Phase 3 Trial Comparing Elecoglipron and Dapagliflozin Combination Versus Each Drug Alone in Adults with Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus