Type 2 diabetes with nonalcoholic fatty liver disease
Conditions
Interventions
Ipragliflozin 50 mg per day for 24 weeks
Pioglitazone 15-30 mg per day for 24 weeks
Sponsors
Ogawa Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetic patients 2. HbA1c higher than 6.5% and lower than 11.0% 3. BMI higher than 22 and lower than 45 kg/m2 4. Patients who have been treated diet/exercise therapy alone, or patients treated with oral anti-diabetic drugs without SGLT2 inhibitor and thiazolidinedione, and/or insulin therapy at baseline. 5. Patients with NAFLD is suspected by abdominal CT, echo or clinical laboratory tests. 6. Patients who are able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have history or current serious diabetic complication. 2. Patients that insulin dependence is suspected. 3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder. 4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in liver-to-spleen attenuation ratio (L/S ratio) by CT at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in AST, ALT, HbA1c, fasting plasma glucose, bodyweight, abdominal visceral adipose tissue, and subcutaneous adipose tissue at week 24. | — |
Countries
Japan
Contacts
Public ContactDaisuke Ito
Ogawa Red Cross Hospital Department of Internal Medicine
Outcome results
None listed