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

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)

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