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

NCT02500329 | Unknown Phase 4

• 1 other identifier: BRMH 26-2014-124
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Function; Type 2 Diabetes; Gemigliptin; Acarbose

Outcome Measures

Primary Outcomes (1)

• endothelial function (reactive hyperemic index)

  4 weeks

Secondary Outcomes (3)

• Fasting plasma glucose

  4 weeks

• Postprandial 2hour glucose

  4 weeks

• Glycated albumin

  4 weeks

Study Arms (2)

gemigliptin

EXPERIMENTAL

gemigliptin for 4 weeks

Drug: Gemigliptin

acarbose

ACTIVE COMPARATOR

acarbose for 4 weeks

Drug: Acarbose

Interventions

Gemigliptin DRUG

Gemigliptin for 4 weeks

gemigliptin

Acarbose DRUG

Acarbose for 4 weeks

acarbose

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Boramae medical center

Seoul, 156-707, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444; Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Min Kyong Moon

  Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Kyong Moon

CONTACT

+82-2-870-2226; mkmoon@snu.ac.kr

Bo Kyung Koo

CONTACT

+82-2-870-2225; bokyungkoomd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 16, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

KR (1)