A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin
NCT ID: NCT02946541
Last Updated: 2017-03-28
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
PHASE3
160 participants
INTERVENTIONAL
2013-07-31
2015-04-30
Brief Summary
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Detailed Description
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2. Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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evogliptin 5mg
evogliptin 5mg QD
evogliptin 5mg
evogliptin 5mg, QD
placebo
Placebo QD
Placebo
Placebo, QD
Interventions
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evogliptin 5mg
evogliptin 5mg, QD
Placebo
Placebo, QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening
* Subjects with 6.5%≤HbA1c≤10.0% at Visit 2
* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
Exclusion Criteria
* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
* Subjects with ALT and AST 2.5 times or higher than upper normal range
18 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Doo Man Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kangdong Sacred Heart Hospital
Locations
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Kangdong Sacred Heart Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DA1229_DMM_III
Identifier Type: -
Identifier Source: org_study_id
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