Unique ID issued by UMIN | UMIN000013898 |
---|---|
Receipt number | R000016207 |
Scientific Title | Efficacy and safety of SGLT2 inhibitor, Ipragliflozin in type 2 diabetes patients. |
Date of disclosure of the study information | 2014/05/07 |
Last modified on | 2014/05/08 14:29:12 |
Efficacy and safety of SGLT2 inhibitor, Ipragliflozin in type 2 diabetes patients.
Efficacy and Safety of SGLT2 inhibitor Ipragliflozin in type 2 diabetes patients.(ESST2)
Efficacy and safety of SGLT2 inhibitor, Ipragliflozin in type 2 diabetes patients.
Efficacy and Safety of SGLT2 inhibitor Ipragliflozin in type 2 diabetes patients.(ESST2)
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
The aim of this study is to evaluate the efficacy and safety of Ipragliflozin, SGLT2 inhibitor which is a new oral hypoglycemic agent, by using continuous blood glucose monitoring under hospitalization in type 2 diabetes patients treated with diet and exercise therapy and/or oral hypoglycemic agent(metformin etc).
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
(1)glucose metabolism: at the baseline and the end of the study.
1)HbA1c,1,5-AG
2)Fasting plasma glucose, insulin, HOMA-R
3)Blood ketone body, free fatty acid, Adiponectin
(2)The change of body weight/Body Mass Index(BMI)/body fat ratio: measuring every day through study period.
(3)Continuous Glucose Monitoring (CGM system-Gold TM): at the baseline and the end of the study period, we measure the blood glucose profile for 72 hours before and after Ipragliflozin treatment.
(1)24 hours urine glucose amount and electrolyte (include Na, Ca) excretion in urine:measuring at the baseline and during trial period, we measure the amount of urine sugar/24 hours and quantity of urine electrolyte under hospitalization.
(2)Lipid metabolism: serum T-chol, HDL-C, LDL-C, TG, RLP-chol, LP(a), small dense LDL, MDA-LDL: measuring at the baseline and the end of the study period.
(3)Liver function, renal function, hematocrit level, amino acid analysis, lactic acid, pyruvic acid, BNP etc, measuring at the baseline and the end of the study period.
(4)The markers of tubular impairment (such as urinary beta2-MG, urinary NAG, urinary type IV collagen, L-FABP):
measuring at the baseline and the end of the study period.
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
SGLT-2 inhibitor(+)
20 | years-old | <= |
70 | years-old | > |
Male and Female
The outpatients with type 2 diabetes mellitus who are periodically visiting our hospital.
HbA1c(NGSP) level less than 10%,and type 2 diabetes patients who recieve diet and exercise therapy and/or taking oral hypoglycemic agents.
1.BMI >=22kg/m2and35kg/m2=<
2. age >=20
Male and Female
1.Patient who had myocardial infarction within the past six months.
2.Patient with a severe ketotic diabetic coma or precoma.
3.Patient with severe infectious disease (especially urinary tract infection), before and after operation, and a serious injury.
4.Patient with a past history of hypersensitivity for Ipragliflozin.
5.A pregnant woman or woman who may be pregnant.
6.Elderly person (>70 years).
7 Patient with hypoalimentation or dehydration.
8.Patient who is considered to be inappropriate by the chief physician.
During the entire study period,
when the chief physician judges that the continuing participation in this study became difficult, by aggravation such as HbA1c or blood glucose level and other factors, the appropriate treatment should be done immediately: administration of other antihyperglycemic agent or other appropriate measures.
15
1st name | |
Middle name | |
Last name | Eitaro Nakashima |
Chubu-Rosai Hospital
Department of Diabetes and Endocrinology
1-10-6,koumei,Minato-ku Nagoya, Aichi, JAPAN
+81-52-6525511
eitaro@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Minoru Kusama |
Chubu-Rosai Hospital
Department of Diabetes and Endocrinology
1-10-6,koumei,Minato-ku Nagoya, Aichi, JAPAN
+81-52-6525511
minyoru1101@yahoo.co.jp
Chubu-Rosai Hospital
Department of Diabetes and Endocrinology
Chubu-Rosai Hospital
Department of Diabetes and Endocrinology
Self funding
NO
労働者健康福祉機構 中部労災病院(愛知県)
2014 | Year | 05 | Month | 07 | Day |
Unpublished
Preinitiation
2014 | Year | 04 | Month | 24 | Day |
2014 | Year | 05 | Month | 11 | Day |
2014 | Year | 05 | Month | 07 | Day |
2014 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016207
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