A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea

17210

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

2019-12-09

2021-11-01

2021-11-24

Completed

Early phase I

917

Inclusion Criteria: * Type 2 diabetes mellitus * Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months * Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use \[≤14 consecutive days\] for acute conditions) * HbA1c ≥7.5% to ≤11.0% at screening * Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment * Body mass Index (BMI) ≥23 kilograms per meter squared Exclusion Criteria: * Type 1 diabetes mellitus * Have history of chronic or acute pancreatitis * Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment * Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months * Have a history of ketoacidosis or hyperosmolar state/coma * Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility * Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 917, 'type': 'ACTUAL'}}

2023-01-06