type 2 diabetes mellitus
Conditions
Interventions
Dapagliflozin is orally administered for 8 weeks in the dose of 5mg per day if there is no serious event included in termination criteria. If the effect for improving diabetes is insufficient, it is a
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects with type 2 diabetes mellitus of from 20 to 65 years of age. 2. Patients who have not achieve the clinical target of the glycemic control (less than 7.0% in HbA1c). 3. Patients who received the diet therapy, the exercise therapy or the following anti-diabetic drugs in addition to the diet and/or exercise therapy (up to two drugs) with dosage stable for 8 weeks prior to entry. a. Sulfonylurea (Glymepiride 2mg/day or less, Glibenclamide 1.25mg/day or less, Gliclazide 40mg/day or less) b. Thiazolidine (Actos) c. Biganide (Metformin, Buformin) d. alpha-glucosidase inhibitor (Voglibose, Miglitol, Acarbose) e. DPP4 inhibitors (Sitagliptin, Linagliptin, Anagliptin, Teneligliptin, Alogliptin, Saxagliptin) 4. Informed consent to participate in the study prior to any study procedures.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus 2. Moderate or severe renal dysfunction (eGFR<45 ml/min/1.73m2 or hemodialysis) 3. Severe hepatic insufficiency (AST and/or ALT >3x upper limit of normal) 4. Adrenal insufficiency or pituitary gland dysfunction 5. Malnourishment, starvation, irregular dietary intake, poor dietary intake, debilitating condition or a severe muscle movement 6. Volume depleted patients; concomitant medication such as loop diuretics. 7. Excessive alcohol intake (>60g daily) 8. SGLT2 inhibitors such as dapagliflozin are already administered 9. Contraindication with dapagliflozin 10. Start a new medication of statins, fibratesm ezetimibe or probucol within a month 11. Females who are likely to be pregnant, during pregnancy or lactating 12. Participants in other clinical trials 13. Inability to communicate and comply with all study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine changes of fasting lipoprotein profile by the administration of dapagliflozin; Concentrations of apoB-48 and RemL-C by examining before and 4 and 8 weeks after the administration of dapagliflozin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Following points will be examined before and 4 and 8 weeks after the administration of dapagliflozin. 1. To examine changes of fasting glucose and HbA1c (NGSP) level by the administration of dapagliflozin 2. To examine changes of fasting lipid profile by the administration of dapagliflozin; Concentrations of TG, TC, HDL-C and LDL-C 3. To examine changes of fractions of free fatty acids, protein mass of LPL, and lipoprotein profile assessed by the HPLC by the administration of dapagliflozin 4. To examine changes of biomarkers for renal and hepatic function by the administration of dapagliflozin 5. To examine the frequency of adverse effects by the administration of dapagliflozin | — |
Countries
Japan
Contacts
Public ContactDaisaku Masuda
Osaka University Graduate School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed