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Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Sponsor: Dong-A ST Co., Ltd.
Summary
This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy.
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2024-04-01
Completion Date
2026-03-31
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
DA5221-T1
DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks
DA5221-T2
DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks
Placebo
DA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks
DA5221-B1
DA5221-B1, orally, daily for background therapy
DA5221-B2
DA5221-B2, orally, daily for background therapy
Locations (1)
Severance Hospital, Yonsei University college of Medicine
Seoul, South Korea