Effect of Gemigliptin or Acarbose on Endothelial Function in Type 2 DM Patients
NCT ID: NCT02500329
Last Updated: 2015-07-16
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
2014-09-30
Brief Summary
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Subjects are randomized to gemigliptin or acarbose group and maintained intial treatment for 4 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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gemigliptin
gemigliptin for 4 weeks
Gemigliptin
Gemigliptin for 4 weeks
acarbose
acarbose for 4 weeks
Acarbose
Acarbose for 4 weeks
Interventions
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Gemigliptin
Gemigliptin for 4 weeks
Acarbose
Acarbose for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* patients with type 2 diabetes (duration of diabetes \>=3 months)
* HbA1c :\>7.0 and \<=9.0% on metformin monotherapy
* no changes on medications during recent 3 months.
Exclusion Criteria
* history of medications including α-glucosidase inhibitor, glinide, GLP-1 analogue, other DPP-4 Inhibitors, or insulin during recent 3 months.
* history of acute diabetic complication, acute coronary events, or coronary bypass surgery/interventions during recent 6 months.
* patients with congestive heart failure (NYHA II\~IV) or clinically significant ventricular arrhythmia
* serum ALT or AST\> 2.5 x upper normal range
* serum direct bilirubin \> 1.3 x upper normal range
* serum creatinine \> (men) 1.5 mg/dL, (women)\>1.4 mg/dL
* smoker
* pregnant women, or breast-feeding women
* medication with acetylsalicylic acid or vitamin K antagonist
20 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Min Kyong Moon
Associate Professor
Principal Investigators
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Min Kyong Moon
Role: PRINCIPAL_INVESTIGATOR
Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
Locations
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Boramae medical center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRMH 26-2014-124
Identifier Type: -
Identifier Source: org_study_id
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