A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
Purpose
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.
Condition
- Type 2 Diabetes Mellitus
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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/m²)
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 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 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) - 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Tirzepatide |
Tirzepatide administered subcutaneously (SC) once a week. |
|
Active Comparator Dulaglutide |
Dulaglutide administered SC once a week. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company