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

Korábbi kezelés

• 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.

Más betegség

• Have New York Heart Association functional classification III-IV 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

Egyéb

• Have had chronic or acute pancreatitis any time.

• 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.