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

NCT ID: NCT07239440

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Diabete Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DA-2811

DA-2811 + DA-2811-R2

Group Type EXPERIMENTAL

DA-2811

Intervention Type DRUG

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

DA-2811-C

DA-2811-C + DA-2811-R1

Group Type EXPERIMENTAL

DA-2811-C

Intervention Type DRUG

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

Interventions

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DA-2811

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

Intervention Type DRUG

DA-2811-C

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Facility Contacts

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Jae Hyeon Kim

Role: primary

Other Identifiers

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DA2811_DMLD_II

Identifier Type: -

Identifier Source: org_study_id

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