Unique ID issued by UMIN | UMIN000008358 |
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Receipt number | R000009810 |
Scientific Title | Vildagliptin versus Standard Therapy on Coronary flow reserve in Type2 Diabetes Mellitus-Juntendo |
Date of disclosure of the study information | 2012/07/10 |
Last modified on | 2015/07/05 12:52:51 |
Vildagliptin versus Standard Therapy on Coronary flow reserve in Type2 Diabetes Mellitus-Juntendo
VIVALDI study
Vildagliptin versus Standard Therapy on Coronary flow reserve in Type2 Diabetes Mellitus-Juntendo
VIVALDI study
Japan |
Type 2 Diabetes Mellitus
Medicine in general | Cardiology | Endocrinology and Metabolism |
Others
NO
The aim is to investigate the differences of coronary flow reserve between the patinets with Vildagliptin and those with standard therapy on type2 diabetes mellitus.
Safety,Efficacy
The change of coronary flow reserve assessed by echocardiography
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
The therapy using Vildagliptin on type2 diabetes mellitus
Standard therapy on type2 diabetes mellitus
20 | years-old | <= |
Not applicable |
Male and Female
1)Inadequate glucose control even after dietary and exercise therapies amd standard therapy
2)Patients don't have coronary stenosis at left anterior descending artery with angiographically detected
Exclusion criteria
1) Patients with coronary stenosis at left anterior descending artery
2) Allergy for dipeptidyl-peptidase4 inhibitor and sulfonylureas
3) Ongoing treatment with a DPP-4 inhibitor, GLP-1 analog and insulin
4) Patients with diabetic ketoacidosis or diabetic coma or type 1 diabetes
5) Patients who underwent 2 or over stents implantation for left anterior descending artery
6) Severe liver dysfunction
7) Patients with moderate or severe renal disorder (creatinine level: 1.5 mg/dL [men] or 1.3 mg/dL [women]).
8) Old anterior wall myocardial infarction
9) Pregnant or nursing woman
10)Other patients judged as being inappropriate for the subjects of the study by investigators.
40
1st name | |
Middle name | |
Last name | Masao Daimon |
Juntendo University
Department of Cardiology
2-1-1 Hongou Bunkyo-ku Tokyo Japan
03-3813-3111
masaodaimon@gmail.com
1st name | |
Middle name | |
Last name | Masaki Maruyama |
Juntendo University
Department of Cardiology
2-1-1 Hongou Bunkyo-ku Tokyo Japan
03-5802-1056
marumasa@juntendo.ac.jp
Juntendo University School of Medicine
Juntendo University School of Medicine
Self funding
NO
順天堂大学医学部附属順天堂医院(東京都)
2012 | Year | 07 | Month | 10 | Day |
Unpublished
Completed
2012 | Year | 07 | Month | 04 | Day |
2012 | Year | 07 | Month | 01 | Day |
2012 | Year | 07 | Month | 05 | Day |
2015 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009810
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