Unique ID issued by UMIN | UMIN000025852 |
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Receipt number | R000029676 |
Scientific Title | Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes |
Date of disclosure of the study information | 2017/01/26 |
Last modified on | 2019/04/05 18:41:18 |
Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Japan |
Type2 diabetes Mellitus
Medicine in general |
Others
NO
SGLT2 inhibitors have not only lower glucose but weight loss and lower blood pressure. These effect lead to preventing cardio vascular disease caused by diabetes. In this study, we compare about the effect for the risk of CVD by using CAVI, between Luseogliflozin, is one of the SGLT2 inhibitors, and amaryl, has showed improving the deta of CAVI.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
We evaluate the variations of HbA1c and CAVI from the begining of treatment to week 24.
We evaluate the variations of the following items from the begining of treatment to week 24.
Hight,body weight,girth of the abdomen,blood pressure,inbody,ABI,fasting plasma glucose,IRI,TC,TG,LDL-C,HDL-C,LPLmass,d-ROMs,keton body,urinalysis(general,glucose and albumin)
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
SGLT2 inhibitor(Luseogliflozin)
Amaryl(glimepiride)
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)Type2 diabetic patients
2)Patients whose BMI is over 25 and HbA1c is over 7.0% but under 8.5%
3)Patients using Biguanide, DPP4 inhibitor and/or GLP1 analog(it doesn't matter any dose)
1)Type1 diabetic patients or IDDM
2)Patients using insulin
3)Patients had cardiovascular disease or cerebrovascular disease in the past
4)Patients who are judged to be inadequate to use SGLT2 inhibitor
5)Patients with severe infections, patients before or after operations orhaving seriousexternal injuries
6)Patients with allergy to the ingredient(s) of these medicines(Luseogliflozin or amaryl)
7)Patients with severe renal dysfunction or end-stage renal disease undergoing artificial dialysis
8)Patients with severe liver dysfunction
9)Patients with
10)Pregnant women or lactating women
11)Patients who are judged to be inadequate to participate in this study by a doctor in charge
40
1st name | |
Middle name | |
Last name | Ichiro Tatsuno |
Toho University Sakura Medical Center.
Center of Diabetes, Endocrinology and Metabolism
564-1,Shimoshizu,Sakura-city,Chiba
043-462-8811
ichiro.tatsuno@med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Ichiro Tatsuno |
Toho University Sakura Medical Center.
Center of Diabetes, Endocrinology and Metabolism
564-1,Shimoshizu,Sakura-city,Chiba
043-462-8811
ichiro.tatsuno@med.toho-u.ac.jp
Toho University Sakura Medical Center.
Taisho Toyama Pharmaceutical Co. ,Ltd.
Profit organization
NO
2017 | Year | 01 | Month | 26 | Day |
Unpublished
Completed
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 08 | Month | 12 | Day |
2017 | Year | 01 | Month | 01 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 01 | Month | 26 | Day |
2019 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029676
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