Type 2 diabetes
Conditions
Interventions
Pemafibrate group
control group
Sponsors
Department of Endocrinology and Metabolism, Dokkyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Type 2 diabetic patients with NAFLD with inadequate lipid control despite being treated with diet, nursing home, or diabetes medication (HbA1c 7.0% or higher) 2)Over 20 years old and less than 80 years old 3)Sex unquestioned 4)Patients with no history of cardiovascular disease 5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization. 6)The patient who gives a written informed
Exclusion criteria
Exclusion criteria: 1)Type 1 diabetes 2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 3)A pregnant woman and/or a woman under breast-feeding 4)Impaired kidney function (serum creatinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women) 5)Diabetic proliferative retinopathy 6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug 7)No treatment with other fibrate 8)Patient with intolerance of medical reasons by doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of changes in liver steatosis by controlled attenuation parameter(CAP) and liver fibrosis measurement (LSM) in Fibro scan | — |
Countries
Japan
Contacts
Public ContactTeruo Jojima
Dokkyo Medical University Department of Endocrinology and Metabolism
Outcome results
None listed