| 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 with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40 | Secondary: Change From Baseline in Body Weight, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|Percentage of Participants With HbA1c Target Value of <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 40|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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|Percentage of Participants With HbA1c Target Value of <5.7%, 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 40|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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|Percentage of Participants Who Achieved Weight Loss ≥5%, Percentage of Participants who Achieved Weight Loss ≥5%., Week 40|Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] 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: number of episodes = Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable., Baseline through end of safety follow-up (up to week 44)|Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide, Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported., Week 7, 15 and 23
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| Locations: |
National Research Institute, Huntington Park, California, 90255, United States|National Research Institute, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|National Research Institute, Panorama City, California, 91402, United States|Southern California Dermatology, Santa Ana, California, 92701, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|Encore Medical Research, LLC, Hollywood, Florida, 33021, United States|Axcess Medical Research, Loxahatchee Groves, Florida, 33470, United States|South Florida Wellness & Clinical Research Institute, Margate, Florida, 33063, United States|Suncoast Research Group, LLC, Miami, Florida, 33135, United States|Agile Clinical Research Trials, Atlanta, Georgia, 30328, United States|Sky Clinical Research Network, Atlanta, Georgia, 30331, United States|Cotton O'Neil Clinic, Topeka, Kansas, 66606, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|StudyMetrix Research, LLC, Saint Peters, Missouri, 63303, United States|Aventiv Research, Columbus, Ohio, 43213, United States|Intend Research, Norman, Oklahoma, 73069, United States|The Corvallis Clinic P.C., Corvallis, Oregon, 97330, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Family Medical Associates, Levittown, Pennsylvania, 19056, United States|Preferred Primary Care Physicians, Pittsburgh, Pennsylvania, 15236, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|Capital Clinical Research Center, Olympia, Washington, 98502, United States|Rockwood Clinic Research Center, Spokane, Washington, 99220, United States|Dr. Jivraj Mehta Smarak Health Foundation, Ahmedabad, Gujarat, 380007, India|Bangalore Medical College and Research Institute, Bangalore, Karnataka, 560 002, India|M S Ramaiah Medical College Hospital, Bangalore, Karnataka, 560054, India|BSES Municipal General Hsptl, Mumbai, Maharashtra, 400058, India|Ruby Hall Clinic and Grant Medical Foundation, Pune, Maharashtra, 411001, India|Vijay Vallabh Hospital, Virar, Maharashtra, 401303, India|Lifepoint Multispecialty Hsptl, Wakad, Pune, 411057, India|Ramdevrao Hospital, Hyderabad, Telangana, 500072, India|Gandhi Hospital, Telangana, 500003, India|Minamiakatsuka Clinic, Mito, Ibaraki, 311-4153, 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|Takatsuki Red Cross Hospital, Takatsuki, Osaka, 569-1096, Japan|Meiwa Hospital, Chiyodaku, Tokyo, 101 0041, Japan|Tokyo-Eki Center-building Clinic, Chuo-ku, Tokyo, 103-0027, Japan|Tokyo Center Clinic, Chuo-ku, Tokyo, 103-0028, Japan|IHL Shinagawa East One Medical Clinic, Minato-ku, Tokyo, 108 0075, Japan|Sato Naika Clinic, Ota-ku, Tokyo, 143-0015, Japan|Hospital Universitario UANL, Monterrey, Nuevo León, 64460, Mexico|Unidad Medica para la Salud Integral (UMSI), Monterrey, Nuevo León, 66465, Mexico|Centro de Estudios de Investigacion Metabolicos y Cardiovasc, Madero, Tamaulipas, 89440, Mexico|Investigacion en Salud y Metabolismo S.C, Chihuahua, 31217, Mexico|Clinical Research Puerto Rico, Inc., San Juan, 00909, Puerto Rico|GCM Medical Group PSC, San Juan, 00917, Puerto Rico
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