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

JRCT ID: jRCT1061230070

Registered date:31/10/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 31/10/2023
• Target sample size: 20
• Study type: Observational
• Intervention(s): Tofoglifrozin 20mg

Outcome(s)

• Primary Outcome: Fasting hepatic insulin clearance after 24 weeks of treatment
• Secondary Outcome: HOMA-IR after 24 weeks of treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. Type 2 diabetes
2. HbA1c 6.5~10%
3. Diet therapy only, or Metformin, or DPP4 inhibitor

Exclude 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 or sulfonylurea within 24 weeks
12) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Related Information

• Primary Sponsor: Okura Tsuyoshi
• Secondary Sponsor: Kowa Company, Ltd.