Unique ID issued by UMIN | UMIN000018265 |
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Receipt number | R000021137 |
Scientific Title | Direct comparison of TOfogliflozin and iPragliflozin on hyper-hypoglycemia using Continuous Glucose Monitoring system (TOP-CGM) |
Date of disclosure of the study information | 2015/07/10 |
Last modified on | 2016/09/12 11:23:33 |
Direct comparison of TOfogliflozin and iPragliflozin
on hyper-hypoglycemia using Continuous Glucose Monitoring system (TOP-CGM)
Tofogliflozin and continuous glucose monitoring
Direct comparison of TOfogliflozin and iPragliflozin
on hyper-hypoglycemia using Continuous Glucose Monitoring system (TOP-CGM)
Tofogliflozin and continuous glucose monitoring
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To compare SGLT2 inhibitors, tofogliflozin and ipragliflozin on hyper-hypoglycemia using continuous glucose monitoring system -randomized cross-over study-
Efficacy
Time under 70mg/dl using continuous glucose monitoring system
(1) CGMS measurements
(2) Changes in the variables listed below.
1-Fasting plasma glucose and HbA1c(NGSP value)
2-serum creatinine, BUN, Na, K, ,Cl, Mg, Ca, P, uric acid,ketone bodies(total ketone body, Acetoacetic acid and beta-hydroxybutyrate), glycemic related hormones(proinsulin, insulin, c-peptide, glucagon, free fatty acid)
3-urinanalysis(Na, K, Cl, Ca, creatinine, urine volume, urine glucose)
4- Reactive hyperemia index (RHI)
(3) Meal tolerance test measurements
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Tofogliflozin and wash out and Ipragliflozin
Ipragliflozin and wash out and Tofogliflozin
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1)Diagnosed as Type 2 diabetes
(2)20=<informed conscent age<65
(3)22.0=<BMI<45
(4)Registration inspection before 4 weeks or more, patients are administered without prescription change in the regimen of diet and exercise therapy and SU
(5) With estimated glomerular function >= 45 ml/min/1.73m2
(6)Subjects who give consent document about participation in the clinical study
(1) Has hypersensitivity to tofogliflozin and ipragliflozin or any other excipient of them
(2) With severe ketosis, diabetic coma, or precoma
(3) With severe infection, pre or post-surgery, and serious trauma
(4)Has arteriosclerotic disease (myocardial infarction, stroke and so on) and history of them
(5) End-stage renal disease (ESRD) undergoing hemodialysis
(6) With severe liver dysfunction
(7) Has insulin therapy
(8) Entered already with another clinical trials
(9) Considered as inadequate by the investigator
30
1st name | |
Middle name | |
Last name | Yosuke Okada |
University of Occupational and Environmental Health
First Department of Internal Medicine, School of Medicine
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
+8100936031611
y-okada@med.uoeh-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroko Mori |
University of Occupational and Environmental Health
First Department of Internal Medicine, School of Medicine
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
+8100936031611
morihiro@med.uoeh-u.ac.jp
University of Occupational and Environmental Health
KOWA COMPANY,LTD
Profit organization
NO
2015 | Year | 07 | Month | 10 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 05 | Month | 01 | Day |
2015 | Year | 07 | Month | 13 | Day |
2015 | Year | 07 | Month | 10 | Day |
2016 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021137
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