Clinical trial NCT02301806: Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Dokkyo Medical University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
Other outcomes:
measure: Change in the number of EPCs after 12-week treatment
timeFrame: 12 weeeks
Locations:
city: Mibu
country: Japan
facility: Dokkyo Medical University
state: Tochigo
city: Mibu
country: Japan
Study officials:
affiliation: Dokkyo Medical University
name: Yoshimasa Aso
role: PRINCIPAL_INVESTIGATOR
References: