NCT02301806

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Dokkyo Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	dieting
DRUG	Sitagliptin	sitagliptin 50 mg tablet by mouth 12 weeks
DRUG	Glimepiride	glimepiride 1 mg tablet by mouth 12 weeks

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2014-11-26
• Last updated: 2016-02-17

Locations

2 sites across 1 country: Japan