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SGLT2 Inhibitor Versus Sulfonylurea on Type 2 Diabetes With NAFLD

NCT02649465 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-02

No results posted yet for this study

Summary

The clinicopathological analyses revealed that reduction in HbA1c and use of insulin independently contribute to the reduction in liver fibrosis scores during the histological course of NAFLD development. These findings led us to hypothesize that glycemic control and insulin ameliorate or protect against the histological progression of liver fibrosis in patients with NAFLD.

In the present study, we investigated the efficacy of SGLT2 inhibitor tofogliflozin and sulfonylurea glimepiride, which lower glucose levels similarly with reduction and elevation in circulating insulin levels, respectively, in NAFLD patients with type 2 diabetes for 48 weeks by examining liver histology, as well as hepatic enzymes, metabolic markers, and hepatic gene expression profiles.

Conditions

  • Non-alcoholic Fatty Liver Disease

Interventions

DRUG

Tofogliflozin

The group receiving Tofogliflozin (at a dose of 20mg once daily) for 48 weeks

DRUG

Glimepiride

Sulfonylurea dosage (Glimepiride): dosing from 0.5 mg for initial 4 weeks. Then, if there is no adverse effect or no improvement of glucose metabolism, glimepiride is escalated to 6 mg once daily.

Sponsors & Collaborators

  • Kowa Company, Ltd.

    collaborator INDUSTRY

  • Kanazawa University

    lead OTHER

Principal Investigators

  • Toshinari Takamura, MD,PhD · Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-11
Primary Completion
2020-12-28
Completion
2021-06-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649465 on ClinicalTrials.gov