{"protocolSection":{"identificationModule":{"nctId":"NCT03861052","orgStudyIdInfo":{"id":"17077"},"secondaryIdInfos":[{"id":"I8F-JE-GPGO","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes","officialTitle":"A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus","acronym":"SURPASS J-mono"},"statusModule":{"statusVerifiedDate":"2022-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-05-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-03-10","type":"ACTUAL"},"completionDateStruct":{"date":"2021-03-31","type":"ACTUAL"},"studyFirstSubmitDate":"2019-03-01","studyFirstSubmitQcDate":"2019-03-01","studyFirstPostDateStruct":{"date":"2019-03-04","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-03-04","resultsFirstSubmitQcDate":"2022-04-13","resultsFirstPostDateStruct":{"date":"2022-04-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-04-13","lastUpdatePostDateStruct":{"date":"2022-04-14","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 reason for this study is to see if the study drug tirzepatide (LY3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in Japan."},"conditionsModule":{"conditions":["Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":636,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 5 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 52 weeks.","interventionNames":["Drug: Tirzepatide"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.","interventionNames":["Drug: Tirzepatide"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.","interventionNames":["Drug: Tirzepatide"]},{"label":"0.75 mg Dulaglutide","type":"ACTIVE_COMPARATOR","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.","interventionNames":["Drug: Dulaglutide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["0.75 mg Dulaglutide"],"otherNames":["LY2189265"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With HbA1c 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.","timeFrame":"Week 52"},{"measure":"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 for post-baseline measures: Variable = Baseline + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by analysis of covariance (ANCOVA) model for with Baseline + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Body Weight","description":"Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline","description":"Percentage of participants who achieve weight loss ≥5% from baseline.","timeFrame":"Week 52"},{"measure":"Change From Baseline in Fasting Insulin","description":"Fasting Insulin is a test used to measure the amount of insulin in the body. LS mean was determined by MMRM model for post-baseline measures with log (Actual Measurement) = log (Baseline) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Fasting C-Peptide","description":"Fasting C-peptide is a test used to measure the amount of C-peptide in the body. A high level of C-peptide can mean that body is making too much insulin. LS mean was determined by MMRM model for post-baseline measures: log (Actual Measurement) = log (Baseline) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin)","description":"HOMA-2B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in HOMA-2S (Insluin)","description":"HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 52"},{"measure":"Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia","description":"The hypoglycemia events were defined by participant reported events with blood glucose \\<54mg/dL) (\\<3.0 mmol/L\\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model for post-baseline comparisons between treatment and control group: number of episodes = baseline hypoglycemia incidence + baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + washout of antidiabetic medication + baseline hemoglobin A1C (%) + treatment, with log (exposure in days/365.25) as an offset variable.","timeFrame":"Baseline through Week 52"},{"measure":"Number of Participants With Anti-Tirzepatide Antibodies","description":"Number of participants with anti-tirzepatide antibodies. A participant is treatment emergent (TE) anti-drug antibody (ADA) evaluable if there is at least one non-missing test result for tirzepatide ADA for each of the baseline period and the postbaseline period. All percentages are relative to the total number of TE ADA evaluable participants in each treatment group. A TE ADA evaluable participant is considered to be TE ADA+ if the participant has at least one postbaseline titer that is a 4-fold or greater increase in titer from baseline measurement.","timeFrame":"Baseline through Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nParticipant must:\n\n* Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.\n* Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline:\n\n  * for participants who are oral antihyperglycemic medication (OAM)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline.\n  * for participants who have been taking OAM monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline.\n* Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.\n* Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive 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\nExclusion Criteria:\n\nParticipant must not:\n\n* Have type 1 diabetes mellitus.\n* Have had chronic or acute pancreatitis any time prior to study entry.\n* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment.\n* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.\n* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \\>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range.\n* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.\n* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.