Unique ID issued by UMIN | UMIN000015402 |
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Receipt number | R000017913 |
Scientific Title | Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes |
Date of disclosure of the study information | 2014/11/01 |
Last modified on | 2014/10/10 12:57:37 |
Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To collectively evaluate the effects of a SGLT2 inhibitor on patients assessing glucose metabolism, body weight, food consumption and composition, physical activity, body composition over time.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
HbA1c, fasting plasma glucose, insulin, body weight, fat mass, lean body mass, food consumption
serum osmolality, urine osmolality, blood urea nitrogen, serum creatinine, LDL cholesterol, HDL cholesterol, triglyceride, free fatty acid, GOT, GPT, glucagon, GLP-1
Observational
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1.Patients with type 2 diabetes mellitus
2.HbA1c 7.0-10.0%
3.Patients who have received anti-diabetics without any change over at least 3 months
4.The change in body weight is 2 kg or less and that of HbA1c is 0.5% or less over at least 3 months
5.Patients who provided written informed consent
1.Serious infection
2.Serious liver and/or kidney disease
3.End stage renal disease with undergoing hemodialysis or peritoneal dialysis
30
1st name | |
Middle name | |
Last name | Toshio Iwakura |
Kobe City Medical Center General Hospital
Department of Diabetes and Endocrinology
1-1-2, Minatojimaminamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan
078-302-4321
iwakura@kcho.jp
1st name | |
Middle name | |
Last name | Toshio Iwakura |
Kobe City Medical Center General Hospital
Department of Diabetes and Endocrinology
1-1-2, Minatojimaminamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan
078-302-4321
iwakura@kcho.jp
Department of Diabetes and Endocrinology
Kobe City Medical Center General Hospital
Department of Diabetes and Endocrinology
Kobe City Medical Center General Hospital
Other
NO
神戸市立医療センター中央市民病院
2014 | Year | 11 | Month | 01 | Day |
Unpublished
Preinitiation
2014 | Year | 09 | Month | 16 | Day |
2014 | Year | 11 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
2015 | Year | 10 | Month | 31 | Day |
2015 | Year | 10 | Month | 31 | Day |
2015 | Year | 12 | Month | 01 | Day |
prospective study
2014 | Year | 10 | Month | 10 | Day |
2014 | Year | 10 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017913
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