","state":"Taegu-Kwangyǒkshi","zip":"41931","country":"South Korea","geoPoint":{"lat":35.87028,"lon":128.59111}},{"facility":"Korea University Ansan Hospital","city":"Ansan-si","zip":"15355","country":"South Korea","geoPoint":{"lat":37.32361,"lon":126.82194}},{"facility":"Severance Hospital","city":"Seoul","zip":"03722","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Asan Medical Center","city":"Seoul","zip":"05505","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Hallym University Kangnam Sacred Heart Hospital","city":"Seoul","zip":"07441","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}}]},"referencesModule":{"references":[{"pmid":"38494574","type":"DERIVED","citation":"Bi Y, Lu S, Tang J, Du L, Ji L. Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups. Diabetes Ther. 2024 May;15(5):1125-1137. doi: 10.1007/s13300-024-01561-2. Epub 2024 Mar 18."},{"pmid":"37231074","type":"DERIVED","citation":"Gao L, Lee BW, Chawla M, Kim J, Huo L, Du L, Huang Y, Ji L. Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial. Nat Med. 2023 Jun;29(6):1500-1510. doi: 10.1038/s41591-023-02344-1. Epub 2023 May 25."}]},"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. 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":"http://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"5 mg Tirzepatide","description":"Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week (QW)."},{"id":"FG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"FG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"FG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"230"},{"groupId":"FG001","numSubjects":"228"},{"groupId":"FG002","numSubjects":"229"},{"groupId":"FG003","numSubjects":"230"}]},{"type":"Received At Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"230"},{"groupId":"FG001","numSubjects":"228"},{"groupId":"FG002","numSubjects":"229"},{"groupId":"FG003","numSubjects":"220"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"213"},{"groupId":"FG001","numSubjects":"201"},{"groupId":"FG002","numSubjects":"200"},{"groupId":"FG003","numSubjects":"201"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"29"},{"groupId":"FG003","numSubjects":"29"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"18"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"20"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Participant Could Not Continue Due to Work Related Reasons","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Covid 19","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Participant Thought there were Too Many Adverse Events","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Participant was Reluctant to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Participant Did Not Come for the Visit","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"BG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"BG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"BG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"230"},{"groupId":"BG001","value":"228"},{"groupId":"BG002","value":"229"},{"groupId":"BG003","value":"220"},{"groupId":"BG004","value":"907"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.10","spread":"11.25"},{"groupId":"BG001","value":"53.50","spread":"11.14"},{"groupId":"BG002","value":"54.30","spread":"11.65"},{"groupId":"BG003","value":"55.60","spread":"11.40"},{"groupId":"BG004","value":"54.10","spread":"11.38"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"96"},{"groupId":"BG001","value":"102"},{"groupId":"BG002","value":"100"},{"groupId":"BG003","value":"102"},{"groupId":"BG004","value":"400"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"134"},{"groupId":"BG001","value":"126"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"118"},{"groupId":"BG004","value":"507"}]}]}]},{"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":"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":"230"},{"groupId":"BG001","value":"228"},{"groupId":"BG002","value":"229"},{"groupId":"BG003","value":"220"},{"groupId":"BG004","value":"907"}]}]}]},{"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":"225"},{"groupId":"BG001","value":"225"},{"groupId":"BG002","value":"226"},{"groupId":"BG003","value":"216"},{"groupId":"BG004","value":"892"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"5"}]},{"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":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"10"}]},{"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":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Australia","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"15"}]}]},{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"190"},{"groupId":"BG001","value":"192"},{"groupId":"BG002","value":"190"},{"groupId":"BG003","value":"184"},{"groupId":"BG004","value":"756"}]}]},{"title":"India","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"32"}]}]},{"title":"South Korea","categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"25"},{"groupId":"BG004","value":"104"}]}]}]},{"title":"Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.77","spread":"0.976"},{"groupId":"BG001","value":"8.70","spread":"0.955"},{"groupId":"BG002","value":"8.67","spread":"0.960"},{"groupId":"BG003","value":"8.68","spread":"0.934"},{"groupId":"BG004","value":"8.71","spread":"0.956"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean 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 covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants belonging to the 10 mg, 15 mg Tirzepatide and Insulin Glargine arms who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG002","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"193"},{"groupId":"OG002","value":"193"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.44","spread":"0.073"},{"groupId":"OG001","value":"-2.49","spread":"0.072"},{"groupId":"OG002","value":"-0.95","spread":"0.073"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"The study was powered for superiority in HbA1c. The sample size provided \\>99% power to show noninferiority assuming a 0.4% noninferiority (NI) boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common standard deviation (SD) of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.","paramType":"LS Mean Difference","paramValue":"-1.