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

Phase 4

• Conditions: Type 2 Diabetes; Gemigliptin; Acarbose; Endothelial Function
• Interventions: Drug: Gemigliptin; Drug: Acarbose

• Registration Number: NCT02500329
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-07
• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gemigliptin	Gemigliptin	gemigliptin for 4 weeks
acarbose	Acarbose	acarbose for 4 weeks

Primary Outcome Measures

Name	Time	Method
endothelial function (reactive hyperemic index)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Postprandial 2hour glucose	4 weeks
Glycated albumin	4 weeks
Fasting plasma glucose	4 weeks

Trial Locations

Locations (1)

Boramae medical center; 🇰🇷 Seoul, Korea, Republic of