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)
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
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
Parallel
Elecoglipron
DrugElecoglipron is administered orally once daily.
Placebo
DrugPlacebo is administered orally once daily.
Change from baseline in Hemoglobin A1c (HbA1c)
Summary statistics
Achieved HbA1c < 7% (53 mmol/mol) at Week 40
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40
Percent change from baseline to Week 40 in body weight
Change from baseline to Week 40 in body weight (kg)
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