A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor (J2A-MC-GZGW)
- Conditions
- Type 2 Diabetes
- Registration Number
- jRCT2031230504
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 520
Have Type 2 Diabetes (T2D) Have HbA1c>=7.0% [53 mmol/mol] to <=10.5% [91 mmol/mol] Have been treated with stable doses of the same formulation of the following for >=90 days prior to screening visit 1 and have maintained the same doses through randomization:
insulin glargine U-100 (100 U/mL) >=0.20 U/kg/QD (units per kilogram per day) or >=15 U/QD alone, or insulin glargine U-100 (100 U/mL)>=0.20 U/kg/QD or >=15 U/QD in combination with metformin, or SGLT-2 inhibitor. Are of stable body weight (+-5%) for at least 90 days prior to screening visit 1 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 a Body Mass Index (BMI) >=23.0 kg/m^2 at baseline.
Have New York Heart Association functional classification III-IV congestive heart failure. Have had any of the following cardiovascular conditions within 60 days prior to baseline.
acute myocardial infarction cerebrovascular accident (stroke), or hospitalization for congestive heart failure. Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease Have had chronic or acute pancreatitis any time.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40 Orforglipron Dose 1, 2
- Secondary Outcome Measures
Name Time Method