Unique ID issued by UMIN | UMIN000015203 |
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Receipt number | R000017635 |
Scientific Title | Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension. |
Date of disclosure of the study information | 2014/09/18 |
Last modified on | 2016/09/19 15:21:06 |
Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.
Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.
Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.
Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
This study aimed to investigate change of brain natriuretic peptide(BNP), atrial natriuretic peptide(ANP) and change of blood pressure by ABPM in TDM2 with hypertension.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Change of serum ANP/BNP value comparing with baseline.
change of fat area in the abdominal cavity comparing with baseline
change of HbA1c comparing with baseline
change of autonomic nerve function (heart rate variability, QT interval on electrocardiogram)
change of fluctuation of blood pressure in day
physical measurement(weight, waist circumference)
echocardiogram
blood test (blood glucose, HbA1c, uric acid, insulin, 1.5AG, total ketone body, renin, aldosterone)
urinalysis (sodium, potassium, glucose, creatinine, uric acid)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
dapagliflozin
20 | years-old | <= |
75 | years-old | >= |
Male and Female
patients T2DM patients with hypertension
1)HbA1C higher than6.5% but lowre than 9%
2)BNP 30-200pg ml
3)acceptable for combination therapy with other anti hyperglycemic agents
4)Blood Pressure higher than 130 and or higher than 85mmHg
with anti hypertension agents
5)acceptable for therapy with lipid lowering drug and antihyperuricemic drug
6)20-75years
7)serum creatinine lower than 1.5mg dl
8)higher than BMI18.5
9)subjects who can measure by dualscan
10)subjects who give consent document about participation in the clinical study
1) Patients who are Type I or Secondary diabetic mellitus
2) Patients who are treating with Insulin theraphy at the time of study initiation
3) Patients who are severe infectious disease, perioperative, and severe trauma
4)Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant
5)Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction before 3 month
6) patients with Arrhythmia,atrial fibrillation
7) Patients with a history of hypersensitivity to investigational drugs
8) Patients with cancer
9) Patients who receive steroid therapy with inflammatory affection
10) Patients whom doctor judges as ineligible to this study
30
1st name | |
Middle name | |
Last name | Izuru Masuda |
Takeda Hospital
Medical Examination Center
3F, Nihonseimei Kyoto Santetsu Bldg 608 Higashi-Shiokoji-cho, Shimogyoku, Kyoto, Japan
075-365-0825
imasuda@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Izuru Masuda |
Takeda Hospital
Medical Examination Center
3F, Nihonseimei Kyoto Santetsu Bldg 608 Higashi-Shiokoji-cho, Shimogyoku, Kyoto,
075-365-0825
imasuda@kuhp.kyoto-u.ac.jp
Takeda Hospital Medical Examination Center
Japan Vascular Disease Research Foundation
Non profit foundation
Ijinkai Takeda Hospital
NO
2014 | Year | 09 | Month | 18 | Day |
Partially published
Preinitiation
2014 | Year | 09 | Month | 18 | Day |
2014 | Year | 09 | Month | 19 | Day |
2015 | Year | 02 | Month | 28 | Day |
2015 | Year | 06 | Month | 30 | Day |
2015 | Year | 11 | Month | 23 | Day |
2015 | Year | 12 | Month | 17 | Day |
2014 | Year | 09 | Month | 18 | Day |
2016 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017635
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