| Outcome Measures: |
Primary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, An SAE is any AE from this study that results in one of the following outcomes: * Death * Initial or prolonged inpatient hospitalization * A life-threatening experience (that is, immediate risk of dying) * Persistent or significant disability/incapacity * Congenital anomaly/birth defect. * Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section., Baseline through Week 52 | Secondary: 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 + oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Percentage of Participants Who Achieve HbA1c <7%, Hemoglobin A1c (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 + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Mean Change From Baseline in Daily 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 endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (Type III sum of squares)., Baseline, Week 52|Change From Baseline in Body Weight, LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline, Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline, Week 52|Change From Baseline in Fasting Insulin, LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Change From Baseline in Fasting C-Peptide, LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin), The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Change From Baseline in HOMA-2S (Insulin), The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy, 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., Baseline through Week 56|Number of Participants With Anti-Tirzepatide Antibodies, Number of Participants with Anti-Tirzepatide Antibodies, Baseline through Week 52
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| Locations: |
Akaicho Clinic, Chiba-shi, Chiba, 260 0804, Japan|Kashiwa hospital, Kashiwa, Chiba, 277-0825, Japan|Yuri Ono Clinic, Sapporo, Hokkaido, 060-0001, Japan|Manda Hospital, Sapporo, Hokkaido, 060-0062, Japan|Miyanomori Hospital, Sapporo, Hokkaido, 064-8570, Japan|Ikeda Hospital, Amagasaki, Hyogo, 661-0002, Japan|Nakamoto Naika Clinic, Mito, Ibaraki, 310 0826, Japan|Naka Memorial Clinic, Naka, Ibaraki, 311-0113, Japan|Ohishi Naika Clinic, Tsuchiura, Ibaraki, 300-0835, Japan|Takai Naika Clinic, Kamakura, Kanagawa, 247-0056, Japan|Tsuruma Kaneshiro Diabetes Clinic, Yamato, Kanagawa, 242-0004, Japan|Yokohama Minoru Clinic, Yokohama, Kanagawa, 232-0064, Japan|H.E.C. Science Clinic, Yokohama, Kanagawa, 235-0045, Japan|Takatsuki Red Cross Hospital, Takatsuki, Osaka, 569-1096, Japan|Otsu City Hospital, Otsu, Shiga, 520-0804, Japan|Wakakusa Clinic, Shimotsuke, Tochigi, 329-0433, Japan|Seiwa Clinic, Adachi-ku, Tokyo, 123 0845, 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|Tokyo Center Clinic, Chuo-ku, Tokyo, 103-0028, Japan|Tokyo Clinical Trial Centre Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan|Kanno Naika, Mitaka, Tokyo, 181 0013, Japan|Shinjuku Research Park Clinic, Shinjuku-Ku, Tokyo, 169-0073, Japan|Futata Tetsuhiro Clinic, Fukuoka, 819 0006, Japan|Morinaga Ueno Clinic, Kumamoto, 860 0863, Japan|Jinnouchi Hospital, Kumamoto, 862-0976, Japan|Abe Diabetes Clinic, Oita, 870-0039, Japan|Saiseikai Noe Hospital, Osaka, 536 0001, Japan|Kitada Clinic, Osaka, 538 0044, Japan|Kansai Denryoku Hospital, Osaka, 553-0003, Japan|Shizuoka City Shizuoka Hospital, Shizuoka, 420-8630, Japan|Suruga Clinic, Shizuoka, 424-0855, Japan
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