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The effects Of sodium-glucose coTransporter 2 inhibiTOR on fastIng Hepatic Insulin Clearance in type 2 diabetes

The effects Of sodium-glucose coTransporter 2 inhibiTOR on fastIng Hepatic Insulin Clearance in type 2 diabetes - TOTTORI-HIC study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1061230070
Enrollment
20
Registered
2023-10-31
Start date
2023-10-31
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

Tofoglifrozin 20mg

Sponsors

Okura Tsuyoshi
Lead Sponsor
Kowa Company, Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes This study will include patients who meet all the following criteria: 2. Age 18-80 years old 3. HbA1c 6.0~10% 4. Diet therapy only, or anti-diabetic medicine, after 12 weeks. Patients who, despite undergoing treatment with diet and exercise therapy, or diet and exercise therapy in addition to other diabetes medications for more than 12 weeks, have not achieved the glycemic control targets set in the Diabetes Treatment Guidelines 2022-2023 and are scheduled to receive tofogliflozin.

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes 2) Severe ketosis, diabetic coma within the past 24 weeks 3) Severe infection, operation, severe trauma 4) Pregnancy 5) Severe liver dysfunction 6) Severe renal dysfunction 7) Highper sensitivity to SGLT2 inhibitor 8) Urinary tract infection, genital infection 9) Malignancy 10) Administration history of SGLT2 inhibitor within 24 weeks 11) Administration history of insulin injection within 24 weeks 12) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Design outcomes

Primary

MeasureTime frame
Fasting hepatic insulin clearance after 24 weeks of treatment

Secondary

MeasureTime frame
HOMA-IR after 24 weeks of treatment

Contacts

Public ContactTsuyoshi Okura

Division of Cardiovascular Medicine, Endocrinology and Metabolism, Tottori University Faculty of Medicine

ohkura@tottori-u.ac.jp+81-859386517

Outcome results

None listed

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