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.69","ciUpperLimit":"-1.29"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"The study was powered for superiority in HbA1c. The sample size provided \\>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.","paramType":"LS Mean Difference","paramValue":"-1.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.74","ciUpperLimit":"-1.34"}]},{"type":"SECONDARY","title":"Mean 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 with covariates Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants belonging to the 5 mg Tirzepatide and Insulin Glargine arms who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","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":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"193"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.24","spread":"0.070"},{"groupId":"OG001","value":"-0.95","spread":"0.073"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"The study was powered for superiority in HbA1c. The sample size provided \\>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.","paramType":"LS Mean Difference","paramValue":"-1.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.49","ciUpperLimit":"-1.09"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Body Weight","description":"LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\\<= 8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","populationDescription":"All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","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 tirzepatide administered SC QW."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"194"},{"groupId":"OG002","value":"193"},{"groupId":"OG003","value":"194"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.0","spread":"0.32"},{"groupId":"OG001","value":"-7.0","spread":"0.33"},{"groupId":"OG002","value":"-7.2","spread":"0.33"},{"groupId":"OG003","value":"1.5","spread":"0.33"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-6.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.4","ciUpperLimit":"-5.6"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-8.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.5","ciUpperLimit":"-7.6"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-8.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.6","ciUpperLimit":"-7.7"}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving an HbA1c Target Value of <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. Imputed data includes observed value and imputed value if endpoint measure is missing.","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"222"},{"groupId":"OG002","value":"224"},{"groupId":"OG003","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"75.44"},{"groupId":"OG001","value":"86.04"},{"groupId":"OG002","value":"84.38"},{"groupId":"OG003","value":"23.72"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"14.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.94","ciUpperLimit":"23.64"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"28.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"16.72","ciUpperLimit":"49.49"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"25.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"14.88","ciUpperLimit":"42.95"}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving an HbA1c Target Value of <5.7%","description":"HbA1c is the glycosylated fraction of hemoglobin A. Imputed data includes observed value and imputed value if endpoint measure is missing.","populationDescription":"All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"222"},{"groupId":"OG002","value":"224"},{"groupId":"OG003","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.91"},{"groupId":"OG001","value":"20.72"},{"groupId":"OG002","value":"27.68"},{"groupId":"OG003","value":"0.00"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.002","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"82.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.13","ciUpperLimit":"1327.81"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"124.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.79","ciUpperLimit":"1997.01"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"184.90","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"11.59","ciUpperLimit":"2950.73"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Fasting Serum Glucose","description":"Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\\<= 8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","populationDescription":"All randomized participants who had received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams per deciliter (mg/dL)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"193"},{"groupId":"OG002","value":"192"},{"groupId":"OG003","value":"194"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-58.6","spread":"2.13"},{"groupId":"OG001","value":"-66.2","spread":"2.19"},{"groupId":"OG002","value":"-64.8","spread":"2.19"},{"groupId":"OG003","value":"-46.2","spread":"2.19"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-12.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-18.3","ciUpperLimit":"-6.3"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-20.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-26.1","ciUpperLimit":"-13.9"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-18.