Unique ID issued by UMIN | UMIN000004955 |
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Receipt number | R000005897 |
Scientific Title | Comparison of the effect on vascular endothelial function and systemic metabolism in type 2 diabetic patients between sitagliptin and glimepiride -prospective randomized controlled trial- |
Date of disclosure of the study information | 2011/01/31 |
Last modified on | 2016/09/27 16:17:18 |
Comparison of the effect on vascular endothelial function and systemic metabolism in type 2 diabetic patients between sitagliptin and glimepiride
-prospective randomized controlled trial-
Study for the effects of sitagliptin on vascular endothelial function and systemic metabolism in type 2 diabetic patients
Comparison of the effect on vascular endothelial function and systemic metabolism in type 2 diabetic patients between sitagliptin and glimepiride
-prospective randomized controlled trial-
Study for the effects of sitagliptin on vascular endothelial function and systemic metabolism in type 2 diabetic patients
Japan |
type 2 diabetes mellitus
Medicine in general | Cardiology | Endocrinology and Metabolism |
Others
NO
To compare the effects on arteriosclerosis in type 2 diabetic patients between sitagliptin and glimepiride
Efficacy
Exploratory
Explanatory
Phase IV
Change in FMD(Flow mediated dilatation)
1) glucose and lipid metabolism, 2) beta cell function, 3) changes in TBI(Toe-brachial index) and Task force monitor, 4) several biomarkers (adipokines, oxidative stress, etc)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
sitagliptin
glimepiride
20 | years-old | <= |
Not applicable |
Male and Female
1) Type 2 diabetic patients treating with therapeutic diet and exercise, or with biguanide, 2) HbA1c 6.9-8.4%, 3) blood pressure and lipids are well controlled, 4) written informed consent
1) patients who received insulin injection therapy, 2) severe hepatic dysfunction, renal dysfunction, heart failure, 3) history of angina, myocardial infarction, stroke or other arteriosclerotic diseases, 4) patients who receive more than three antihypertensive agents, 5) patients who receive more than two antidyslipidemia agents, 6) history of anaphylaxis of sitagliptin or glimepiride, 7) pregnancy, 8) patients who are inadequate to enter this study due to the other reasons by physician's judgments
110
1st name | |
Middle name | |
Last name | Hideaki Miyoshi |
Hokkaido University Hospital
Department of Internal Medicine II
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
011-706-5915
hmiyoshi@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Hideaki Miyoshi |
Hokkaido University Hospital
Department of Internal Medicine II
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
011-706-5915
hmiyoshi@med.hokudai.ac.jp
Hokkaido University Hospital
The Waksman Foundation of Japan inc.
Non profit foundation
Japan
NO
北海道大学病院(北海道)、青木内科クリニック(北海道)、大塚眼科(北海道)、大通り内科クリニック(北海道)、岡本内科クリニック(北海道)、小野百合内科クリニック(北海道)、クラーク病院(北海道)、栗原内科(北海道)、国立病院機構北海道医療センター(北海道)、佐々木内科(北海道)、札幌社会保険総合病院(北海道)、市立札幌病院(北海道)、斗南病院(北海道)、北海道社会保険病院(北海道)、北海道中央労災病院せき損センター(北海道)、北陵内科(北海道)、萬田記念病院(北海道)、NTT東日本札幌病院(北海道)、時計台病院(北海道)
2011 | Year | 01 | Month | 31 | Day |
Published
Completed
2011 | Year | 01 | Month | 14 | Day |
2011 | Year | 01 | Month | 01 | Day |
2014 | Year | 03 | Month | 31 | Day |
2011 | Year | 01 | Month | 25 | Day |
2016 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005897
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