Type 2 diabetes
Conditions
Interventions
Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast
Sponsors
Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes 2) Aged from 20 to 75 years at providing consent 3) Poorly controlled patients who undergoes diet/ exercise therapy, hypoglycemic agents, insulin, or GLP-1 agonist therapy at least 12 weeks 4) HbA1c >=6.5% and <9.5% 5) BMI>=22 kg/m2 6) Provide written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from 0 to 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactSakaguchi Kazuhiko
Kobe University Graduate School of Medicine Department of Internal Medicine
Outcome results
None listed