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-24.6","ciUpperLimit":"-12.5"}]},{"type":"SECONDARY","title":"Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values","description":"The SMBG data was 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. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\\<= 8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","populationDescription":"All randomized participants who have received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams per deciliter (mg/dL)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"193"},{"groupId":"OG002","value":"186"},{"groupId":"OG003","value":"188"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-77.0","spread":"2.09"},{"groupId":"OG001","value":"-83.4","spread":"2.16"},{"groupId":"OG002","value":"-84.6","spread":"2.18"},{"groupId":"OG003","value":"-42.8","spread":"2.18"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-34.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-40.1","ciUpperLimit":"-28.3"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-40.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.7","ciUpperLimit":"-34.6"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-41.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-47.9","ciUpperLimit":"-35.8"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Imputed data includes observed value and imputed value if endpoint measure is missing.","populationDescription":"All randomized participants who received at least one dose of study drug, had a baseline and had at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"222"},{"groupId":"OG002","value":"224"},{"groupId":"OG003","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"55.70"},{"groupId":"OG001","value":"71.62"},{"groupId":"OG002","value":"74.11"},{"groupId":"OG003","value":"5.58"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"21.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"11.63","ciUpperLimit":"41.20"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"43.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"22.96","ciUpperLimit":"83.50"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"48.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"25.34","ciUpperLimit":"92.49"}]},{"type":"SECONDARY","title":"Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction 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 treatment satisfaction score 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 model for endpoint measures with Baseline + Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline OAM Use (Met, Met plus SU) + Treatment (Type III sum of squares) as covariates.","populationDescription":"All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","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":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"200"},{"groupId":"OG002","value":"195"},{"groupId":"OG003","value":"196"}]}],"classes":[{"title":"Hyperglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"0.12"},{"groupId":"OG001","value":"-2.1","spread":"0.12"},{"groupId":"OG002","value":"-2.0","spread":"0.12"},{"groupId":"OG003","value":"-1.3","spread":"0.12"}]}]},{"title":"Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"-1.9","spread":"0.11"},{"groupId":"OG001","value":"-1.9","spread":"0.12"},{"groupId":"OG002","value":"-2.0","spread":"0.12"},{"groupId":"OG003","value":"-1.8","spread":"0.12"}]}]},{"title":"Treatment Satisfaction Score","categories":[{"measurements":[{"groupId":"OG000","value":"16.0","spread":"0.27"},{"groupId":"OG001","value":"15.8","spread":"0.28"},{"groupId":"OG002","value":"15.9","spread":"0.29"},{"groupId":"OG003","value":"14.2","spread":"0.28"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.007","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.81","ciUpperLimit":"-0.13"},{"groupIds":["OG001","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.11","ciUpperLimit":"-0.43"},{"groupIds":["OG002","OG003"],"groupDescription":"Hyperglycemia","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.71","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.05","ciUpperLimit":"-0.36"},{"groupIds":["OG000","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.384","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.46","ciUpperLimit":"0.18"},{"groupIds":["OG001","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.307","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.49","ciUpperLimit":"0.16"},{"groupIds":["OG002","OG003"],"groupDescription":"Hypoglycemia","nonInferiorityType":"SUPERIORITY","pValue":"0.184","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.55","ciUpperLimit":"0.11"},{"groupIds":["OG000","OG003"],"groupDescription":"Treatment Satisfaction Score","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"1.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.03","ciUpperLimit":"2.59"},{"groupIds":["OG001","OG003"],"groupDescription":"Treatment Satisfaction Score","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"1.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.84","ciUpperLimit":"2.41"},{"groupIds":["OG002","OG003"],"groupDescription":"Treatment Satisfaction Score","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"1.68","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.89","ciUpperLimit":"2.47"}]},{"type":"SECONDARY","title":"Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia","description":"The hypoglycemia events were defined by participant reported events with blood glucose \\< 54 mg/dL \\[\\<3.0 Millimole per Liter (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 post-baseline hypoglycemia was estimated by negative binomial model: Number of episodes = Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\\<= 8.5%, \\>8.5%) + 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, had a baseline and at least one post-baseline value, excluding data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date + 7 days).