A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants Wit… (NCT05803421) | Clinical Trial Compass
CompletedPhase 3
A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
United States2,749 participantsStarted 2023-04-03
Plain-language summary
The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* 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.
* Have HbA1c at screening
* ≥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.
* 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
* 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
* Are of stable weight (± 5%) for at least 90 days prior to screening
* Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
Exclusion Criteria:
* Have type 1 diabetes mellitus
* Have had chronic or acute pancreatitis any time prior to screening
* 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
* Have a known clinically significant gastric emptying abnormalit…
What they're measuring
1
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
Timeframe: Baseline to End of the Study (Approximate Maximum 104 Weeks)