Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes

NCT ID: NCT07229534

Last Updated: 2025-11-17

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

PHASE4

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-11-30

Brief Summary

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This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-5218 in patients with type 2 diabetes who have inadequate glycemic control with metformin

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DA-5218

Group Type EXPERIMENTAL

DA-5218

Intervention Type DRUG

DA-5218 + DA-5218-C placebo

DA-5218-C

Group Type ACTIVE_COMPARATOR

DA-5218-C

Intervention Type DRUG

DA-5218-C + DA-5218 placebo

Interventions

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DA-5218

DA-5218 + DA-5218-C placebo

Intervention Type DRUG

DA-5218-C

DA-5218-C + DA-5218 placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 7.0%≤HbA1c≤10.5% and fasting glucose≤270mg/dL
* Treated with 1,000mg/day dose of metformin for at least 8 weeks

Exclusion Criteria

* Type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* eGFR\<45mL/min/1.73m2
* ALT and AST 3 times or higher than upper normal range
* Determined by investigator as unfit to participate in a clinical trial due to other reasons
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

Other Identifiers

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DA5218_DMSD_IV

Identifier Type: -

Identifier Source: org_study_id

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