Actively Recruiting
Phase 3 Study of Empagliflozin Added to Metformin and Alogliptin for Adults With Type 2 Diabetes Not Controlled by Current Treatment
Led by Celltrion · Updated on 2025-08-11
171
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of adding empagliflozin to the combination therapy of metformin and alogliptin in adults with type 2 diabetes who have insufficient blood sugar control. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to improve management of type 2 diabetes mellitus by assessing this add-on therapy. Participants are randomly assigned to one of three groups metformin plus alogliptin with empagliflozin at one of two different doses, or metformin plus alogliptin alone as the control group. All medications are taken orally once daily. The study also includes an open-label extension phase following the initial treatment period. During the study, participants will be monitored regularly, including measurement of HbA1c levels at 24 weeks to evaluate blood sugar control. Safety and efficacy will be assessed throughout the study, with ongoing follow-up until the study ends in April 2027. Participants will attend scheduled visits for assessments and medication adherence checks.
CONDITIONS
Brief Title
Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
Research Team
C
Celltrion, Inc.
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