Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Empagliflozin as Add-On Therapy with Metformin and Alogliptin for Type 2 Diabetes
Led by Celltrion · Updated on 2025-08-11
171
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults at the time of signing the Informed Consent Form
- Signed the written informed consent form voluntarily after being fully informed about the study
- Diagnosed with type 2 diabetes mellitus (T2DM)
You will not qualify if you...
- Diagnosed with types of diabetes other than type 2 diabetes mellitus
- History of hypersensitivity to components or drugs similar to the investigational product or background therapy
- Uncontrolled severe complications of diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive add-on therapy with empagliflozin alongside metformin and alogliptin for type 2 diabetes management.
Regular visits during 24 weeks of treatment
Trial Site Locations
Total: 1 location
1
Celltrion
Seoul, South Korea
Actively Recruiting
Research Team
C
Celltrion, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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