NCT07239440

Brief Summary

This study is a multicenter, double-blind, active-controlled, randomized, parallel clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing BT-1 and BT-2 combination therapy in patients with type 2 diabetes who have inadequate glycemic control

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for phase_2

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Nov 2025Jun 2027

Study Start

First participant enrolled

November 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Diabete Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change from baseline at 12 weeks

Secondary Outcomes (1)

  • HbA1c

    Change from baseline at 24 weeks

Study Arms (2)

DA-2811

EXPERIMENTAL

DA-2811 + DA-2811-R2

Drug: DA-2811

DA-2811-C

EXPERIMENTAL

DA-2811-C + DA-2811-R1

Drug: DA-2811-C

Interventions

DA-2811DRUG

DA-2811 + DA-2811-R2, orally, once daily

DA-2811
DA-2811-CDRUG

DA-2811-C + DA-2811-R1, orally, once daily

DA-2811-C

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 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)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

KR(1)