Status:
UNKNOWN
Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
Lead Sponsor:
Dokkyo Medical University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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 g...
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 5 % ≤ fasting FMD at baseline \< 8.0 %
Exclusion
- ・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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02301806
Start Date
January 1 2015
End Date
July 1 2017
Last Update
February 17 2016
Active Locations (2)
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1
Dokkyo Medical University
Mibu, Tochigo, Japan, 321-0293
2
Mibu, Japan