| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg), 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 + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40 | Secondary: Change From Baseline in HbA1c (5 mg), 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 + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|Change From Baseline in Body Weight, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|Percentage of Participants Achieving an 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. LS Mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, 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 + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment (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|Percentage Change From Baseline in Daily Mean Insulin Glargine Dose, LS mean was calculated using MMRM model with log (Baseline) + Baseline Metformin Use (Yes, No) + Pooled Country + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, 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 Metformin Use (Yes, No) + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Treatment, with log (exposure in days/365.25) as an offset variable., Baseline through Safety Follow-Up (Up to Week 44)|Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide, AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported., Week 7, 15, 23 and 39 post dose|Percentage of Participants Achieving an 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
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| Locations: |
Valley Endocrine, Fresno, Fresno, California, 93720, United States|Sun Coast Clinical Research, Inc, New Port Richey, Florida, 34652, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03063, United States|Manhattan Medical Research, New York, New York, 10016, United States|Intend Research, Norman, Oklahoma, 73069, United States|Milan Kvapil s.r.o., Pribram, Středočeský Kraj, 26201, Czechia|Diacentrum Brandys n.L. s.r.o., Brandys Nad Labem-Stara Bolesl, 25001, Czechia|Diabetologicka ordinace pro dospele, Krnov, 79401, Czechia|Diahelp s.r.o., Interni a diabetologicka ambulance, Pardubice, 53002, Czechia|Lekarna Dr. Max, Praha 1, 11000, Czechia|Milan Kvapil s.r.o., Praha 4, 149 00, Czechia|RESTRIAL s.r.o., Praha 8, 181 00, Czechia|Praxis Dr. Jörg Lüdemann, Falkensee, Brandenburg, 14612, Germany|Arztpraxis Dr. Cornelia Marck, Pohlheim, Hessen, 35415, Germany|InnoDiab Forschung GmbH, Essen, Nordrhein-Westfalen, 45136, Germany|Institut für Diabetesforschung Münster GmbH, Münster, Nordrhein-Westfalen, 48145, Germany|Praxis Dr. Kempe - Dr. Stemler, Ludwigshafen am Rhein, Rheinland-Pfalz, 67059, Germany|Schwerpunktpraxis Diabetes, Saint Ingbert-Oberwürzbach, Saarland, 66386, Germany|SMO.MD GmbH, Magdeburg, Sachsen-Anhalt, 39112, Germany|RED-Institut GmbH, Oldenburg in Holstein, Schleswig Holstein, 23758, Germany|Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen, Hamburg, 21073, Germany|Gemeinschaftspraxis für innere Medizin und Diabetologie, Hamburg, 22607, Germany|Kashiwa hospital, Kashiwa, Chiba, 277-0825, Japan|Manda Hospital, Sapporo, Hokkaido, 060-0062, Japan|Takai Naika Clinic, Kamakura, Kanagawa, 247-0056, Japan|Takatsuki Red Cross Hospital, Takatsuki, Osaka, 569-1096, 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|The Institute for Adult Diseases, Asahi Life Foundation, Chuou-ku, Tokyo, 1030002, Japan|Sato Naika Clinic, Ota-ku, Tokyo, 143-0015, Japan|Jinnouchi Hospital, Kumamoto, 862-0976, Japan|Centrum Medyczne AMED, Warszawa, Mazowieckie, 01-518, Poland|NZOZ ZDROWIE Osteo-Medic, Bialystok, Podlaskie, 15-351, Poland|Centrum Badan Klinicznych, PI House, Gdansk, Pomorskie, 80-546, Poland|NZOZ Przychodnia Specjalistyczna MEDICA, Lublin, 20-538, Poland|Centro de Endocrinologia y Nutricion del Turabo, Caguas, 00725, Puerto Rico|Manati Center for Clinical Research Inc, Manati, 00674, Puerto Rico|Ambulancia vnútorného lekárstva Hnúša (Diabetes care), Hnusta, 98101, Slovakia|Sin Azucar, Malacky, 901 01, Slovakia|Dia-Clarus.s.r.o., Prievidza, 971 01, Slovakia|JAL, Trnava, 917 01, Slovakia|Medivasa, s.r.o., Zilina, 01001, Slovakia|Hospital Clinico Universitario Virgen de la Victoria, Malaga, Andalucia, 29010, Spain|Hospital de la Ribera, Alcira, Valencia, 46600, Spain|Hospital Universitario Virgen Macarena, Sevilla, 41009, Spain|Hospital Infanta Luisa, Sevilla, 41010, Spain|Hospital Universitari i Politecnic La Fe-ENDO, València, 46026, Spain
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