Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM

NCT02301806 | Unknown Phase 4 DMC

• 1 other identifier: C-282-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (1)

• Change in the number of EPCs after 12-week treatment

  12 weeeks

Study Arms (2)

Sitagliptin

EXPERIMENTAL

sitagliptin 50 mg tablet by mouth 12 weeks

Other: dieting; Drug: Sitagliptin

Glimepiride

ACTIVE COMPARATOR

glimepiride 1 mg tablet by mouth 12 weeks

Other: dieting; Drug: Glimepiride

Interventions

dieting OTHER

Glimepiride; Sitagliptin

Sitagliptin DRUG

sitagliptin 50 mg tablet by mouth 12 weeks

Sitagliptin

Glimepiride DRUG

glimepiride 1 mg tablet by mouth 12 weeks

Glimepiride

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % ≤ fasting FMD at baseline \< 8.0 %

You may not qualify if:

• ・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

Sponsors & Collaborators

• Dokkyo Medical University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Dokkyo Medical University

Mibu, Tochigo, 321-0293, Japan

RECRUITING

Unknown Facility

Mibu, Japan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Yoshimasa Aso

  Dokkyo Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshimasa Aso, MD

CONTACT

81-282-86-1111; yaso@dokkyomed.ac.jp

Kunihiro Suzuki, MD

CONTACT

81-282-86-1111; kuni-s@dokkyomed.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 22, 2014
• First Posted: November 26, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

JP (2)