Unique ID issued by UMIN | UMIN000015369 |
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Receipt number | R000017886 |
Scientific Title | The study of dapagliflozin (sodium glucose cotransporter 2 inhibitor) to verify the efficacy of combination therapy in Japanese patients with type 2 diabetes |
Date of disclosure of the study information | 2014/10/08 |
Last modified on | 2017/04/10 20:15:47 |
The study of dapagliflozin (sodium glucose cotransporter 2 inhibitor) to verify the efficacy of combination therapy in Japanese patients with type 2 diabetes
DISCOVERY study
The study of dapagliflozin (sodium glucose cotransporter 2 inhibitor) to verify the efficacy of combination therapy in Japanese patients with type 2 diabetes
DISCOVERY study
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To investigate the efficacy and the safety of SGLT2 inhibitor, dapaglifrozin, in patients with type 2 diabetes
Safety,Efficacy
Change and percent change in HbA1c from baseline to 6 months
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Orally administration of 5 mg dapagliflozin once a day for 6 months
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Age: >= 20 and <= 75
2) HbA1c: >= 7.0 and <= 10%
3) Change of HbA1c within 3 months prior to registration: <= +/-1%
1) type 1 diabetes
2) BMI: >= 45
3) patients suspected of pregnancy or pregnant or nursing
4) diabetes insipidus
5) severe liver dysfunction (liver cirrhosis, viral hepatitis, AST: >= 3 times of upper limit)
6) moderate renal dysfunction (eGFR: < 45 ml/min/1.73m2)
7) heart disease (myocardial infarction, unstable angina) or stroke within 3 months
8) considered as inadequate by the investigator
100
1st name | |
Middle name | |
Last name | JUN WADA |
Okayama University Hospital
nephrology, diabates and endocrinology
2-5-1 Shikata-cho, Kita-ku, Okayama
086-235-7235
junwada@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | DAISUKE OGAWA |
Okayama University Hospital
nephrology, diabates and endocrinology
2-5-1 Shikata-cho, Kita-ku, Okayama
086-235-7235
daiogawa@md.okayama-u.ac.jp
Okayama University Hospital
nephrology, diabates and endocrinology
none
Self funding
NO
2014 | Year | 10 | Month | 08 | Day |
Unpublished
Completed
2014 | Year | 05 | Month | 27 | Day |
2014 | Year | 06 | Month | 24 | Day |
2014 | Year | 10 | Month | 08 | Day |
2017 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017886
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