Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD)
Not Applicable
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000048523
- Lead Sponsor
- Minami Osaka Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in area under the curve of incremental blood glucose 2 hours after each meal before and after administration of tofogliflozin
- Secondary Outcome Measures
Name Time Method 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.)