Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Tirzepatide: Tirzepatide administered subcutaneously (SC) once a week upto 24 weeks
Starting dosage should be 2.5 mg to be escalated to 15 mg.
Control Intervention1: Dulaglutide: Dulagl
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have a diagnosis of type 2 diabetes 2. Have confirmed atherosclerotic cardiovascular disease 3. HbA1c =7.0% to =10.5% 4. Body mass index (BMI) =25 kilograms per meter squared (kg/m²)
Exclusion criteria
Exclusion criteria: 1. Have had a major cardiovascular event within the last 60 days 2. Have type 1 diabetes mellitus 3. Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months 4. Have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment 5. Currently planning a coronary, carotid, or peripheral artery revascularization 6. Have a history of pancreatitis 7. Have a history of ketoacidosis or hyperosmolar state/coma 8. 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 9. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years 10. Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)Timepoint: Randomization up to Study Completion (Approximate Maximum 54 Months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Body Weight Change from Baseline in Hemoglobin A1c (HbA1c) Change from Baseline in Urinary Albumin to Creatinine Ratio Change from Baseline in Blood LipidsTimepoint: Baseline, End of Study (Approximate Maximum 54 Months);Cumulative Number of Primary Composite Events of CV Death and Total (First and Recurrent) MI and/or Stroke Cumulative Number of CV Deaths and Total (First and Recurrent) Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure VisitsTimepoint: End of Study (Approximate Maximum 54 Months);Percentage of Participants with More than 10% Weight LossTimepoint: 36 Months;Time to Death from Any Cause Time to CV Death Time to First Occurrence of MI Time to First Occurrence of Stroke Timepoint: Randomization up to Study Completion (Approximate Maximum 54 Months);Time to First Occurrence of Revascularization Time to First Occurrence of Hospitalization Due to Unstable Angina Time to First Occurrence of New or Worsening Nephropathy Time to CV Death, MI, Stroke, Coronary Revascularization, or Hospitalization for Unstable AnginaTimepoint: Randomization up to Study Completion (Approximate Maximum 54 Months) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd.
Outcome results
None listed