Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM

NCT ID: NCT02301806

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-07-31

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sitagliptin

sitagliptin 50 mg tablet by mouth 12 weeks

Group Type: EXPERIMENTAL

dieting

Intervention Type: OTHER

Sitagliptin

Intervention Type: DRUG

sitagliptin 50 mg tablet by mouth 12 weeks

Glimepiride

glimepiride 1 mg tablet by mouth 12 weeks

Group Type: ACTIVE_COMPARATOR

dieting

Intervention Type: OTHER

Glimepiride

Intervention Type: DRUG

glimepiride 1 mg tablet by mouth 12 weeks

Interventions

dieting

Intervention Type: OTHER

Sitagliptin

sitagliptin 50 mg tablet by mouth 12 weeks

Intervention Type: DRUG

Glimepiride

glimepiride 1 mg tablet by mouth 12 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Dokkyo Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yoshimasa Aso

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoshimasa Aso

Role: PRINCIPAL_INVESTIGATOR

Dokkyo Medical University

Locations

Dokkyo Medical University

Mibu, Tochigo, Japan

Site Status: RECRUITING

Mibu, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yoshimasa Aso, MD

Role: CONTACT

yaso@dokkyomed.ac.jp

81-282-86-1111

Kunihiro Suzuki, MD

Role: CONTACT

kuni-s@dokkyomed.ac.jp

81-282-86-1111

Facility Contacts

Yoshimasa Aso, MD

Role: primary

yaso@dokkyomed.ac.jp

81-282-86-1111

Other Identifiers

C-282-02

Identifier Type: -

Identifier Source: org_study_id