Ipragliflozin for type 2 DM with NAFLD

Phase 3

• Conditions: Type 2 diabetes with nonalcoholic fatty liver disease

• Registration Number: JPRN-jRCTs071180069
• Lead Sponsor: Anzai Keizo

Brief Summary

A total of 55 patients were included in the current study. In the 51 patients (ipragliflozin=25, control=26) without discontinuation, decrease in HbA1c of ipragliflozin group at 72-week from baseline was not significantly different comparing with the control group. Body weight of ipragliflozin group decreased from baseline significantly more than control group. Patients with improvement of liver fibrosis was significantly more frequent n the ipragliflozin group than the control group.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-03-01
• Study Start: 2019-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 55

Inclusion 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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in HbA1c after interventions for 72 weeks

Secondary Outcome Measures

Name	Time	Method
1. Changes in HbA1c after 12 week, 24 week and 48 week of intervention.<br>2. Changes in bodyweight after 24 week and 72 week of intervention.<br>3. Changes in the parameters described below after 12 week, 24 week, 48 week and 72 week of intervention.<br>Serum liver function test, imaging analysis, serum inflammatory marker, liver histology, serum biochemistry exams, blood counts and adverse events.