Study on the effectiveness of SGLT2 inhibitor, Tofogliflozin, AND Biguanide, metformin for tYpe 2 diabetic patients with NonAlcoholic Fatty Liver Disease

Not Applicable

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-jRCTs031190040
• Lead Sponsor: Yumi Takiyama

Brief Summary

SGLT2 inhibitors tended to reduce liver fat content and liver hardness compared to the control drug metformin, but the number of samples was small, individual differences were large, and statistically significant differences were not observed. Regarding safety, no serious adverse events were observed, and there was no need to change other therapeutic agents.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Study Completion: 2021-02-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Type 2 diabetic patients who satisfy all the following criteria
1.Clinically diagnosed with NAFLD / NASH(within 3 years before informed consent)
2.6.5% < HbA1c < 10.0%
3.8 % < MRI-PDFF(within 12 weeks before informed consent)
4.Patients who can take metformin and tofogliflozin
5.20 years < age
6.Written informed consent

Exclusion Criteria

1.Type 1 diabetes or gestational diabetes
2.Use of SGLT2 inhibitor within 12 weeks before informed consent
3.Use of biguanide within 12 weeks before informed consent
4.Use of GLP-1 receptor agonist within 12 weeks before informed consent
5.Use of Thiazolidine within 12 weeks before informed consent
6.Use of Vitamin E preparation within 12 weeks before informed consent
7.Contraindication to tofogliflozin and metformin
8.Hypersensitivity to tofogliflozin and metformin
9.Absolute indications for insulin treatment
10.History of hypoglycemia with loss of consciousness
11.eGFR < 30mL/min/1.73m2
12.Serious liver functional impairment(Child-Pugh classification B or C)
13.History of cancer or high possibility of cancer recurrence
14.Pregnant, or possibly pregnant, nursing
15.Other ineligibility determined by an investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in liver fat content as measured by MRI-PDFF( proton density fat fraction). <Time frame: 24 weeks, comparison of arm A and B>