A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
- Conditions
- Diabetes Type 2Glucose Metabolism DisordersEndocrine System DiseasesMetabolic DiseaseDiabetes Mellitus
- Interventions
- Drug: Placebo
- Registration Number
- NCT05691712
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mg Tirzepatide Tirzepatide 10 mg tirzepatide administered SC once a week. Placebo Placebo Participants will receive a tirzepatide matched placebo. 15 mg Tirzepatide Tirzepatide 15 mg tirzepatide administered SC once a week. 5 mg Tirzepatide Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
- Primary Outcome Measures
Name Time Method Mean Change from Baseline in HbA1c (Tirzepatide 10 or 15 milligram [mg]) Baseline, Week 40
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Weight Loss of ≥5% Week 40 Percentage of Participants Who Achieved Weight Loss of ≥10% Week 40 Percentage of Participants Who Achieved Weight Loss of ≥15% Week 40 Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 10 mg or 15 mg] Week 40 Percentage of Participants with HbA1c <7.0% (53 millimole/mole [mmol/mol]) and ≤6.5% (48 mmol/mol) Week 40 Mean Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles Baseline, Week 40 Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 5 mg] Week 40 Percentage of Participants with HbA1c <7.0%, Without Weight Gain (<0.1 kilogram [kg]) and Without Hypoglycemia, (Blood glucose <3.0 mmol/L <54 milligram/deciliter [mg/dL]) Week 40 Mean Change from Baseline in HbA1c (Tirzepatide 5 mg) Baseline, Week 40 Mean Change from Baseline in Body Weight Baseline, Week 40 Mean Change from Baseline in Fasting Serum Glucose Baseline, Week 40 Percentage Change from Baseline in Daily Mean Insulin Glargine Dose Baseline, Week 40 Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.0 mmol/L [54 mg/dL]) Week 40 Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia) Week 40 Percentage of Participants with HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.9 mmol/L [70 mg/dL] or Severe hypoglycemia) Week 40
Trial Locations
- Locations (25)
The Second People's Hospital of Hefei
🇨🇳Hefei, Anhui, China
The First Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳LuoyangShi, Henan, China
Baotou Central Hospital
🇨🇳Baotou, Inner Mongolia, China
The First People's Hospital of Yueyang
🇨🇳Yueyang, Hunan, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
🇨🇳WuxiShi, Jiangsu, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Chengdu Fifth People's Hospital
🇨🇳Chengdu, Sichuan, China
Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, Guangdong, China
The Fourth Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, Jiangsu, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing Pinggu District Hospital
🇨🇳Beijing, Beijing, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The Third Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
West China Hospital of Sichuan University
🇨🇳ChengDu, Sichuan, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shaanxi, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China