Safety of canagliflozin in diabetic patients with chronic heart failure: randomized, non-inferiority trial
- Conditions
- Type 2 diabetic patients with chronic heart failure
- Registration Number
- JPRN-UMIN000017669
- Lead Sponsor
- Department of Cardiovascular Medicine, Saga University
- Brief Summary
This study did not meet the predefined primary endpoint of non-inferiority of canagliflozin vs. glimepiride, pre-defined as a margin of 1.1 in the upper limit of the two-sided 95% confidence interval for the group ratio of percentage change in NT-proBNP at 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 249
Not provided
1) Type 1 diabetes 2) Has history of diabetic ketoacidosis, diabetic coma, or hypoglycemic attack within 6 months 3) With severe renal dysfunction (eGRF < 45 mL/min/1.73m 2 or patient undergoing artificial dialysis) 4) With serious liver disfunction (ASTor ALT is 3 times site reference value or more) 5) Heart failure patient whose NYHA functional classification is IV 6) With pituitary gland dysfunction or adrenal gland dysfunction 7) With malnutrition, starvation, irregular eating pattern, lack of dietary intake, debilitaion 8) Excessive alcohol consumption 9) Is pre or post surgery, has severe infection or sirious trauma at eligibility qualification 10) With gastrointestinal disorder such as diarrhea and vomiting 11) BMI < 18.5 kg/m 2 12) Has history of coronary artery disease, coronary revascularization, cardiotomy, stroke and transient ischemic attacks within 3 months before eligibility qualification 13) Has malignancy 14) Has history of hypersensitivity to canagliflozin, glimepiride or sulfonamides 15) Pregnant, possibly pregnant, planned to become pregmant or nursing women 16) Are considered not eligible for the study by the attending doctor due to other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in NT-proBNP from baseline to 24 weeks
- Secondary Outcome Measures
Name Time Method