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Episodes/participant/365.25 days","timeFrame":"Baseline through end of safety follow-up (Up To Week 44)","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW."},{"id":"OG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"228"},{"groupId":"OG002","value":"229"},{"groupId":"OG003","value":"220"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0658","spread":"0.02603"},{"groupId":"OG001","value":"0.0890","spread":"0.03196"},{"groupId":"OG002","value":"0.0700","spread":"0.02273"},{"groupId":"OG003","value":"0.0538","spread":"0.01594"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline Through End of Safety Follow-Up (Up To Week 44).","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":"Participants received 5 mg tirzepatide administered SC QW.","deathsNumAffected":0,"deathsNumAtRisk":230,"seriousNumAffected":15,"seriousNumAtRisk":230,"otherNumAffected":174,"otherNumAtRisk":230},{"id":"EG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW.","deathsNumAffected":0,"deathsNumAtRisk":228,"seriousNumAffected":14,"seriousNumAtRisk":228,"otherNumAffected":201,"otherNumAtRisk":228},{"id":"EG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW.","deathsNumAffected":1,"deathsNumAtRisk":229,"seriousNumAffected":15,"seriousNumAtRisk":229,"otherNumAffected":193,"otherNumAtRisk":229},{"id":"EG003","title":"Insulin Glargine","description":"Participants received insulin glargine administered QD SC. The starting dose of insulin glargine was 6 IU/day at bedtime, titrated to a FBG between 72-100 mg/dL, following a TTT algorithm.","deathsNumAffected":2,"deathsNumAtRisk":220,"seriousNumAffected":20,"seriousNumAtRisk":220,"otherNumAffected":83,"otherNumAtRisk":220}],"seriousEvents":[{"term":"Lymphoid tissue hyperplasia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Cardiac failure acute","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":220}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Macular oedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Anal fissure","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Colitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Inguinal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Mechanical ileus","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Pancreatitis acute","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Umbilical hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Sudden cardiac death","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Sudden death","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Epididymitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":134},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":126},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":129},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":118}]},{"term":"Febrile infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Herpes zoster","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Femur fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Meniscus injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Muscle rupture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Wrist fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Cardiac function test","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Spondylolisthesis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Adenocarcinoma of colon","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Benign breast neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Lipoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Meningioma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Ovarian germ cell teratoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":96},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":102},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":100},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":102}]},{"term":"Papillary thyroid cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Cerebellar haemorrhage","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Cerebral infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Cerebral ischaemia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Lacunar infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Vertebrobasilar insufficiency","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Ectopic pregnancy","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":96},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":102},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":102}]},{"term":"Calculus urinary","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Adenomyosis","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":96},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":102},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":100},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":102}]},{"term":"Perineal pain","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Nasal polyps","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Vocal cord