Type 2 diabetes mellitus
Conditions
Interventions
Orally administration of 5mg Dapagliflozin once a day for 24weeks.
Sponsors
Tokai University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects appropriately diagnosed as type 2 DM by the latest report of the expert committee on the diagnosis and classification of diabetes mellitus 2. Patients who does not use other anti DM drugs within 8 weeks before consenting 3. Patients who have been treated with diet and exercise therapy 4. ALT >= 30IU/L or Fatty liver measured by ultra sonography 5. BMI >= 25kg/m2 6. Patients who can give their consent in a written form
Exclusion criteria
Exclusion criteria: 1. Patient who have alcohol intake more than 210g/week ethanol for males or 140g/week ethanol for females. 2. Patients diagnosed viral hepatitis, autoimmune hepatitis, primary biliary cholangitis, drug-induced liver disease, biliary disorder, shock liver, hemochromatosis, Wilson's disease, and alpha1-antitrypsin deficiency 3. Patients diagnosed hepatic cirrhosis 4. Patients with a history of diabetic ketoacidosis 5. Type 1 diabetes mellitus or secondary diabetes 6. Serious renal dysfunction (serum Cre 1.3mg/dl or eGFR<45ml/min/1.73m2) 7. Pregnancy or possible pregnancy and breast feeding 8. Patients who had cerebral stroke, cerebral infarction, urinary infection, or genital infection within 12 weeks before giving their consent 9. Patients who had myocardial infarction, angina pectoris or atrial fibrillation 10. Patient with inability to take the drug by mouse 11. History of hypersensitivity to any of the ingredients of the study drug 12. Patient with contraindications to the study drug 13. In addition, when principal investigator or researcher deems inappropriate as a study subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the change of hepatic lipid content measured by MRS at 24 weeks after starting trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the change of blood and urine examination at 4,12, and 24 weeks after starting trial. Evaluation of the change of microbiota at 24 weeks after starting trial. Evaluation of the change of body composition measured by InBody at 12 and 24 weeks after starting trial. Evaluation of the change of CAP and LSM measured by Fibroscan at 12 and 24 weeks after starting trial. | — |
Countries
Japan
Contacts
Public ContactKota Tsuruya
Tokai University School of Medicine Department of Gastroenterology
Outcome results
None listed