Type 2 diabetes mellitus with hepatic steatosis
Conditions
Interventions
Switching from DPP4 inhibitor/other drug to or adding Luseogliflozin versus switching from other drugs to DPP4 inhibitor or continuing of DPP4 inhibitor
Arm 1: SGLT2 inhibitor (Luseogliflozin)
Arm 2:
Sponsors
Tsuchiya Kyoichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes mellitus 2) Hepatic steatosis 3) Outpatients or inpatients 4) Meeting the following criteria with the tests results =6.5% and =250db/m 5) Aged >=20 years, =<75 years at consent 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) SGLT2 inhibitor taken within 1 year before consent 2) Pioglitazone taken within 1 year before consent 3) Viral hepatitis 4) Severe ketosis, diabetic coma or precoma 5) Severe infection, pre and post surgery, and severe injury 6) History of hypersensitivity to any of the ingredients of the study drug 7) Servere hepatic dysfunction 8) Severe renal dysfunction or patients requiring dialysis (including peritoneal dialysis) 9) Dehydration or pre-clinical dehydration 10) malnutrition, famine, debilitation, pituitary (gland) malfunction or adrenal gland dysfunction 11) Severe impairment of cardiovascular or lung function (such as shock, heart failure, cardiac infarct, pulmonary embolism) or patient tend to be hypoxia 12) Excessive alcohol intake 13) Diabetic ketoacidosis 14) History of lactic acidosis 15) Pregnant 16) Nursing 17) Female patient who is unable to take abstinence or effective contraceptive methods during this study 18) Contraindication to MRI 19) Judged ineligible by doctor in charge for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in proton density fat fraction (PDFF) as measured by MRI from baseline* to 24 weeks after the intervention Comparison of Arm 1 and Arm 2 *before the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in liver stiffness as measured by MRI from baseline to 24 weeks after the intervention Comparison of Arm 1 and Arm 2 using t-test 2) Change in liver stiffness as measured by Fibroscan and CAP from baseline to 12 and 24 weeks after the intervention Comparison of Arm 1 and Arm 2 using t-test 3) Change in the following serum markers from baseline to 4, 12 and 24 weeks after the intervention; gamma-GTP, AST, ALT, TG, LDL-Chol, HDL- Chol, HbA1c, M2BPGI, Type 4 collagen7S, HMGB1 Comparison of Arm 1 and Arm 2 using t-test 4) Change in body weight and body fat percentage from baseline to 24 weeks after the intervention Comparison of Arm 1 and Arm 2 using t-test | — |
Contacts
Public ContactKyoichiro Tsuchiya
University of Yamanashi Hospital
Outcome results
None listed