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

  • STATUS
    Recruiting
  • End date
    Feb 2, 2022
  • participants needed
    956
  • sponsor
    Eli Lilly and Company
Updated on 24 November 2020
insulin
body mass index
type 2 diabetes mellitus
metformin
hemoglobin a1c
drug test
sulfonylurea

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.

Details
Treatment Insulin glargine, Tirzepatide
Clinical Study IdentifierNCT04093752
SponsorEli Lilly and Company
Last Modified on24 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Mellitus Types I and II or Diabetes Mellitus, Type 2 or Diabetes Mellitus or Diabetes Mellitus Type 2 or NIDDM or Diabetes Prevention or Diab...?
Do you have any of these conditions: noninsulin-dependent diabetes mellitus or NIDDM or Diabetes (Pediatric) or Diabetes Mellitus or Diabetes Mellitus, Type 2 or type 2 diabetes mellitus ...?
Do you have any of these conditions: noninsulin-dependent diabetes mellitus or diabetes type 2 or NIDDM or type ii diabetes or Diabetes Mellitus, Type 2 or Diabetes Prevention or Diabetes...?
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
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