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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

NCT06290349 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-11-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-09-05
Completion
2026-03-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06290349 on ClinicalTrials.gov