polyp","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":230},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":228},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]}],"otherEvents":[{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":54,"numAffected":19,"numAtRisk":230},{"groupId":"EG001","numEvents":63,"numAffected":25,"numAtRisk":228},{"groupId":"EG002","numEvents":73,"numAffected":34,"numAtRisk":229},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":220}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":12,"numAtRisk":230},{"groupId":"EG001","numEvents":23,"numAffected":17,"numAtRisk":228},{"groupId":"EG002","numEvents":33,"numAffected":23,"numAtRisk":229},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":220}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":181,"numAffected":77,"numAtRisk":230},{"groupId":"EG001","numEvents":277,"numAffected":103,"numAtRisk":228},{"groupId":"EG002","numEvents":301,"numAffected":101,"numAtRisk":229},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":220}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":32,"numAffected":6,"numAtRisk":230},{"groupId":"EG001","numEvents":15,"numAffected":11,"numAtRisk":228},{"groupId":"EG002","numEvents":38,"numAffected":12,"numAtRisk":229},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":220}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":19,"numAffected":10,"numAtRisk":230},{"groupId":"EG001","numEvents":47,"numAffected":14,"numAtRisk":228},{"groupId":"EG002","numEvents":35,"numAffected":9,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":40,"numAffected":20,"numAtRisk":230},{"groupId":"EG001","numEvents":70,"numAffected":23,"numAtRisk":228},{"groupId":"EG002","numEvents":52,"numAffected":18,"numAtRisk":229},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":220}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":100,"numAffected":46,"numAtRisk":230},{"groupId":"EG001","numEvents":230,"numAffected":75,"numAtRisk":228},{"groupId":"EG002","numEvents":231,"numAffected":73,"numAtRisk":229},{"groupId":"EG003","numEvents":6,"numAffected":5,"numAtRisk":220}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":32,"numAffected":21,"numAtRisk":230},{"groupId":"EG001","numEvents":105,"numAffected":34,"numAtRisk":228},{"groupId":"EG002","numEvents":79,"numAffected":29,"numAtRisk":229},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":220}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":7,"numAtRisk":230},{"groupId":"EG001","numEvents":17,"numAffected":14,"numAtRisk":228},{"groupId":"EG002","numEvents":13,"numAffected":10,"numAtRisk":229},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":220}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":12,"numAtRisk":230},{"groupId":"EG001","numEvents":44,"numAffected":23,"numAtRisk":228},{"groupId":"EG002","numEvents":36,"numAffected":17,"numAtRisk":229},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":220}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":17,"numAffected":16,"numAtRisk":230},{"groupId":"EG001","numEvents":18,"numAffected":14,"numAtRisk":228},{"groupId":"EG002","numEvents":19,"numAffected":14,"numAtRisk":229},{"groupId":"EG003","numEvents":21,"numAffected":17,"numAtRisk":220}]},{"term":"Amylase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":15,"numAffected":12,"numAtRisk":230},{"groupId":"EG001","numEvents":19,"numAffected":16,"numAtRisk":228},{"groupId":"EG002","numEvents":17,"numAffected":15,"numAtRisk":229},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":220}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":36,"numAffected":32,"numAtRisk":230},{"groupId":"EG001","numEvents":34,"numAffected":32,"numAtRisk":228},{"groupId":"EG002","numEvents":35,"numAffected":30,"numAtRisk":229},{"groupId":"EG003","numEvents":6,"numAffected":6,"numAtRisk":220}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":179,"numAffected":74,"numAtRisk":230},{"groupId":"EG001","numEvents":331,"numAffected":109,"numAtRisk":228},{"groupId":"EG002","numEvents":259,"numAffected":102,"numAtRisk":229},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":220}]},{"term":"Hyperglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":5,"numAtRisk":230},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":228},{"groupId":"EG002","numEvents":4,"numAffected":2,"numAtRisk":229},{"groupId":"EG003","numEvents":27,"numAffected":18,"numAtRisk":220}]},{"term":"Hyperlipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":230},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":228},{"groupId":"EG002","numEvents":9,"numAffected":9,"numAtRisk":229},{"groupId":"EG003","numEvents":11,"numAffected":11,"numAtRisk":220}]},{"term":"Hyperuricaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":28,"numAffected":27,"numAtRisk":230},{"groupId":"EG001","numEvents":35,"numAffected":28,"numAtRisk":228},{"groupId":"EG002","numEvents":28,"numAffected":27,"numAtRisk":229},{"groupId":"EG003","numEvents":27,"numAffected":24,"numAtRisk":220}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":16,"numAffected":10,"numAtRisk":230},{"groupId":"EG001","numEvents":21,"numAffected":13,"numAtRisk":228},{"groupId":"EG002","numEvents":37,"numAffected":24,"numAtRisk":229},{"groupId":"EG003","numEvents":11,"numAffected":10,"numAtRisk":220}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"LTE60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2021-02-23","uploadDate":"2022-09-23T06:20","filename":"Prot_000.pdf","size":5940607},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2021-12-15","uploadDate":"2022-09-23T06:20","filename":"SAP_001.pdf","size":4119423}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2022-11-18","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000098860","term":"Tirzepatide"},{"id":"D000069036","term":"Insulin Glargine"}],"ancestors":[{"id":"D000067757","term":"Glucagon-Like Peptide-1 Receptor"},{"id":"D000067756","term":"Glucagon-Like Peptide Receptors"},{"id":"D043562","term":"Receptors, G-Protein-Coupled"},{"id":"D011956","term":"Receptors, Cell Surface"},{"id":"D008565","term":"Membrane Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D011964","term":"Receptors, Gastrointestinal Hormone"},{"id":"D018000","term":"Receptors, Peptide"},{"id":"D049528","term":"Insulin, Long-Acting"},{"id":"D061385","term":"Insulins"},{"id":"D010187","term":"Pancreatic Hormones"},{"id":"D036361","term":"Peptide Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"},{"id":"D010455","term":"Peptides"}]}},"hasResults":true}