Type 2 Diabetes
Conditions
Interventions
Intervention type:
Name of intervention:
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Frequency of use:
Sponsors
Nagoya Medical Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Patients with type 2 diabetes *Age 20 years or older *The patients that diabetes treatment does not have a change more than the past two months * In more than 6.0% and regulation are less than +-10% of patients each HbA1c of most recent two times *Ability to give written informed consent
Exclusion criteria
Exclusion criteria: *Patients with type 1 diabetes *History of severe ketosis, diabetic coma or previous coma within 6 months *Patients with severe infectious disease ,before or after surgery, or sever trauma *Occurrence of stroke, myocardial infarction or vascular complication required hospitalization within 6 months *Under treatment with SGLT-2 inhibitors *Pregnant, women on lactation or possibly pregnant women, or plan to pregnant during the study *History of hypersensitivity to tofogliflozin *Ineligible patients according to the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Change in HbA1c level from baseline to 12months *Number of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the amount or ratio of the following biomakers from baseline to 3 months,12 months: *HbA1c (except in the case of 12 months), Blood glucose level,*Body weight and waist circumference, *Serum lipid level (TC, TG, HDL-C),*Blood pressure *Renal function (eGFR, BUN, Serum creatinine) | — |
Countries
Japan
Contacts
Public Contactyoshihiko hori
Nagoya Medical Association
Outcome results
None listed