A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

  • STATUS
    Recruiting
  • End date
    Oct 17, 2024
  • participants needed
    12500
  • sponsor
    Eli Lilly and Company
Updated on 25 November 2020
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
MedStar Health Research Institute (1.7 mi away) Contact
+807 other location
cardiovascular disease
body mass index
hemoglobin a1c

Summary

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Details
Treatment Dulaglutide, Tirzepatide
Clinical Study IdentifierNCT04255433
SponsorEli Lilly and Company
Last Modified on25 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 40 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 diabetes type 2 or NIDDM or type ii diabetes or Diabetes Mellitus, Type 2 or Diabetes Prevention or Diabetes...?
Have a diagnosis of type 2 diabetes
Have confirmed atherosclerotic cardiovascular disease
HbA1c 7.0% to 10.5%
Body mass index (BMI) 25 kilograms per meter squared (kg/m)

Exclusion Criteria

Have had a major cardiovascular event within the last 60 days
Have type 1 diabetes mellitus
Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
Have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
Currently planning a coronary, carotid, or peripheral artery revascularization
Have a history of pancreatitis
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 gastrointestinal (GI) motility
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
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Step 4 Get your study results

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