Effect of Gemigliptin or Acarbose on Endothelial Function in Type 2 DM Patients

NCT ID: NCT02500329

Last Updated: 2015-07-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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This is a phase 4, single center, randomized, open-labeled study. The primary objective of the study is to compare effect of gemigliptin and acarbose on endothelial function.

Subjects are randomized to gemigliptin or acarbose group and maintained intial treatment for 4 weeks.

Detailed Description

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Conditions

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Endothelial Function Type 2 Diabetes Gemigliptin Acarbose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gemigliptin

gemigliptin for 4 weeks

Group Type EXPERIMENTAL

Gemigliptin

Intervention Type DRUG

Gemigliptin for 4 weeks

acarbose

acarbose for 4 weeks

Group Type ACTIVE_COMPARATOR

Acarbose

Intervention Type DRUG

Acarbose for 4 weeks

Interventions

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Gemigliptin

Gemigliptin for 4 weeks

Intervention Type DRUG

Acarbose

Acarbose for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age: 20-80yrs
* 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

* patients with type 1 diabetes
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Min Kyong Moon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Min Kyong Moon

Role: CONTACT

+82-2-870-2226

Bo Kyung Koo

Role: CONTACT

+82-2-870-2225

Facility Contacts

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Bokyung Koo

Role: primary

Other Identifiers

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BRMH 26-2014-124

Identifier Type: -

Identifier Source: org_study_id

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