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

Effect of tofogliflozin on liver fat content compared to metformin in type 2 diabetes patients with nonalcoholic fatty liver disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190040

Enrollment

Registered

2019-06-17

Start date

2019-10-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Type 2 diabetes mellitus

Interventions

Arm A Tofogliflozin 20mg/day Tofogliflozin 20mg/day + Metformin 1500mg/day Arm B Metformin 500mg/day Metformin 1500mg/day * Tofogliflozin 20mg/day + Metformin 1500mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in liver fat content as measured by MRI-PDFF( proton density fat fraction).	—

Secondary

Measure	Time frame
Important secondary endpoint Change in liver stiffness as measured by MR elastography. Secondary endpoint 1.% change of liver fat content as measured by MRI-PDFF. 2.Change in, and % change of liver fat content as measured by MRI-PDFF. 3.Change in, and % change of liver fat content as measured by MRI-PDFF. 4.% Change of liver stiffness as measured by MR elastography. 5.Change in, and % Change of liver stiffness as measured by MR elastography. 6.Change in, and % change of liver stiffness as measured by MR elastography. 7.Change in, and % change of following parameters. 8.Change in, and % change of following parameters from 24 to 48 weeks. 9.Incidence of adverse events ALT, AST, gamma-GTP, PT, TP, Alb, ChE, type IV collagen 7S, P-III-P, hyaluronic acid Body weight, body mass index, west circumference, blood pressure HbA1c, fasting blood glucose, glycoalbumin, insulin, HOMA-R, CPI TC, HDL-C, LDL-C, TG, RLP-C Serum creatinine, eGFR White blood cell, red blood cell, hemoglobin, hematocrit, platelet Total ketone, beta-hydroxybutyric acid, acetoacetic acid Uric acid BUN, Na, K, P, Ca, Mg, Fe, ferritin, bilirubin fraction Urine sugar, urinary ketone body, urinary albumin Visceral fat area Fat accumulation content of intrahepatic Body fat mass, fat-free mass, muscle mass	—

Measure

Time frame

Important secondary endpoint Change in liver stiffness as measured by MR elastography. Secondary endpoint 1.% change of liver fat content as measured by MRI-PDFF. 2.Change in, and % change of liver fat content as measured by MRI-PDFF. 3.Change in, and % change of liver fat content as measured by MRI-PDFF. 4.% Change of liver stiffness as measured by MR elastography. 5.Change in, and % Change of liver stiffness as measured by MR elastography. 6.Change in, and % change of liver stiffness as measured by MR elastography. 7.Change in, and % change of following parameters. 8.Change in, and % change of following parameters from 24 to 48 weeks. 9.Incidence of adverse events ALT, AST, gamma-GTP, PT, TP, Alb, ChE, type IV collagen 7S, P-III-P, hyaluronic acid Body weight, body mass index, west circumference, blood pressure HbA1c, fasting blood glucose, glycoalbumin, insulin, HOMA-R, CPI TC, HDL-C, LDL-C, TG, RLP-C Serum creatinine, eGFR White blood cell, red blood cell, hemoglobin, hematocrit, platelet Total ketone, beta-hydroxybutyric acid, acetoacetic acid Uric acid BUN, Na, K, P, Ca, Mg, Fe, ferritin, bilirubin fraction Urine sugar, urinary ketone body, urinary albumin Visceral fat area Fat accumulation content of intrahepatic Body fat mass, fat-free mass, muscle mass

—

Contacts

Public ContactMasaru Abe

Asahikawa Medical University

rs-kk.g@asahikawa-med.ac.jp+81-166-68-2261

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026