Type 2 diabetes
Conditions
Interventions
Subjects will be randomly assigned to either the 'tofogliflozin group' or the 'metformin group' for four weeks of treatment. In the "tofogliflozin group", administration is started at 20 mg/day tofogl
Sponsors
Nakamura Akinobu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 20-90 years old 2) HbA1c 6.5-9.0% and urine ketone negative 3) Patients with type 2 diabetes who have not been taking any hypoglycemic agents more than 3 months 4) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of anaphylaxis of tofogliflozin 2) History of anaphylaxis of metformin 3) History of lactic acidosis 4) Unstable retinopathy 5) Severe hepatic, renal, or cardiac dysfunction 6) Pregnancy or possibly pregnant females 7) Severe ketosis, diabetic coma 8) Severe infection, surgery, serious trauma 9) Deficiency of insulin secretion 10) Dehydration or possibly dehydration 11) Excessive alcohol consumption 12) Malnutrition, starvation, debility, pituitary or adrenal insufficiency 13) Inability to consume an appropriate diet 14) Incompatibility with the trial for other reasons, as determined by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in disposition index at 4 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in the other blood and urinary tests 2) Changes in weight, abdominal circumference, blood pressure and pulse 3) Changes in beta-cell function indices other than the primary endpoint 4) Changes in insulin resistance indices 5) Changes in scores of hepatic steatosis 6) The factors associated with improvement of beta-cell function indices and secondary endopoints 7) Rate of improvement to impared glucose tolerance or normal glucose tolerance | — |
Contacts
Public ContactAkinobu Nakamura
Hokkaido University
Outcome results
None listed