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Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM

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ClinicalTrials.gov Identifier: NCT02301806
Recruitment Status : Unknown
Verified February 2016 by Yoshimasa Aso, Dokkyo Medical University.
Recruitment status was:  Recruiting
First Posted : November 26, 2014
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Yoshimasa Aso, Dokkyo Medical University

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: dieting Drug: Sitagliptin Drug: Glimepiride Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sitagliptin
sitagliptin 50 mg tablet by mouth 12 weeks
Other: dieting
Drug: Sitagliptin
sitagliptin 50 mg tablet by mouth 12 weeks

Active Comparator: Glimepiride
glimepiride 1 mg tablet by mouth 12 weeks
Other: dieting
Drug: Glimepiride
glimepiride 1 mg tablet by mouth 12 weeks




Primary Outcome Measures :
  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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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. [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Change in the number of EPCs after 12-week treatment [ Time Frame: 12 weeeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301806


Contacts
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Contact: Yoshimasa Aso, MD 81-282-86-1111 yaso@dokkyomed.ac.jp
Contact: Kunihiro Suzuki, MD 81-282-86-1111 kuni-s@dokkyomed.ac.jp

Locations
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Japan
Dokkyo Medical University Recruiting
Mibu, Tochigo, Japan, 321-0293
Contact: Yoshimasa Aso, MD    81-282-86-1111    yaso@dokkyomed.ac.jp   
Principal Investigator: Yoshimasa Aso, MD         
Recruiting
Mibu, Japan
Sponsors and Collaborators
Dokkyo Medical University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Yoshimasa Aso Dokkyo Medical University

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Responsible Party: Yoshimasa Aso, Professor of Medicine, Dokkyo Medical University
ClinicalTrials.gov Identifier: NCT02301806     History of Changes
Other Study ID Numbers: C-282-02
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors