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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02500329

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Endothelial Function Type 2 Diabetes Gemigliptin Acarbose	Drug: Gemigliptin Drug: Acarbose	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Gemigliptin or Acarbose on Endothelial Function in Type 2 DM Patients (GetUp Trial)

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gemigliptin gemigliptin for 4 weeks	Drug: Gemigliptin Gemigliptin for 4 weeks
Active Comparator: acarbose acarbose for 4 weeks	Drug: Acarbose Acarbose for 4 weeks

Arm

Intervention/Treatment

Experimental: gemigliptin

gemigliptin for 4 weeks

Drug: Gemigliptin

Gemigliptin for 4 weeks

Active Comparator: acarbose

acarbose for 4 weeks

Drug: Acarbose

Acarbose for 4 weeks

Outcome Measures

Primary Outcome Measures

endothelial function (reactive hyperemic index) [4 weeks]

Secondary Outcome Measures

Fasting plasma glucose [4 weeks]
Postprandial 2hour glucose [4 weeks]
Glycated albumin [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boramae medical center	Seoul		Korea, Republic of	156-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Min Kyong Moon, Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Min Kyong Moon, Associate Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02500329

Other Study ID Numbers:

BRMH 26-2014-124

First Posted:

Jul 16, 2015

Last Update Posted:

Jul 16, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Acarbose

Study Results

No Results Posted as of Jul 16, 2015