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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes; Endothelial Function; Gemigliptin; Acarbose
• Intervention / Treatment: Drug: Gemigliptin; Drug: Acarbose

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Kyong Moon; Phone Number: +82-2-870-2226; Email: mkmoon@snu.ac.kr
• Study Contact Backup: Name: Bo Kyung Koo; Phone Number: +82-2-870-2225; Email: bokyungkoomd@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Recruiting
    • Boramae Medical Center
    • Principal Investigator: Min Kyong Moon
    • Contact: Bokyung Koo; Email: bokyungkoomd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
endothelial function (reactive hyperemic index)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Fasting plasma glucose	4 weeks
Postprandial 2hour glucose	4 weeks
Glycated albumin	4 weeks

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 12, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose
• Other Study ID Numbers: BRMH 26-2014-124