Type 2 diabetes mellitus
Conditions
Interventions
Tofogliflozin 20mg/day.
Sponsors
NHO Kyoto Medical Center, Diabetes Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes mellitus. 2) Patients using DPP-4 inhibitor and/or sulfonyl urea and/or insulin for 3 month or more prior to the moment of starting tofogliflozin. 3) Patients with the HbA1c levels of 7.0% or more, and less than 10.0%, at the moment of starting tofogliflozin. 4) Patients aged 20 years old or more, and less than 75 years old at the moment of starting tofogliflozin. 5) Patients who provided written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients using pharmaceuticals to treat diabetes mellitus other than DPP-4 inhibitor and sulfonyl urea and insulin (including GLP-1 receptor agonist) for 3 month or more prior to the moment starting tofogliflozin. 2) Patients with the serum creatinine levels of 2.0 mg/dl or more. 3) Patients with hypothyroidism. 4) Patients with hyperthyroidism. 5) Patients with BMI less than 18.5 kg/m2, or 40 kg/m2 or more. 6) Patients who have allergy to tofogliflozin. 7) Patients with severe ketosiss, diabetic coma or impending diabetic coma. 8) Patinets with severe infection, in perioperative period, or with severe trauma. 9) Patients to whom participating this study is considered to be inappropriate for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the diabetes treatment satisfaction measured by DTSQ after 12 month of adding tofogliflozin. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in the diabetes treatment satisfaction measured by DTSQ after 3 month of adding tofogliflozin. 2) Change in the eating behavior survey, the food frequency survey, the QOL self-administered questionnaire, and International Prostate Symptom Score. 3) Correlation between the change in the quality of life and the glycemic control, the body weight and the body composition. 4) Correlation between the change in the eating behavior and the glycemic control, the body weight and the body composition. 5) Correlation between the change in the energy intake and the glycemic control, the body weight and the body composition. 6) Change in the markers of the glycemic control, blood sample analysis, body composition, capability to secrete insulin, special blood sample analysis, urine sample analysis and medication adherence. | — |
Countries
Japan
Contacts
Public ContactTakashi Murata
NHO Kyoto Medical Center Diabetes Center
Outcome results
None listed