NCT06290349

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	DA5221-T1	DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks
DRUG	DA5221-T2	DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks
DRUG	Placebo	DA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks
DRUG	DA5221-B1	DA5221-B1, orally, daily for background therapy
DRUG	DA5221-B2	DA5221-B2, orally, daily for background therapy

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-09-05
• Completion: 2026-03-31
• First posted: 2024-03-04
• Last updated: 2025-11-19

Locations

1 site across 1 country: South Korea