A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron compared with Placebo in Adults with Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)

Condition studied

type 2 diabetes mellitus

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change from baseline to Week 40 in HbA1c (%)

Endpoint detail

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), Change from baseline to Week 40 in SBP, Achieved HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia) at Week 40, Change from baseline to Week 40 in FPG, Time to initiation of rescue medication over 40 weeks, Change from baseline to Week 40 in DBP