A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tirzepatide

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.