Dapagliflozin effectiveness on the vascular endothelial function and glycemic control in T2D with moderately inadequate glycemic control
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000018754
- Lead Sponsor
- Japan Society for Patient Report Outcome
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in FMD volume from baseline to the 16-week observation point
- Secondary Outcome Measures
Name Time Method