Unique ID issued by UMIN | UMIN000014422 |
---|---|
Receipt number | R000016779 |
Scientific Title | Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors |
Date of disclosure of the study information | 2014/06/30 |
Last modified on | 2015/07/01 16:21:27 |
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
Comparison between the non-administration group and the administration group of SGLT2 inhibitor
1) Change of s-dense-LDL (sd-LDL), IDL, LDL, VLDL and HDL
2) Change of body weight, blood pressure
3) Change of HOMA-beta, HOMA-IR, hsCRP
4) Change of serum creatinine, cystatin C and urinary albumin
5) Change of HbA1c and GA
6) To evaluate the change of dietary lifestyle (based on dietary habits questionnaire)
7) To evaluate the safety such as dehydration, urinary tract infection and genital infection
Safety,Efficacy
1) Improving effects of sd-LDL, IDL, LDL and HDL using by Lipofo-AS
2) TC, TG, HDL-C, LDL-C, LDL/HDL-C rate and non HDL-C
1) Lowering effects of body weight and blood pressure
2) Improving effects of hsCRP, HOMA-beta and HOMA-R
3) Lowering effects of HbA1c and GA
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
NO
2
Treatment
Medicine |
Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 12 weeks
Ipragliflozin non-administrated group (Continuation of conventional therapy)
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Aged from 20 to less than 65 years at providing consent
2) Type 2 diabetes patients with BMI >= 24 kg/m2
3) HbA1c (NGSP) was from 7% to less than 10% for 3 months or more, under conventional thrapy (HbA1c >= 7.5% in case of having sulfonylureas and glinides)
1) With receiving insulin therapy
2) With a history of ischemic heart disease (angina pectoris, myocardial infarction) and ischemic stroke
3) Serum Creatinine >= 1.2 mg/dL
4) Fasting serum triglycerides levels >= 400 mg/dL
5) HbA1c was changed 2% or more within 3 months
6) With unconscious thirst (impossible self-judgement water intake)
7) With contraindication for ipragliflozin
a) History of hypersensitivity to ipragliflozin
b) Severe ketosis, diabetic or precoma
c) Severe infection, pre or post surgery, and severe trauma
8) Considered as inadequate by the investigator
100
1st name | |
Middle name | |
Last name | Yukihiro Bando |
Fukui-ken Saiseikai Hospital
internal
Funabashi 7-1, Wadanaka-cho, Fukui-city, Fukui, Japan
0776-23-1111
Y-BANDO@fukui.saiseikai.or.jp
1st name | |
Middle name | |
Last name | Yukihiro Bando |
Fukui-ken Saiseikai Hospital
internal
Funabashi 7-1, Wadanaka-cho, Fukui-city, Fukui, Japan
0776-23-1111
Y-BANDO@fukui.saiseikai.or.jp
Fukui-ken Saiseikai Hospital
Astellas Pharma Inc.
Profit organization
NO
2014 | Year | 06 | Month | 30 | Day |
Unpublished
Completed
2014 | Year | 06 | Month | 18 | Day |
2014 | Year | 07 | Month | 01 | Day |
2014 | Year | 06 | Month | 30 | Day |
2015 | Year | 07 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016779