Trial | NCT02301806  Report issue

Title

Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
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 Started
Jan 31
2015
Primary Completion
Jun 30
2017
Anticipated
Study Completion
Jul 31
2017
Anticipated
Last Update
Feb 17
2016
Estimate

Other dieting

Drug Sitagliptin

sitagliptin 50 mg tablet by mouth 12 weeks

Drug Glimepiride

glimepiride 1 mg tablet by mouth 12 weeks

Sitagliptin Experimental

sitagliptin 50 mg tablet by mouth 12 weeks

Glimepiride Active Comparator

glimepiride 1 mg tablet by mouth 12 weeks

Criteria 

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
No Results Posted