A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin (J2A-MC-GZGU)
- Conditions
- Type 2 Diabetes
- Registration Number
- jRCT2041230086
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 1576
Have Type 2 Diabetes Have HbA1c >=7.0% (53 mmol/mol) to <=10.5% (91 mmol/mol), as determined by the central laboratory at screening. Have been on stable diabetes treatment with metformin >=1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization. Are of stable body weight (+-5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment
Have Type 1 Diabetes Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors. Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization. Have a New York Heart Association functional classification IV congestive heart failure. Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening. Have a serum calcitonin level of >=35 nanogram/Liter (ng/L), as determined by the central laboratory at screening. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 52 ]
- Secondary Outcome Measures
Name Time Method