Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
dieting
Sitagliptin
Glimepiride
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
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
Sites / Locations
- Dokkyo Medical UniversityRecruiting
- Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sitagliptin
Glimepiride
Arm Description
sitagliptin 50 mg tablet by mouth 12 weeks
glimepiride 1 mg tablet by mouth 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02301806
First Posted
November 22, 2014
Last Updated
February 15, 2016
Sponsor
Dokkyo Medical University
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02301806
Brief Title
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
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokkyo Medical University
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
sitagliptin 50 mg tablet by mouth 12 weeks
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
glimepiride 1 mg tablet by mouth 12 weeks
Intervention Type
Other
Intervention Name(s)
dieting
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
sitagliptin 50 mg tablet by mouth 12 weeks
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Intervention Description
glimepiride 1 mg tablet by mouth 12 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Change in the number of EPCs after 12-week treatment
Time Frame
12 weeeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoshimasa Aso, MD
Phone
81-282-86-1111
Email
yaso@dokkyomed.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Kunihiro Suzuki, MD
Phone
81-282-86-1111
Email
kuni-s@dokkyomed.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshimasa Aso
Organizational Affiliation
Dokkyo Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokkyo Medical University
City
Mibu
State/Province
Tochigo
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshimasa Aso, MD
Phone
81-282-86-1111
Email
yaso@dokkyomed.ac.jp
First Name & Middle Initial & Last Name & Degree
Yoshimasa Aso, MD
City
Mibu
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
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