A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-INS)
Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders
About this trial
This is an interventional treatment trial for Diabetes Type 2
Eligibility Criteria
Inclusion Criteria: Have type 2 diabetes mellitus (T2DM) Have HbA1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol) Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) Exclusion Criteria: Have type 1 diabetes mellitus (T1DM) Have a history of chronic or acute pancreatitis Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months Have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months Have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF) in the past 2 months Have a serum calcitonin level of ≥35 ng/L, as determined by central laboratory Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >3.0 times the upper limit of normal (ULN), as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
Sites / Locations
- The Second People's Hospital of HefeiRecruiting
- Beijing ChaoYang Hospital
- Beijing Pinggu District HospitalRecruiting
- Chongqing General HospitalRecruiting
- Huizhou Municipal Central HospitalRecruiting
- The First Hospital of Harbin Medical UniversityRecruiting
- The First Affiliated Hospital of Henan University of Science &TechnologyRecruiting
- The Second Affiliated Hospital of Zhengzhou UniversityRecruiting
- The First People's Hospital of YueyangRecruiting
- Baotou Central HospitalRecruiting
- Changzhou No.2 People's HospitalRecruiting
- Nanjing First HospitalRecruiting
- Zhongda Hospital Southeast UniversityRecruiting
- The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
- The Affiliated Jiangyin Hospital of Southeast University Medical CollegeRecruiting
- Wuxi People's HospitalRecruiting
- The Third Hospital of NanchangRecruiting
- Dalian University - The Affiliated Zhongshan Hospital
- The First Affiliated Hospital of Xi'an Medical UniversityRecruiting
- Jinan Central HospitalRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- Chengdu Fifth People's HospitalRecruiting
- Tianjin Medical University General HospitalRecruiting
- Tianjin Medical University Zhu Xianyi Memorial Hospital
- The First People's Hospital of Yunnan Province
- Huzhou Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
5 mg Tirzepatide
10 mg Tirzepatide
15 mg Tirzepatide
Placebo
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10 mg tirzepatide administered SC once a week.
15 mg tirzepatide administered SC once a week.
Participants will receive a tirzepatide matched placebo.