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NCT06290349Not yet recruiting

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
Dong-A ST Co., Ltd.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Type 2 Diabetes
Drug/Device/Intervention
DA5221-T1
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Dong-A ST Co., Ltd.
Location
Seoul, South Korea
Timeline & enrollment
Phase
Phase 3
Start date
Feb 28, 2024
End date
Nov 30, 2025
Enrollment
162 participants
Primary outcome

Change from the baseline in HbA1c (%) after 24 weeks

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.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06290349
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06290349 through Pure Global AI's free database. This Phase 3 trial is sponsored by Dong-A ST Co., Ltd. and is currently Not yet recruiting. The study focuses on Type 2 Diabetes. Target enrollment is 162 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.