NIPH Clinical Trials Search

JRCT ID: jRCTs071180069

Registered date:20/03/2019

Ipragliflozin for type 2 DM with NAFLD

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedType 2 diabetes with nonalcoholic fatty liver disease
Date of first enrollment10/08/2015
Target sample size54
Countries of recruitment
Study typeInterventional
Intervention(s)Oral administration of ipragliflozin (50mg tablet) once a day after meal


Primary OutcomeDecrease in HbA1c after interventions for 72 weeks
Secondary Outcome1. Changes in HbA1c after 12 week, 24 week and 48 week of intervention. 2. Changes in bodyweight after 24 week and 72 week of intervention. 3. Changes in the parameters described below after 12 week, 24 week, 48 week and 72 week of intervention. Serum liver function test, imaging analysis, serum inflammatory marker, liver histology, serum biochemistry exams, blood counts and adverse events.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
Include criteria1)Type 2 diabetes patients who received diet+exercise therapy or diet+ exercise + medication for 12 weeks or longer 2)Patients with HbA1c is 6.0% or higher 3)Patients with liver nonalcoholic fatty liver disease diagnosed with liver biopsy which was performed within past 6 months before study inclusion. 4)Age between 20 and 80 years 5)Patients who understand the contents of informed consent form and who can voluntarily sign informed consent form
Exclude criteria1)Patients with severe diabetic complication except simple diabetic retinopathy 2)Patients with history of severe cardiovascular event 3)Patients with history of allergic response to ipragliflozin 4)Patients who requires insulin treatment including diabetic ketoacidosis, severe diabetic ketoacidosis, diabetic coma, pre-diabetic coma, type 1 diabetes, severe infection disease, severe trauma and/or indication of emergency surgery 5)Patients with severe liver and/or renal disfunction 6)Patients with viral hepatitis C and/or viral hepatitis B infection 7)Patients who the investigator determined difficult to participate in the study 8)Patients who had medication with SGLT2 inhibitor and/or thiazolidinedione within 12 weeks before enrollment.

Related Information


Public contact
Name Hirokazu Takahashi
Address 5-1-1 Nabeshima, Saga City, Saga Saga Japan 849-8501
Telephone +81-952-31-6511
Affiliation Saga University Hospital
Scientific contact
Name Keizo Anzai
Address 5-1-1 Nabeshima, Saga City, Saga Saga Japan 849-8501
Telephone +81-952-31-6511
Affiliation Saga University Hospital