About this trial
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Eligibility criteria
Qualifiers
Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
Body mass index (BMI) of ≥ 23 kg/m2 at screening
Disqualifiers
Type 1 Diabetes, 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
Trial design
Treatments tested in this trial
- Elecoglipron
- Dapagliflozin
- Elecoglipron-matched placebo
- Dapagliflozin-matched placebo