Overview
The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.
Eligibility
Inclusion Criteria:
- 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) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
- insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
- metformin, or
- SGLT-2 inhibitor, or
- both metformin and 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.
Exclusion Criteria:
- 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.