Unique ID issued by UMIN | UMIN000027337 |
---|---|
Receipt number | R000031322 |
Scientific Title | Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study |
Date of disclosure of the study information | 2017/05/14 |
Last modified on | 2017/11/14 09:48:29 |
Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study
Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study
Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study
Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study
Japan |
Type 2 diabetes with nonalcoholic fatty liver disease
Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Others
NO
Comparison of therapeutic effect on NAFLD using SGLT2 inhibitor, bezafibrate or conventional therapeutic agent
Efficacy
Change from baseline in liver-to-spleen attenuation ratio (L/S ratio) by CT at week 60
Changes from baseline in AST, ALT, HbA1c, fasting plasma glucose, bodyweight, abdominal visceral adipose tissue, and subcutaneous adipose tissue, Hypoglycemia by using CGM, electrocardiogram change by using Holter electrocardiogram
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
4
Treatment
Medicine |
SGLT2 inhibitor for 60 weeks
Bezafibrate 200~400mg for 60 weeks
SGLT2 inhibitor/Bezafibrate 200-400mg combined group for 60 weeks
Conventional treatment group for 60 weeks
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. Patients with type 2 diabetes
2. Patients(20 years or over and under 70 years old ) who are able to provide written informed consent.
3.HbA1c higher than 6.0 and lower than 10%
1.type 1 diabetic patients
2.patients who are being treated for liver disease other than NAFLD
3.Male:serum creatinine higher than 1.2mg/dL Femake:serum creatinine higher than 1.0mg/dL patients
4.Patients who can not be aware of dry mouth
5.SGLT2 inhibitor/Bezafibrate contraindication case
6.Patients with a history of hypersensitivity to SGLT2 inhibitor/Bezafibrate
7.Patients judged to be ineligible by a doctor
80
1st name | |
Middle name | |
Last name | Ikuo Inoue |
Saitama Medical University Hospital
Department of Endocrinology and Diabetes
38 Morohongo, Moroyamacho, Irumagun, Saitama 350-0495, Japan
049-276-1204
i1901018@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Daigo Saito |
Saitama Medical University Hospital
Department of Endocrinology and Diabetes
38 Morohongo, Moroyamacho, Irumagun, Saitama 350-0495, Japan
049-276-1204
daigo622@saitama-med.ac.jp
Saitama Medical University Hospital
None
Self funding
NO
2017 | Year | 05 | Month | 14 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 05 | Month | 12 | Day |
2017 | Year | 06 | Month | 01 | Day |
2017 | Year | 05 | Month | 14 | Day |
2017 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031322