A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

• Status: Active, not recruiting
• Trial end date: 2021-11-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin; Tirzepatide

Criteria

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 infaction (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