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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | sitagliptin 50 mg tablet by mouth 12 weeks |
|
| Glimepiride | Active Comparator | glimepiride 1 mg tablet by mouth 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dieting | Other |
| ||
| Sitagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of EPCs after 12-week treatment | 12 weeeks |
Inclusion Criteria:
Exclusion Criteria:
・Type I diabetes
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Yoshimasa Aso | Dokkyo Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokkyo Medical University | Recruiting | Mibu | Tochigo | 321-0293 | Japan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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sitagliptin 50 mg tablet by mouth 12 weeks |
|
| Glimepiride | Drug | glimepiride 1 mg tablet by mouth 12 weeks |
|
| Recruiting | Mibu | Japan |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |