Ipragliflozin for type 2 DM with NAFLD

JRCT ID: jRCTs071180069

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes with nonalcoholic fatty liver disease
• Date of first enrollment: 10/08/2015
• Target sample size: 54
• Study type: Interventional
• Intervention(s): Oral administration of ipragliflozin (50mg tablet) once a day after meal

Outcome(s)

• Primary Outcome: Decrease in HbA1c after interventions for 72 weeks

Secondary Outcome

1. 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
• Gender: Both

Include criteria

1)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 criteria

1)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

• Primary Sponsor: Anzai Keizo
• Secondary Sponsor: Astellas Pharma Inc.
• Secondary ID(s): UMIN00001572