fatty liver with type 2 diabetes mellitus
Conditions
Interventions
Oral administration of 2.5mg luseogliflozin once a day for 24 weeks
Dietetic and exercise therapy
Sponsors
Fujita Health University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed concent 2. Aged >=20, <75 at consent 3. Type 2 diabetes mellitus 4. Diagnosed NAFLD by imaging test 5. AST>=33 or ALT>=30 in males, ALT>=27 in females
Exclusion criteria
Exclusion criteria: 1. Using insulin 2. Has hypersensitivity to luseogliflozin 3. Has history of hepatitis B, hepatitis C and autoimmune hepatitis 4. Excess alcohol consumption: 30g/day for males, 20g/day for females 5. Type 1 diabetes mellitus 6. HbA1c>9% 7. Has severe complication of diabetes 8. BMI<20 9. eGFR<45mL/min/1.73m2 10. Dialysis 11. Severe hepatic dysfunction and cirrhosis 12. Females who have a possibility of pregnancy or is pregnant 13. Has malignant neoplasm 14. After surgery and severe trauma 15. History of myocardinal infarction and angina pectoris 16. Had cerebral stroke, cerebral infanction, urinary infection or genital infection within 12 weeks before giving their consent 17. Using steroid and imunosuppressant 18. Using glimepiride>2mg/day, glibenclamide>1.25mg/day, gliclazide>40mg/day 19. Started other diabetic medicines or changed dose within 8 weeks before giving their consent 20. Using GLP-1 receptor agonist or SGLT2 inhibitors 21. In addition, when principal inverstigator or reseacher deems inappriate as a study subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT | — |
Countries
Japan
Contacts
Public ContactNaoto Kawabe
Fujita Health University Department of Gastroenterology and Hepatology
Outcome results
None listed