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NCT Number: NCT07229534

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

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

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Key information

Conditions

Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-5218

Drug

DA-5218 + DA-5218-C placebo

DA-5218-C

Drug

DA-5218-C + DA-5218 placebo

Primary outcomes

  1. Change from baseline of HbA1c(%)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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