Type 2 diabetes
Conditions
Interventions
Dapagliflozin as add-on medication group: Patients enrolled in this group orally take dapagliflozin 5mg once per day in addition to other medications during the 16-week period.
Increase metformin do
Sponsors
Japan Society for Patient Report Outcome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. In addition to a diet and exercise, type 2 diabetes patients who have been treating diabetes a) for more than 12 weeks using 750mg of metformin, or b) with one type of oral hypoglycemic agents* in addition to 750mg of metformin *In the case of SU users, glimepiride (2 mg or less than it) or glimicron (40 mg or less than it) are allowed 2. HbA1c (NGSP values) 6.0% or higher and under 8.0% 3. Males or females aged 20 to 74 4. Patients who can closely follow the medication compliance 5. Patients who can provided written consent to participate in the clinical study
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. Type 1 diabetes or secondary diabetes 2. Had used SGLT2 inhibitors, GLP-1 agonists, or insulin 12 weeks before providing their consent 3. Had used a dose of metformin exceeding 750mg per day 12 weeks before providing their consent 4. Had started taking angiotensin-converting enzyme inhibitor (ACE inhibitor), angiotensin II receptor antagonist (ARB), HMG-CoA reductase inhibitor (statin), or antiplatelet drugs, or had their medication dose changed (including reducing the dose) 12 weeks before providing their consent 5. Patients who have a severe infection, have had or are about to have surgery, or are suffering from a serious trauma 6. With a medical history of myocardial infarction, angina, stroke or cerebral infarction 7. With atrial (chronic) fibrillation, frequent supraventricular or ventricular ectopy 8. With a moderate or severe level of cardiac insufficiency (patients with class III or more as classified by the NYHA/New York Heart Association) 9. Ankle Brachial Pressure Index (ABI)< 0.9 10. Serious liver or renal functional failure (serum creatinine 1.3mg/dL or greater, or eGFR< 45mL/min/1.73 square meters) 11. Unstable blood pressure or lipid abnormalities within 12 weeks before providing their consent 12. Addicted to alcohol or drugs 13. Patients who are pregnant or breastfeeding, or who may be, or plan to be, pregnant 14. Dehydrated (abnormal test results of hematocrit and BUN values, and complaint of symptoms of dehydration) 15. Using diuretics 16. Urinary tract or genital infections within 12 weeks before providing their consent 17. With a past history of hypersensitivity to the study drug 18. At risks of ketoacidosis, diabetic coma or precoma 19. Other conditions considered to be unsuitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FMD volume from baseline to the 16-week observation point | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed