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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Endothelial Function; Gemigliptin; Acarbose; Type 2 Diabetes

Treatments: Drug: Gemigliptin; Drug: Acarbose

Study type: Interventional

Funder types: Other

Identifiers

NCT02500329

BRMH 26-2014-124

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

gemigliptin

Experimental group

Description:

gemigliptin for 4 weeks

Treatment:

Drug: Gemigliptin

acarbose

Active Comparator group

Description:

acarbose for 4 weeks

Treatment:

Drug: Acarbose