Unique ID issued by UMIN | UMIN000016635 |
---|---|
Receipt number | R000019290 |
Scientific Title | Study on glycemic control, weight, body fat and insulin resistance in SGLT2 inhibitor-treated Japanese patients |
Date of disclosure of the study information | 2015/03/01 |
Last modified on | 2020/01/10 14:34:18 |
Study on glycemic control, weight, body fat and insulin resistance in SGLT2 inhibitor-treated Japanese patients
SGLT2 Study
Study on glycemic control, weight, body fat and insulin resistance in SGLT2 inhibitor-treated Japanese patients
SGLT2 Study
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To confirm and describe the main factors of weight loss even in Japanese is the reduction of body fat
To weigh and describe the correlations between each items such as body weight, abdominal circumference, body fat, HbA1c, visceral fat, blood pressure, adiponectin, and insulin resistance
Efficacy
Exploratory
Pragmatic
Not applicable
HbA1c ,FPG ,Body weight ,Body mass index ,Body fat
Visceral fat area ,Waist circumference ,Amount of body fat distribution ,Lean body weight ,HOMA-IR ,HOMA-b ,iHOMA2 ,Blood pressure ,Lipid ,Uric acid ,eGFR ,GIR ,Liver function ,Renal function ,Adiponectin ,TNFa ,IL-6 ,NTpro-BNP
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Take CANAGLU Tablets 100mg at the oral.
1tablet/day
Period of 24 weeks
Conducted blood sampling and body fat,abdominalCT ,etc. before and after intervention.
Not applicable |
70 | years-old | >= |
Male and Female
Informed consent obtained in writing before any trial-related activities.
Type 2 Diabetes
Age <= 70 years old
HbA1c between 7.0% and 10.0%
BMI >= 23 kg/m2
Creatinine < 1.0mg/dL for male
< 0.8mg/dL for female
Extreme low carbohydrate therapy practitioner.
Considered as inappropriate by the attending physician.
A person who falls under contraindication in the medical package insert.
30
1st name | Shin-ichiro |
Middle name | |
Last name | Shirabe |
Medical Corporation
H.E.C Science Clinic
Diabetes medicine
235-0045
4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
045-831-0031
hec-soum@asahi-net.email.ne.jp
1st name | Takashi |
Middle name | |
Last name | Makuuchi |
Medical Corporation H.E.C Science Clinic
Clinical Trial Secretariat
235-0045
4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
045-831-0031
hec-soum@asahi-net.email.ne.jp
Medical Corporation
H.E.C Science Clinic
Mitsubishi Tanabe Pharma Corporation
Profit organization
Ethics review committee of Medical Corporation H.E.C Science Clinic
4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
045-831-0031
hec-soum@asahi-net.email.ne.jp
NO
医療法人社団一洋会 H.E.Cサイエンスクリニック(神奈川県)
2015 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 08 | Month | 06 | Day |
2014 | Year | 08 | Month | 06 | Day |
2014 | Year | 10 | Month | 01 | Day |
2015 | Year | 10 | Month | 31 | Day |
2015 | Year | 11 | Month | 30 | Day |
2015 | Year | 11 | Month | 30 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 02 | Month | 25 | Day |
2020 | Year | 01 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019290
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