Unique ID issued by UMIN | UMIN000014129 |
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Receipt number | R000016419 |
Scientific Title | Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus |
Date of disclosure of the study information | 2014/05/31 |
Last modified on | 2023/03/28 17:52:56 |
Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus
AYUMI
Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus
AYUMI
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To investigate the safety and efficacy of tofogliflozin under usual care
Safety,Efficacy
The following side effects:events, grades, occurrence rates, etc
*Hypoglycemia
*Urinary tract infection and Genital infection
*Volume depletion (Dehydration, Polyuria/Pollakiuria, Hypotension)
*Diabetic ketoacidosis
*Renal dysfunction
*Hepatic dysfunction
*Fracture
*Malignant tumor
*Major adverse cerebro-cardiovascular events
*Skin disorders
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1.Patients with Type 2 diabetes mellitus
2.Receiving tofogliflozin under usual care within 8 weeks before registration
3.Aged 20 and over
4.No use of SGLT2 inhibitor before tofogliflozin
1.Hypersensitivity to tofogliflozin
2.Patients who had severe ketosis or diabetic coma or precoma
3.Severe infection or trauma, perioperative
4.End stage renal disease with hemodialysis or peritoneal dialysis
5.Patients whose participation is deemed inappropriate at the discretion of the attending physician
10000
1st name | Yuichiro |
Middle name | |
Last name | Yamada |
Japan Association for Diabetes Education and Care
Academic committee
102-0083
2-2-4 Kojimachi, Chiyoda-Ku, Tokyo, 102-0083 Japan
03-3514-1721
yamada.yuuichiro@a3.kepco.co.jp
1st name | Nobuyuki |
Middle name | |
Last name | Shihara |
Japan Association for Diabetes Education and Care
secretariat
102-0083
2-2-4 Kojimachi, Chiyoda-Ku, Tokyo, 102-0083 Japan
03-3514-1721
http://www.nittokyo.or.jp/about/research/report/detail.php?t=1&p=13
shihara@nittokyo.or.jp
Japan Association for Diabetes Education and Care
Kowa Company, Ltd.
Kowa Pharmaceutical Co. Ltd.
Profit organization
Ethic committee of Japan Association for Diabetes Education and Care
2-2-4 Kojimachi,Chiyoda-ku,Tokyo
03-3514-1721
rinri@nittokyo.or.jp
NO
2014 | Year | 05 | Month | 31 | Day |
Unpublished
No longer recruiting
2014 | Year | 04 | Month | 25 | Day |
2013 | Year | 12 | Month | 27 | Day |
2014 | Year | 06 | Month | 01 | Day |
2018 | Year | 02 | Month | 28 | Day |
A survey of commercially available drugs performed by physicians on a voluntary basis
2014 | Year | 05 | Month | 31 | Day |
2023 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016419
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