\n* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 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":"Akaicho Clinic","city":"Chiba","state":"Chiba","zip":"260 0804","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Medical corporation THY Tokuyama Clinic","city":"Chiba Mihama-ku","state":"Chiba","zip":"261-0004","country":"Japan"},{"facility":"National Hospital Organization Kure Medical Center","city":"Kure","state":"Hiroshima","zip":"737-0023","country":"Japan","geoPoint":{"lat":34.23222,"lon":132.56658}},{"facility":"Hasegawa Medical Clinic","city":"Chitose","state":"Hokkaido","zip":"066-0032","country":"Japan","geoPoint":{"lat":42.81944,"lon":141.65222}},{"facility":"Yuri Ono Clinic","city":"Sapporo","state":"Hokkaido","zip":"060-0001","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Watanabe Naika Clinic","city":"Nishinomiya","state":"Hyōgo","zip":"662-0971","country":"Japan","geoPoint":{"lat":34.71562,"lon":135.33199}},{"facility":"Hayashi Clinic","city":"Nishinomiya","state":"Hyōgo","zip":"663-8113","country":"Japan","geoPoint":{"lat":34.71562,"lon":135.33199}},{"facility":"Naka Memorial Clinic","city":"Naka","state":"Ibaraki","zip":"311-0113","country":"Japan","geoPoint":{"lat":36.05,"lon":140.16667}},{"facility":"Hayashi Diabetes Internal Medicine Clinic","city":"Chigasaki-sh","state":"Kanagawa","zip":"253-0044","country":"Japan"},{"facility":"Matoba Diabetes Clinic","city":"Ebina","state":"Kanagawa","zip":"243-0432","country":"Japan","geoPoint":{"lat":35.38121,"lon":139.39651}},{"facility":"Takai Naika Clinic","city":"Kamakura","state":"Kanagawa","zip":"247-0056","country":"Japan","geoPoint":{"lat":35.31085,"lon":139.54698}},{"facility":"Kanto Rosai Hospital","city":"Kawasaki","state":"Kanagawa","zip":"211-8510","country":"Japan","geoPoint":{"lat":35.52056,"lon":139.71722}},{"facility":"H.E.C. Science Clinic","city":"Yokohama","state":"Kanagawa","zip":"235-0045","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}},{"facility":"Medical Corporation Heishinkai OCROM Clinic","city":"Suita-shi","state":"Osaka","zip":"565-0853","country":"Japan"},{"facility":"Takatsuki Red Cross Hospital","city":"Takatsuki","state":"Osaka","zip":"569-1096","country":"Japan","geoPoint":{"lat":34.84833,"lon":135.61678}},{"facility":"Senrichuo Ekimae Clinic","city":"Toyonaka","state":"Osaka","zip":"560-0082","country":"Japan","geoPoint":{"lat":34.78244,"lon":135.46932}},{"facility":"Asano Clinic","city":"Kawagoe","state":"Saitama","zip":"350 0581","country":"Japan","geoPoint":{"lat":35.90861,"lon":139.48528}},{"facility":"Kawaguchi General Hospital","city":"Kawaguchi","state":"Saitama","zip":"332-8558","country":"Japan","geoPoint":{"lat":35.80521,"lon":139.71072}},{"facility":"Wakakusa Clinic","city":"Shimotsuke","state":"Tochigi","zip":"329-0433","country":"Japan","geoPoint":{"lat":36.41323,"lon":139.86622}},{"facility":"Seiwa Clinic","city":"Adachi-ku","state":"Tokyo","zip":"123 0845","country":"Japan"},{"facility":"HDC Atlas Clinic","city":"Chiyoda City","state":"Tokyo","zip":"102-0082","country":"Japan","geoPoint":{"lat":35.68449,"lon":139.75056}},{"facility":"Meiwa Hospital","city":"Chiyodaku","state":"Tokyo","zip":"101 0041","country":"Japan"},{"facility":"Asahi Life Foundation Adult Disease Research Center","city":"Chuo-ku","state":"Tokyo","zip":"103 0002","country":"Japan"},{"facility":"Nihonbashi Sakura Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0025","country":"Japan"},{"facility":"Tokyo-Eki Center-building Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0027","country":"Japan"},{"facility":"Medical Corporation Chiseikai Tokyo Center Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0028","country":"Japan"},{"facility":"Tokyo aSBo Clinic","city":"Chuo-ku","state":"Tokyo","zip":"104 0031","country":"Japan"},{"facility":"Fukuwa Clinic","city":"Chuo-ku","state":"Tokyo","zip":"104-0031","country":"Japan"},{"facility":"IHL Shinagawa East One Medical Clinic","city":"Minato-ku","state":"Tokyo","zip":"108-0075","country":"Japan"},{"facility":"Sato Medical Clinic","city":"Ootaku","state":"Tokyo","zip":"143-0015","country":"Japan"},{"facility":"Shinjuku Research Park Clinic","city":"Shinjuku","state":"Tokyo","zip":"169-0073","country":"Japan","geoPoint":{"lat":35.69115,"lon":139.70854}},{"facility":"Medical Corporation Heishinkai ToCROM Clinic","city":"Shinjuku-ku","state":"Tokyo","zip":"160 0008","country":"Japan"},{"facility":"Tomonaga Clinic","city":"Shinjuku-ku","state":"Tokyo","zip":"160 0022","country":"Japan"},{"facility":"Shinei Clinic","city":"Suginami","state":"Tokyo","zip":"166-0003","country":"Japan"},{"facility":"Ikebukuro Metropolitan Clinic","city":"Toshima-ku","state":"Tokyo","zip":"171-0021","country":"Japan"},{"facility":"Futata Tetsuhiro Clinic","city":"Fukuoka","zip":"810-0006","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"JR Hiroshima Hospital","city":"Hiroshima","zip":"732-0057","country":"Japan","geoPoint":{"lat":34.4,"lon":132.45}},{"facility":"Yoshimura Clinic","city":"Kumamoto","zip":"861-8039","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Keiseikai Kajiyama Clinic","city":"Kyoto","zip":"6008898","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"OKAYAMA Medical Center","city":"Okayama","zip":"701-1192","country":"Japan","geoPoint":{"lat":34.65,"lon":133.93333}},{"facility":"AMC Nishiumeda Clinic","city":"Osaka","zip":"530-0001","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Kitada Clinic","city":"Osaka","zip":"538-0044","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Nanko Clinic","city":"Osaka","zip":"559-0011","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Abe Clinic","city":"Ōita","zip":"870-0039","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}},{"facility":"Suruga Clinic","city":"Shizuoka","zip":"424-0855","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}},{"facility":"Yokohama Minoru Clinic","city":"Yokohama","zip":"232-0064","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}}]},"referencesModule":{"references":[{"pmid":"40711720","type":"DERIVED","citation":"Mimura H, Oura T, Chin R, Hirase T, Shimono D. Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis. Diabetes Ther. 2025 Sep;16(9):1871-1885. doi: 10.1007/s13300-025-01775-y. Epub 2025 Jul 25."},{"pmid":"39951042","type":"DERIVED","citation":"Hamamoto Y, Oura T, Hirase T. Insulin Sensitivity and Beta-Cell Function Following Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J-mono Analysis. Diabetes Ther. 2025 Apr;16(4):717-729. doi: 10.1007/s13300-025-01704-z. Epub 2025 Feb 14."},{"pmid":"38310163","type":"DERIVED","citation":"Onishi Y, Oura T, Takeuchi M. Metabolic Abnormalities Following Tirzepatide Monotherapy in Japanese Patients with Type 2 Diabetes: A Phase 3 SURPASS J-mono Post Hoc Analysis. Diabetes Ther. 2024 Mar;15(3):649-661. doi: 10.1007/s13300-024-01534-5. Epub 2024 Feb 4."},{"pmid":"37843771","type":"DERIVED","citation":"Ishii H, Oura T, Takeuchi M. Treatment Satisfaction and Quality of Life with Tirzepatide Versus Dulaglutide Among Japanese Patients with Type 2 Diabetes: Exploratory Evaluation of the SURPASS J-mono Trial. Diabetes Ther. 2023 Dec;14(12):2173-2183. doi: 10.1007/s13300-023-01485-3. Epub 2023 Oct 16."},{"pmid":"35914543","type":"DERIVED","citation":"Inagaki N, Takeuchi M, Oura T, Imaoka T, Seino Y. Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Sep;10(9):623-633. doi: 10.1016/S2213-8587(22)00188-7. Epub 2022 Jul 30."},{"pmid":"35210595","type":"DERIVED","citation":"Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24."}]},"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://www.clinicalstudydatarequest.com"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"FG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"FG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"FG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"158"},{"groupId":"FG002","numSubjects":"160"},{"groupId":"FG003","numSubjects":"159"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"158"},{"groupId":"FG002","numSubjects":"160"},{"groupId":"FG003","numSubjects":"159"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"151"},{"groupId":"FG002","numSubjects":"155"},{"groupId":"FG003","numSubjects":"154"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Relocation to other city","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 once weekly for 52 weeks."},{"id":"BG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks"},{"id":"BG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"BG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks"},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"159"},{"groupId":"BG001","value":"158"},{"groupId":"BG002","value":"160"},{"groupId":"BG003","value":"159"},{"groupId":"BG004","value":"636"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"123"},{"groupId":"BG002","value":"124"},{"groupId":"BG003","value":"111"},{"groupId":"BG004","value":"478"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"36"},{"groupId":"BG003","value":"48"},{"groupId":"BG004","value":"158"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"42"},{"groupId":"BG004","value":"155"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"113"},{"groupId":"BG001","value":"119"},{"groupId":"BG002","value":"132"},{"groupId":"BG003","value":"117"},{"groupId":"BG004","value":"481"}]}]}]},{"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":"159"},{"groupId":"BG001","value":"158"},{"groupId":"BG002","value":"160"},{"groupId":"BG003","value":"159"},{"groupId":"BG004","value":"636"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"159"},{"groupId":"BG001","value":"158"},{"groupId":"BG002","value":"160"},{"groupId":"BG003","value":"159"},{"groupId":"BG004","value":"636"}]}]}]},{"title":"Hemoglobin A1c [HbA1c]","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.18","spread":"0.88"},{"groupId":"BG001","value":"8.19","spread":"0.86"},{"groupId":"BG002","value":"8.19","spread":"0.89"},{"groupId":"BG003","value":"8.15","spread":"0.86"},{"groupId":"BG004","value":"8.18","spread":"0.87"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"156"},{"groupId":"OG002","value":"159"},{"groupId":"OG003","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.37","spread":"0.066"},{"groupId":"OG001","value":"-2.55","spread":"0.067"},{"groupId":"OG002","value":"-2.82","spread":"0.066"},{"groupId":"OG003","value":"-1.29","spread":"0.065"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-1.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.27","ciUpperLimit":"-0.90"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-1.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.45","ciUpperLimit":"-1.08"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-1.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.71","ciUpperLimit":"-1.35"}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c 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.","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"156"},{"groupId":"OG002","value":"159"},{"groupId":"OG003","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93.67"},{"groupId":"OG001","value":"96.79"},{"groupId":"OG002","value":"99.37"},{"groupId":"OG003","value":"67.30"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"9.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.53","ciUpperLimit":"21.55"},{"groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"20.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.73","ciUpperLimit":"54.71"},{"groupIds":["OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"85.