A Phase III study to investigate the efficacy and safety of elecoglipron compared with placebo in adults with type 2 diabetes mellitus on background insulin - Eluminate-3

Inclusion Criteria

• Inclusion Criteria:
• - Diagnosed with T2DM for at least 90 days prior to screening
• - Stable treatment with background insulin and other background glucose-lowering medication(s)
• - HbA1c value of ≥ 7% to ≤ 10.5%
• - Body mass index (BMI) of ≥ 23 kg/m2 at screening
• - Stable body weight (self-reported or documented) for 90 days prior to screening
• Exclusion Criteria:
• - T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
• - Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
• - Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
• - Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
• - History of acute or chronic pancreatitis.
• - Severe congestive heart failure (NYHA IV)
• - History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2