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 12 September 2021
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
Condition NIDDM, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Dulaglutide, Tirzepatide
Clinical Study IdentifierNCT04255433
SponsorEli Lilly and Company
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Are currently planning treatment for diabetic retinopathy and/or macular edema
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 history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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