Type 2 diabetic patients with chronic heart failure
Conditions
Interventions
Group receiving canagliflozin Oral administration of 100 mg canagliflozin once a day, pre or post breakfast
Group receiving glimepiride Oral administration of glimepiride once or twise a day, before
s discretion if necessary. Maxmum dose is 6 mg/day.
Sponsors
Department of Cardiovascular Medicine, Saga University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years or older at consent (male and female) 2) Is diagnosed with type 2 diabetes and the investigator considered that initiation of administrating antidiabetic agents or change or addition of antidiabetic agent is possible 3) Is diagnosed with chronic heart failure (NYHA class is I-III) 4) NYHA functional classification dosn't change in 4 weeks prior to eligibility qualification and dose of heart failure treatment drugs (such as ACE inhibitor, ARB, beta blocker, diuretic etc.) dosn't change 5) The patient provided written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in NT-proBNP from baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in NT-proBNP from baseline to 24 weeks 2) Control of blood glucose HbA1c value after 24 weeks (or at discontinuation) and change in HbA1c from baseline to 24 weeks Following values after 24 weeks (or at discontinuation) and change in them from baseline to 24 weeks fasting plasma glucose, insulin, HOMA-R, HOMA-beta 3) Blood pressure, home blood pressure (optional), and body weight Following values after 24 weeks (or at discontinuation) and change in them from baseline to 24 weeks Blood pressure, home blood pressure (early morning), body weight 4) Serum lipid and serum uric acid level Following values after 24 weeks (or at discontinuation) and change in them from baseline to 24 weeks TC, HDL-C, LDL-C, TG, non-HDL-C, uric acid level 5) QOL score QOL (MLHF) score after 24 weeks (or at discontinuation) and change in QOL (MLHF) from baseline to 24 weeks 6) Heart function LVEF and E/e' values after 24 weeks (or at discontinuation) and change in LVEF and E/e' from baseline to 24 weeks Severity and change in NYHA functional classification from baseline to 24 weeks 7) Renal function Following values after 24 weeks (or at discontinuation) and change in them from baseline to 24 weeks Serum creatinine, eGFR, urine albumin excretion (creatinine corrected value), and urine L-FABP 8) Cardiovascular event occurred from baseline to 24 weeks Nonfatal stroke, nonfatal myocardial infarction, hospitalization because of heart failure, exacerbation of heart failure (adding agents or increasing the dose) 9) All-cause mortality 10) Adverse events and adverse drug reaction from baseline to 24 weeks | — |
Countries
Japan
Contacts
Public ContactKoichi Node
Saga University Department of Cardiovascular Medicine
Outcome results
None listed