A study on the efficacy and biogenic adaptability affected by ipragliflozi
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000015478
- Lead Sponsor
- Kobe University
- Brief Summary
After SGLT2 inhibitor adoministration, appetite of participants increased, and the level of plasma leptin levels increased.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 104
Not provided
1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma within 6 months 3) With severe infection, pre or post surgery, and serious trauma 4) With severe hepatic dysfunction 5) With renal dysfunction (Serum Creatinine male: >= 1.5 mg/dL, female: >= 1.3 mg/dL) 6) Is receiving steroids 7) Has history of gastrectomy (include segmentectomy and total resection, but not endoscopic mucosal resection) 8) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months at consent 9) Has history of receiving SGLT-2 inhibitor 10) Is pregnant, nursing, or planned to become pregnant 11) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 12) Considered as inadequate by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from 0 to 16 weeks
- Secondary Outcome Measures
Name Time Method Percent change in HbA1c, and change and percent change following items during the investigational period 1) Fasting plasma glucose, serum insulin, glucagon, CRP, and GA 2) Body weight 3) Serum lipid (TC, LDL-C, TG, HDL-C) 4) Blood pressure 5) Appetite-related hormone (active ghrelin, and leptin) 6) Erythropoietin, reticulocyte 7) Appetite related visual analogue scale at fasting 8) Blood ketone bodies fraction 9) Urinary ketone, urinary sediment (bacteria, WBC) 10) Electrolyte in blood and spot urine, serum osmotic pressure, NT-proBNP, urinary creatinine, urinary glucose