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

November 16, 2025 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with type II diabetes mellitus aged 19 years or older
  2. Patients with fasting plasma glucose≤270mg/dL at the screening visit
  3. Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
  4. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-2811
DA-2811 + DA-2811-R2
Drug: DA-2811
DA-2811 + DA-2811-R2, orally, once daily
Experimental: DA-2811-C
DA-2811-C + DA-2811-R1
Drug: DA-2811-C
DA-2811-C + DA-2811-R1, orally, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: Change from baseline at 12 weeks
Change from baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: Change from baseline at 24 weeks
Change from baseline at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA2811_DMLD_II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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