Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
917 Patients enrolled
Trial Details
Trial ID
NCT04093752
Start Date
December 9 2019
End Date
November 24 2021
Last Update
January 6 2023
Active Locations (67)
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1
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia, 2148
2
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia, 2259
3
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
4
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, Australia, 2500