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)
AstraZeneca
Summary
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) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening * On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s) * HbA1c value: 1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol) 2. SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol) * Impaired renal function * 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: * Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosi…
Interventions
- DrugElecoglipron
Elecoglipron is administered orally once daily.
- DrugPlacebo
Placebo is administered orally once daily.
Locations (185)
- Research SitePeoria, Arizona
- Research SiteSurprise, Arizona
- Research SiteConcord, California
- Research SiteSacramento, California
- Research SiteVictorville, California
- Research SiteFleming Island, Florida