NCT06290349

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

Timeline
Completed

Started Apr 2024

Typical duration for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

February 26, 2024

Last Update Submit

November 16, 2025

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    Baseline, 24 weeks

Secondary Outcomes (3)

  • 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

Study Arms (3)

DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2

EXPERIMENTAL
Drug: DA5221-T1Drug: DA5221-B1Drug: DA5221-B2

DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2

EXPERIMENTAL
Drug: DA5221-T2Drug: DA5221-B1Drug: DA5221-B2

DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2

PLACEBO COMPARATOR
Drug: PlaceboDrug: DA5221-B1Drug: DA5221-B2

Interventions

DA5221-T1DRUG

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

DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2
DA5221-T2DRUG

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

DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2
PlaceboDRUG

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

DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2
DA5221-B1DRUG

DA5221-B1, orally, daily for background therapy

DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2
DA5221-B2DRUG

DA5221-B2, orally, daily for background therapy

DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University college of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

April 1, 2024

Primary Completion

September 5, 2025

Study Completion

March 31, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

KR(1)