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"15.80","ciUpperLimit":"460.58"}]},{"type":"SECONDARY","title":"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 for post-baseline measures: Variable = Baseline + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams per decilitre (mg/dL)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"156"},{"groupId":"OG002","value":"159"},{"groupId":"OG003","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-57.9","spread":"1.73"},{"groupId":"OG001","value":"-64.6","spread":"1.76"},{"groupId":"OG002","value":"-67.6","spread":"1.75"},{"groupId":"OG003","value":"-31.9","spread":"1.73"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-25.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-30.7","ciUpperLimit":"-21.1"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-32.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-37.5","ciUpperLimit":"-27.8"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-35.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-40.6","ciUpperLimit":"30.9"}]},{"type":"SECONDARY","title":"Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by analysis of covariance (ANCOVA) model for with Baseline + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 week"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 week"},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 week"},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"133"},{"groupId":"OG002","value":"135"},{"groupId":"OG003","value":"137"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-59.5","spread":"1.46"},{"groupId":"OG001","value":"-64.2","spread":"1.50"},{"groupId":"OG002","value":"-68.6","spread":"1.50"},{"groupId":"OG003","value":"-42.2","spread":"1.48"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-17.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-21.4","ciUpperLimit":"-13.2"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-22.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-26.1","ciUpperLimit":"-17.9"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"-26.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-30.5","ciUpperLimit":"-22.2"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram (kg)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"156"},{"groupId":"OG002","value":"159"},{"groupId":"OG003","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.8","spread":"0.41"},{"groupId":"OG001","value":"-8.5","spread":"0.42"},{"groupId":"OG002","value":"-10.7","spread":"0.41"},{"groupId":"OG003","value":"-0.5","spread":"0.41"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-5.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.4","ciUpperLimit":"-4.1"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-7.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.1","ciUpperLimit":"-6.8"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-10.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.3","ciUpperLimit":"-9.0"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline","description":"Percentage of participants who achieve weight loss ≥5% from baseline.","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"156"},{"groupId":"OG002","value":"159"},{"groupId":"OG003","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60.76"},{"groupId":"OG001","value":"82.05"},{"groupId":"OG002","value":"89.31"},{"groupId":"OG003","value":"10.69"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"14.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.88","ciUpperLimit":"26.46"},{"groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"44.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"23.12","ciUpperLimit":"87.45"},{"groupIds":["OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"82.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"39.84","ciUpperLimit":"171.52"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Insulin","description":"Fasting Insulin is a test used to measure the amount of insulin in the body. LS mean was determined by MMRM model for post-baseline measures with log (Actual Measurement) = log (Baseline) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milliunits per litre (mU/L)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"157"},{"groupId":"OG003","value":"155"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.07","spread":"0.374"},{"groupId":"OG001","value":"-1.87","spread":"0.344"},{"groupId":"OG002","value":"-2.00","spread":"0.335"},{"groupId":"OG003","value":"1.40","spread":"0.482"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-2.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.67","ciUpperLimit":"-1.28","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.610"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-3.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.43","ciUpperLimit":"-2.11","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.592"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-3.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.55","ciUpperLimit":"-2.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.587"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting C-Peptide","description":"Fasting C-peptide is a test used to measure the amount of C-peptide in the body. A high level of C-peptide can mean that body is making too much insulin. LS mean was determined by MMRM model for post-baseline measures: log (Actual Measurement) = log (Baseline) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"micrograms per liter (ug/L)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"157"},{"groupId":"OG003","value":"155"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.25","spread":"0.045"},{"groupId":"OG001","value":"-0.39","spread":"0.042"},{"groupId":"OG002","value":"-0.37","spread":"0.042"},{"groupId":"OG003","value":"0.01","spread":"0.052"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"-0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.069"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.53","ciUpperLimit":"-0.27","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.067"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"-0.