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Completed

NCT Number: NCT05743907

Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control

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

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Key information

Conditions

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

Primary location

The Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with 7.0%≤HbA1c≤10.0% at screening
  • Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
  • Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
  • Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion criteria

  • Subjects with fasting plasma glucose≥240mg/dL at screening
  • Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
  • Subject with ALT and AST 3 times or higher than upper normal range
  • Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening

Treatment and study plan

DA-2811

Drug

DA-2811 Group: DA-2811 + Forxiga placebo

Forxiga

Drug

Forxiga Group: Forxiga + DA-2811 placebo

Primary outcomes

  1. HbA1c(%)

    Time frame: Change from baseline at 24 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2023
Registry last updated
Mar 14, 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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