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
NCT ID: NCT05743907
Last Updated: 2025-03-14
Study Results
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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COMPLETED
PHASE4
231 participants
INTERVENTIONAL
2023-04-25
2025-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DA-2811
DA-2811 + Forxiga placebo
DA-2811
DA-2811 Group: DA-2811 + Forxiga placebo
Forxiga
Forxiga + DA-2811 placebo
Forxiga
Forxiga Group: Forxiga + DA-2811 placebo
Interventions
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DA-2811
DA-2811 Group: DA-2811 + Forxiga placebo
Forxiga
Forxiga Group: Forxiga + DA-2811 placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, , South Korea
Countries
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Other Identifiers
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DA2811_DM_IV
Identifier Type: -
Identifier Source: org_study_id
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