A Clinical Trial to Evaluate the Preference Regarding Convenience of Medication and Efficacy/Safety of SUGAMET®XR Tablet 5/1000mg
NCT ID: NCT04653779
Last Updated: 2020-12-11
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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UNKNOWN
PHASE4
54 participants
INTERVENTIONAL
2020-12-31
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A
Patients receive Evogliptin 5mg/Metformin 1000mg once a day
Evogliptin 5mg/Metformin 1000mg
Size reduction of a tablet formulation
Interventions
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Evogliptin 5mg/Metformin 1000mg
Size reduction of a tablet formulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with type 2 diabetes mellitus
* Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening
* Subjects with HbA1c≤7.5% at screening
* Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening
* Subjects with fasting glucose≤200 at screening
* Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
Exclusion Criteria
* ESRD or Patients who have kidney dialysis
* Subjects with ALT and AST 3 times or higher than upper normal range
60 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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Suncheonhyang Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Se-jong hospital
Bucheon-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Suncheonhyang Bucheon Hospital
Role: primary
Se-jong hospital
Role: primary
Other Identifiers
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DA1229_01_DM_IV
Identifier Type: -
Identifier Source: org_study_id