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NCT Number: 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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance Hospital, Yonsei University college of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with type II diabetes mellitus aged 19 years or older
  • Patients who had taken DA5221-B1 and DA5221-B2(or another DPP-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit
  • Patients with fasting plasma glucose≤270mg/dL at the screening visit
  • Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
  • Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion criteria

  • Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
  • Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
  • Patients with severe infectious disease or severe traumatic systemic disorders
  • Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
  • Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption

Treatment and study plan

DA5221-T1

Drug

DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks

DA5221-T2

Drug

DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks

Placebo

Drug

DA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks

DA5221-B1

Drug

DA5221-B1, orally, daily for background therapy

DA5221-B2

Drug

DA5221-B2, orally, daily for background therapy

Primary outcomes

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

    Time frame: Baseline, 24 weeks

Secondary outcomes

  1. Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks

    Time frame: Baseline, 24 weeks

  2. Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks

    Time frame: Baseline, 24 weeks

  3. Change from the baseline in weight after 24 weeks

    Time frame: Baseline, 24 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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