Type 2 diabetes,dyslipidemia,MAFLD
Conditions
Interventions
The principal investigator or research associate obtains written consent to participate in the study and determines eligibility by confirming that subjects meet the selection criteria and do not viola
Type 2 diabetes,dyslipidemia,MAFLD
Sponsors
Waki Hironori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women over 18 years old 2) Patients diagnosed with type 2 diabetes 3) Patients with HbA1c of 6.0-9.0% at screening (within 12 weeks of enrollment) 4) Patients diagnosed with dyslipidemia (hyperlipidemia) 5) Patients with ALT between 31 IU/L and 100 IU/L at screening (within 12 weeks of enrollment) 6) Patients with fatty liver on previous imaging such as ultrasonography and CT 7) Written consent has been obtained prior to the study
Exclusion criteria
Exclusion criteria: 1) Patients deemed by the physician to be inappropriate for study participation (e.g., excessive alcohol consumption, uncontrolled malignancy) 2) Patients with contraindications to pemafibrate 3) Patients with contraindications to tofogliflozin 4) Patients receiving other SGLT2 inhibitors or PPAR-alpha agonists within 6 months of enrollment 5) Patients with viral hepatitis 6)Patients with fasting or nonfasting triglyceride levels greater than 500 mg/dL at screening (within 12 weeks of enrollment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in ALT at 24 weeks (between groups) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. percent change from baseline in ALT at 24 weeks for each group (before/after comparison) 2. percent change from baseline in ALT at 12 weeks (between group comparison) 3. percent change from baseline in ALT at 12 weeks for each group (before/after comparison) 4. percent change from baseline in various biochemical parameters at 24 weeks (group comparison) . 5. percent change from baseline in various biochemical tests at 24 weeks for each group (before/after comparison) 6. percent change from baseline in various biochemical parameters (excluding special tests) at 12 weeks (group comparison) 7. percent change from baseline in biochemical parameters (excluding special tests) at 12 weeks for each group (before and after comparison) | — |
Contacts
Public ContactHirokazu Nishida
Iwama pharmacy
Outcome results
None listed