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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02301806

Enrollment

Registered

2014-11-26

Start date

2015-01-31

Completion date

2017-07-31

Last updated

2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief 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.

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

Interventions

OTHERdieting

DRUGSitagliptin

sitagliptin 50 mg tablet by mouth 12 weeks

DRUGGlimepiride

glimepiride 1 mg tablet by mouth 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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.	12 weeks

Secondary

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.	12 weeks

Other

Measure	Time frame
Change in the number of EPCs after 12-week treatment	12 weeeks

Countries

Japan

Contacts

Primary ContactYoshimasa Aso, MD

yaso@dokkyomed.ac.jp81-282-86-1111

Backup ContactKunihiro Suzuki, MD

kuni-s@dokkyomed.ac.jp81-282-86-1111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026