Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM

Type 2 Diabetes Clinical Trial

Official title:

A Randomized, Prospective, Parallel Design Study to Compare the Effectiveness of Sitagliptin Versus Glimepiride on Endothelial Dysfunction During an Oral Glucose Loading in Drug Naive Patients With Type 2 Diabetes.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02301806
• Other study ID #: C-282-02
• Status: Recruiting
• Phase: Phase 4
• First received: November 22, 2014
• Last updated: February 15, 2016
• Start date: January 2015
• Est. completion date: July 2017

Study information

• Verified date: February 2016
• Source: Dokkyo Medical University
• Contact: Yoshimasa Aso, MD
• Phone: 81-282-86-1111
• Email: yaso[@]dokkyomed.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

To investigate whether single administration of sitaglitpin can restore acute endothelial dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells (EPCs) after oral glucose loading in patients with T2DM.

To compare the effect of sitagliptin and glimepiride on endothelial function evaluated by flow-mediated vasodilatation (FMD) and the number of circulating EPCs in patients with T2DM.

Description:

Acute and chronic improvement of endothelial function is expected through the pleiotropic effect of DPP-4 inhibitors. A randomized, prospective, open-labeled, parallel design. The duration of treatments with sitagliptin or glimepiride is 12 weeks. The number of study centers is a single (Dokkyo Medical University Hospital). Participants will be randomized into the two treatment groups; (a) 50mg sitagliptin (N=15) and (b) 1mg glimepiride (N=15).

Anti-Hyperglycemic effect is expected to be similar according to our study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Provision of informed consent before any study specific procedures

• Type II diabetes who have inadequate glycaemic control (6.5%?HbA1c<9.0%)

• Age from 20 to 80 years old

• No history of using any antihyperglycemic drugs

• No history of cardiovascular complications

• No treatment or treatment with stable doses of lipid-lowering, antihypertensive, and antiplatelet agents for at least 3 months prior to randomization

• 4.5 % = fasting FMD at baseline < 8.0 %

Exclusion Criteria:

• ·Type I diabetes

• Pregnancy

• Liver disease (hepatic enzymes more than three times the upper limit of normal ranges)

• Impairared kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)

• Cigarette smokers

• Contraindications to glimepiride and sitagliptin

• Active proliferative diabetic retinopathy

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• dieting

Drug:
• Sitagliptin
sitagliptin 50 mg tablet by mouth 12 weeks
• Glimepiride
glimepiride 1 mg tablet by mouth 12 weeks

Locations

Country	Name	City	State
Japan	Dokkyo Medical University	Mibu	Tochigo

Sponsors (2)

Lead Sponsor	Collaborator
Dokkyo Medical University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the number of EPCs after 12-week treatment		12 weeeks	No
Primary	Change in endothelial function during the OGTT evaluated by flow-mediated vasodilatation (FMD). The change is defined as below, assuming the peak value and changes of FMD will be observed at t=60 min.		12 weeks	No
Secondary	Change in endothelial function during OGTT* evaluated by endo-PAT. Change in endothelial function after 12-week treatment at the fasting state evaluated by endo-PAT and FMD.		12 weeks	No