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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02500329
• Other study ID #: BRMH 26-2014-124
• Status: Recruiting
• Phase: Phase 4
• First received: July 12, 2015
• Last updated: July 14, 2015
• Start date: September 2014

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: Min Kyong Moon
• Phone: +82-2-870-2226
• Email: mkmoon[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 a-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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acarbose
• Endothelial Function
• Gemigliptin
• Type 2 Diabetes

Intervention

Drug:
• Gemigliptin
Gemigliptin for 4 weeks
• Acarbose
Acarbose for 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Boramae medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function (reactive hyperemic index)		4 weeks	No
Secondary	Fasting plasma glucose		4 weeks	No
Secondary	Postprandial 2hour glucose		4 weeks	No
Secondary	Glycated albumin		4 weeks	No