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

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide 		Tirzepatide administered subcutaneously (SC) once a week.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Active Comparator
Dulaglutide 		Dulaglutide administered SC once a week.
  • Drug: Dulaglutide
    Administered SC
    Other names:
    • LY2189265

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Study Contact