Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM

February 15, 2016 updated by: Yoshimasa Aso, Dokkyo Medical University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Mibu, Japan
        • Recruiting
    • Tochigo
      • Mibu, Tochigo, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University
        • Contact:
        • Principal Investigator:
          • Yoshimasa Aso, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin
sitagliptin 50 mg tablet by mouth 12 weeks
Other: dieting
Drug: Sitagliptin
sitagliptin 50 mg tablet by mouth 12 weeks
Active Comparator: Glimepiride
glimepiride 1 mg tablet by mouth 12 weeks
Other: dieting
Drug: Glimepiride
glimepiride 1 mg tablet by mouth 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change in the number of EPCs after 12-week treatment
Time Frame: 12 weeeks
12 weeeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokkyo Medical University

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Yoshimasa Aso, Dokkyo Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

November 22, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-282-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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