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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06290349

Enrollment

174

Registered

2024-03-04

Start date

2024-04-01

Completion date

2026-03-31

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief 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.

Interventions

DRUGDA5221-T1

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

DRUGDA5221-T2

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

DRUGPlacebo

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

DRUGDA5221-B1

DA5221-B1, orally, daily for background therapy

DRUGDA5221-B2

DA5221-B2, orally, daily for background therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with type II diabetes mellitus aged 19 years or older 2. 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 3. Patients with fasting plasma glucose≤270mg/dL at the screening visit 4. Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit 5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion criteria

1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis 2. 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 3. Patients with severe infectious disease or severe traumatic systemic disorders 4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia 5. Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption

Design outcomes

Primary

Measure	Time frame
Change from the baseline in HbA1c (%) after 24 weeks	Baseline, 24 weeks

Secondary

Measure	Time frame
Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks	Baseline, 24 weeks
Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks	Baseline, 24 weeks
Change from the baseline in weight after 24 weeks	Baseline, 24 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026