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.067"}]},{"type":"SECONDARY","title":"Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin)","description":"HOMA-2B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of insulin sensitivity","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"147"},{"groupId":"OG003","value":"153"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.5","spread":"2.15"},{"groupId":"OG001","value":"43.0","spread":"2.38"},{"groupId":"OG002","value":"46.3","spread":"2.44"},{"groupId":"OG003","value":"22.4","spread":"1.66"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"16.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"10.7","ciUpperLimit":"21.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.72"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"20.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"14.9","ciUpperLimit":"26.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.90"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"23.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"18.1","ciUpperLimit":"29.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.95"}]},{"type":"SECONDARY","title":"Change From Baseline in HOMA-2S (Insluin)","description":"HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of insulin sensitivity","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"147"},{"groupId":"OG003","value":"153"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.5","spread":"3.38"},{"groupId":"OG001","value":"21.6","spread":"3.83"},{"groupId":"OG002","value":"25.7","spread":"3.95"},{"groupId":"OG003","value":"-5.4","spread":"2.52"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"19.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"11.7","ciUpperLimit":"28.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.22"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"27.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"18.0","ciUpperLimit":"36.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.59"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"31.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"22.0","ciUpperLimit":"40.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.68"}]},{"type":"SECONDARY","title":"Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia","description":"The hypoglycemia events were defined by participant reported events with blood glucose \\<54mg/dL) (\\<3.0 mmol/L\\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model for post-baseline comparisons between treatment and control group: number of episodes = baseline hypoglycemia incidence + baseline BMI Group (\\<25 or \\>=25 kg/m\\^2) + washout of antidiabetic medication + baseline hemoglobin A1C (%) + 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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes/participant/365.25 days","timeFrame":"Baseline through Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"160"},{"groupId":"OG003","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0.012"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Anti-Tirzepatide Antibodies","description":"Number of participants with anti-tirzepatide antibodies. A participant is treatment emergent (TE) anti-drug antibody (ADA) evaluable if there is at least one non-missing test result for tirzepatide ADA for each of the baseline period and the postbaseline period. All percentages are relative to the total number of TE ADA evaluable participants in each treatment group. A TE ADA evaluable participant is considered to be TE ADA+ if the participant has at least one postbaseline titer that is a 4-fold or greater increase in titer from baseline measurement.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks."},{"id":"OG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"160"},{"groupId":"OG003","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"102"},{"groupId":"OG002","value":"123"},{"groupId":"OG003","value":"8"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline through Week 52","description":"All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.","eventGroups":[{"id":"EG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC once weekly for 52 weeks.","deathsNumAffected":0,"deathsNumAtRisk":159,"seriousNumAffected":8,"seriousNumAtRisk":159,"otherNumAffected":131,"otherNumAtRisk":159},{"id":"EG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.","deathsNumAffected":0,"deathsNumAtRisk":158,"seriousNumAffected":10,"seriousNumAtRisk":158,"otherNumAffected":121,"otherNumAtRisk":158},{"id":"EG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.","deathsNumAffected":0,"deathsNumAtRisk":160,"seriousNumAffected":7,"seriousNumAtRisk":160,"otherNumAffected":134,"otherNumAtRisk":160},{"id":"EG003","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.","deathsNumAffected":0,"deathsNumAtRisk":159,"seriousNumAffected":14,"seriousNumAtRisk":159,"otherNumAffected":120,"otherNumAtRisk":159}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":159},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":158},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":160},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":159}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":159},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":158},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":160},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":159}]},{"term":"Sars-cov-2 test positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":159},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":158},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":160},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":159}]},{"term":"Jaw cyst","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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