Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunctio
Not Applicable
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000025808
- Lead Sponsor
- Seino Internal Medicine Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1) Type 1 diabetes 2) Has history of severe ketosis, diabetic coma, or precoma 3) With severe infection, pre or post surgery, and serious trauma 4) With severe renal dysfunction (eGFR<30 mL/min/1.73m2) 5) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months 6) Receiving SGLT2 inhibitor 7) Nursing or pregnant or planning to become pregnant 8) Has hypersensitivity to luseogliflozin or any other excipients of luseogliflozin 9) Considered as inadequate by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change and percent change in AST, ALT, gamma-GTP, and HbA1c from baseline to 52 weeks
- Secondary Outcome Measures
Name Time Method 1) Change in the following items from baseline to 12 and 24 weeks - AST, ALT, gamma-GTP, HbA1c 2) Change in the following items from baseline to 12, 24, and 52 weeks - Fasting plasma glucose, HOMA-beta, HOMA-IR - Body weight, BMI, Waist circumference, and Blood pressure - NAFLD fibrosis score, FIB-4 index, FLI 3) Change in the following items from baseline to 24 and 52 weeks - Type IV collagen 7S domain, Ferritin, M2-BP, hs-CRP 4) Change in IL-6 from baseline to 52 weeks