A Study of LY3502970 Versus Insulin Glargine in Adult Participants with Type 2 Diabetes and Obesity or Overweight
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2023/10/058480
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Have been diagnosed with type 2 diabetes mellitus (T2DM)
2. Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
3. Have HbA1c at screening of =7.0% and =10.5% if background diabetes medication does not include a sulfonylurea, or =7.5% and =10.5% if background diabetes medication includes a sulfonylurea.
4. Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas
5. Have increased risk for cardiovascular (CV) events due to: Coronary heart disease, Peripheral arterial disease, presumed to be of atherosclerotic origin, Cerebrovascular disease, presumed to be of atherosclerotic origin, Chronic kidney disease (CKD), Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
6. Are of stable weight (± 5%) for at least 90 days prior to screening
7. Have a BMI =25 kilograms per meter squared (kg/m2) at screening
1. Have type 1 diabetes mellitus
2. Have had chronic or acute pancreatitis any time prior to screening
3. Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
4. Have a known clinically significant gastric emptying abnormality
5. Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level =5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory
6. Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
7. Have an eGFR <15 mL/min/1.73 m2 as determined at screening
8. Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
9. Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days
10. Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]Timepoint: Baseline to End of the Study (Approximate Maximum 104 Weeks)
- Secondary Outcome Measures
Name Time Method 1. Change from Baseline in HbA1c <br/ ><br>2. Change from Baseline in Fasting Serum Glucose <br/ ><br>3. Change from Baseline in Daily Average 7-point SMBG <br/ ><br>4. Change from Baseline in Body Weight <br/ ><br>5. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain ScoreTimepoint: Baseline, Week 52;1. Percentage of Participants with HbA1c Target Values Less Than 7.0% (53 mmol/mol) <br/ ><br>2. Percent Change from Baseline Body WeightTimepoint: Week 52;Pharmacokinetics (PK): Plasma Serum Concentrations of OrforglipronTimepoint: Baseline through Week 52;Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)Timepoint: Baseline to End of the Study (Approximately 104 Weeks)