Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD)

Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD) - Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000048523

Enrollment

Registered

2022-08-04

Start date

2022-08-04

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

Interventions

Tofogliflozin 20 mg once in the morning for 10 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patient with Type 2 diabetes with HbA1c level of 7.0 or more and less than 11.0 who were required to be hospitalized for glycemic control 2.Patients with Fatty Liver Index of 30 or higher 3.Patients who drink less than 30g / day for men and 20g / day for women in terms of ethanol

Exclusion criteria

Exclusion criteria: 1.Patients with hypersensitivity to tofogliflozin 2.Patients with contraindications to tofogliflozin 3.Patients with severe renal dysfunction eGFR oh less than 30 or end stage renal disease during dialysis 4.Patients with autoimmune hepatitis, viral liver disease, drug induced fatty liver, primary biliary cirrhosis, and metabolic liver disease 5.Patients who have been treated with SGLT2 inhibitor, GLP1 receptor agonist, and thiazolidine within 3 months before enrollment 6.Patients who the doctor deems inappropriate for participation in this study

Design outcomes

Primary

Measure	Time frame
Change in area under the curve of incremental blood glucose 2 hours after each meal before and after administration of tofogliflozin	—

Secondary

Measure	Time frame
The following degrees of change Glycoalbumin Blood glucose level 180 mg / dl or higher, 70-180 mg / dl, time ratio less than 70 mg / dl, blood glucose level less than 54 mg / dl time ratio, nighttime hypoglycemic region time ratio, average blood glucose level, blood glucose standard Deviation, blood glucose fluctuation coefficient, MODD, M value, MAGE, body weight, urinary glucose excretion Examine the relationship between the above evaluation indicators and the FLI value at baseline (FLI value 30-60, 2 groups of 60 or more, etc.)	—

Measure

Time frame

The following degrees of change Glycoalbumin Blood glucose level 180 mg / dl or higher, 70-180 mg / dl, time ratio less than 70 mg / dl, blood glucose level less than 54 mg / dl time ratio, nighttime hypoglycemic region time ratio, average blood glucose level, blood glucose standard Deviation, blood glucose fluctuation coefficient, MODD, M value, MAGE, body weight, urinary glucose excretion Examine the relationship between the above evaluation indicators and the FLI value at baseline (FLI value 30-60, 2 groups of 60 or more, etc.)

—

Countries

Japan

Contacts

Public ContactKawaguchi Yuji

Minami Osaka Hospital Internal medicine

y.kawaguchi@minamiosaka.com0666850221

Outcome results

None listed

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