type 2 diabetes mellitus
Conditions
Interventions
Orally take a dose of 5mg of dapagliflozin once a day before or after breakfast in addition to the medicines taken at time of consenting. If the blood glucose levels are high in patients after a mont
Sponsors
St. Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Type 2 diabetic patients with insufficient glycemic control (HbA1c 7.0 to 10.0%) and BMI 22 kg/m2 and over 2)Patients who are administrating more than or equal to 750mg of metformin, or who aren't receiving metformin thrapy 3)over 20 and under 65 years old 4)outpatient 5)male and female
Exclusion criteria
Exclusion criteria: 1)patients who administrating less than 750mg of metformin 2)patients who receive insulin injection therapy 3)hypersensitivity to study drugs on this study, 4)severe ketosis and diabetic coma or pre-coma 5)serious infective diseases, serious injury, pre- and per-operation 6)pregnancy, nursing woman or possibly pregnant woman 7)moderate or severe renal dysfunction (eGFR: less than 30 mL/min/1.73m2) 8)patients who receive steroids, growth hormone secretagogue, sex hormone agents 9)patients who are inadequate to enter this study due to the other reasons by physician's judgments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the changes in total body muscle mass evaluated by dual-energy x-ray absorptiometry (DXA) before and after 24 weeks between the two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the changes in quadriceps muscle strength measured by a hand-held dynamometer before and after 24 weeks between the two groups | — |
Countries
Japan
Contacts
Public ContactHisashi Fukuda
St. Marianna University School of Medicine Division of Metabolism and Endocrinology, Department of Internal Medicine
Outcome results
None listed