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ACTIVE NOT RECRUITING
NCT06290349
PHASE3

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.

View on ClinicalTrials.gov

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

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

Locations (1)

Severance Hospital, Yonsei University college of Medicine

Seoul, South Korea