Adults with type 2 diabetes
Conditions
Interventions
In addition to current diet therapy and exercise therapy, dapagliflozin 5 mg is administered once a day for 12 weeks.
Current diet therapy, exercise therapy and diabetes therapeutic drug are continued
Sponsors
Non-Profit Organization West Tokyo Diabetes Association
Metabolic Signal Research Center, Institute for Molecular and Cellular Regulation, Gunma University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetic patients whose HbA1c is in a constant range from 6.5% to 8.5% 2) Patients whose age is over 20 years but under 75 years old 3) Patients from whom consent for participating in this study was obtained in writing
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetic patients 2) Patients who were administered SGLT2 inhibitor within 8 weeks before starting the treatment. (prior treatment with SGLT2 should have not been stopped due to intolerable side effects). 3) Patients whose eGFR is <45ml/min/1.73 m2 4) Patients with history of severe liver problems as shown below Patients whose AST and/or ALT exceeds 3-fold of upper limit of facility standard value Patients whose total bilirubin exceeds 2.0 mg/dL (34.2 &micro;mol/L) 5) Patients who have medical history of hypersensitivity to the ingredients of SGLT2 inhibitor 6) Patients with severe ketosis, diabetic coma or precoma 7) Patients with severe infectious disease and serious trauma, and perioperative patients 8) Patients suffering from shock, cardiac insufficiency, myocardial infarction, cardiovascular system problems including pulmonary embolism, and severe insufficiency in pulmonary function, and patients whose conditions easily develop other hypoxemia 9) Patients who are in the status of bad nutrition, starvation, irregular meal intake, lack of the dietary intake, and hyposthenia 10) Patients with pituitary gland dysfunction or adrenal gland dysfunction 11) Patients who drink alcohol excessively including alcohol abuse 12) Patients with dehydration, gastrointestinal disorder including diarrhoea, vomiting due to which dehydration state is concerned 13) Patients with malignancies 14) Pregnant patients, patients who may be pregnant, and patients with breast-feeding 15) Patients who are judged inadequate in participating in this study by their doctors in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inter-group comparison of the change of total calorie intake during 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint Intergroup comparison of the change of following items before and after the therapy 1) A nutritional status based on BDHQ 2)Body weight, blood pressure, abdominal circumference, grip strength 3) Blood sugar profile (HbA1c, PG) 4) Lipid profile (TC, HDL-C, TG) Exploratory endpoint Intergroup comparison of the change of following items before and after the therapy 1) Body composition 2) Basal metabolism 3) Amount of physical activity 4) Glucagon Relationship with BDHQ variation Variations of body weight and abdominal circumference, and variation of BDHQ | — |
Countries
Japan
Contacts
Public ContactNaohide Noumi
IBEC Co., Ltd. CEO Office
Outcome results
None listed