| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c), 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)., Baseline, Week 52 | Secondary: Percentage of Participants With HbA1c of <7.0%, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time., Week 52|Change From Baseline in Fasting Serum Glucose, 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)., Baseline, Week 52|Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values, 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., Baseline, Week 52|Change From Baseline in Body Weight, 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)., Baseline, Week 52|Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline, Percentage of participants who achieve weight loss ≥5% from baseline., Week 52|Change From Baseline in Fasting Insulin, 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., Baseline, Week 52|Change From Baseline in Fasting C-Peptide, 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)., Baseline, Week 52|Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin), 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)., Baseline, Week 52|Change From Baseline in HOMA-2S (Insluin), 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)., Baseline, Week 52|Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia, 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., Baseline through Week 52|Number of Participants With Anti-Tirzepatide Antibodies, 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., Baseline through Week 52
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| Locations: |
Medical corporation THY Tokuyama Clinic, Chiba Mihama-ku, Chiba, 261-0004, Japan|Akaicho Clinic, Chiba-shi, Chiba, 260 0804, Japan|National Hospital Organization Kure Medical Center, Kure, Hiroshima, 737-0023, Japan|Hasegawa Medical Clinic, Chitose, Hokkaido, 066-0032, Japan|Yuri Ono Clinic, Sapporo, Hokkaido, 060-0001, Japan|Watanabe Naika Clinic, Nishinomiya, Hyogo, 662-0971, Japan|Hayashi Clinic, Nishinomiya, Hyogo, 663-8113, Japan|Naka Memorial Clinic, Naka, Ibaraki, 311-0113, Japan|Hayashi Diabetes Internal Medicine Clinic, Chigasaki-sh, Kanagawa, 253-0044, Japan|Matoba Diabetes Clinic, Ebina, Kanagawa, 243-0432, Japan|Takai Naika Clinic, Kamakura, Kanagawa, 247-0056, Japan|Kanto Rosai Hospital, Kawasaki, Kanagawa, 211-8510, Japan|H.E.C. Science Clinic, Yokohama, Kanagawa, 235-0045, Japan|Medical Corporation Heishinkai OCROM Clinic, Suita-shi, Osaka, 565-0853, Japan|Takatsuki Red Cross Hospital, Takatsuki, Osaka, 569-1096, Japan|Senrichuo Ekimae Clinic, Toyonaka, Osaka, 560-0082, Japan|Asano Clinic, Kawagoe, Saitama, 350 0581, Japan|Kawaguchi General Hospital, Kawaguchi, Saitama, 332-8558, Japan|Wakakusa Clinic, Shimotsuke, Tochigi, 329-0433, Japan|Seiwa Clinic, Adachi-ku, Tokyo, 123 0845, Japan|Meiwa Hospital, Chiyodaku, Tokyo, 101 0041, Japan|HDC Atlas Clinic, Chiyoda, Tokyo, 102-0082, Japan|Asahi Life Foundation Adult Disease Research Center, Chuo-ku, Tokyo, 103 0002, Japan|Nihonbashi Sakura Clinic, Chuo-ku, Tokyo, 103-0025, Japan|Tokyo-Eki Center-building Clinic, Chuo-ku, Tokyo, 103-0027, Japan|Medical Corporation Chiseikai Tokyo Center Clinic, Chuo-ku, Tokyo, 103-0028, Japan|Tokyo aSBo Clinic, Chuo-ku, Tokyo, 104 0031, Japan|Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan|IHL Shinagawa East One Medical Clinic, Minato-ku, Tokyo, 108-0075, Japan|Sato Medical Clinic, Ootaku, Tokyo, 143-0015, Japan|Medical Corporation Heishinkai ToCROM Clinic, Shinjuku-ku, Tokyo, 160 0008, Japan|Tomonaga Clinic, Shinjuku-ku, Tokyo, 160 0022, Japan|Shinjuku Research Park Clinic, Shinjuku, Tokyo, 169-0073, Japan|Shinei Clinic, Suginami, Tokyo, 166-0003, Japan|Ikebukuro Metropolitan Clinic, Toshima-ku, Tokyo, 171-0021, Japan|Futata Tetsuhiro Clinic, Fukuoka, 810-0006, Japan|JR Hiroshima Hospital, Hiroshima, 732-0057, Japan|Yoshimura Clinic, Kumamoto, 861-8039, Japan|Keiseikai Kajiyama Clinic, Kyoto, 6008898, Japan|Abe Clinic, Oita, 870-0039, Japan|OKAYAMA Medical Center, Okayama, 701-1192, Japan|AMC Nishiumeda Clinic, Osaka, 530-0001, Japan|Kitada Clinic, Osaka, 538-0044, Japan|Nanko Clinic, Osaka, 559-0011, Japan|Suruga Clinic, Shizuoka, 424-0855, Japan|Yokohama Minoru Clinic, Yokohama, 232-0064, Japan
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