Patients with major Adverse Events With Type 2 Diabetes
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2020/04/024938
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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)
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method