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Table 1 Detailed inclusion and exclusion criteria

From: Rationale and design of a randomized trial to test the safety and non-inferiority of canagliflozin in patients with diabetes with chronic heart failure: the CANDLE trial

Inclusion

Exclusion

Adults (aged ≥20 years)

Type 1 diabetes mellitus

T2DM patients who need to start or who are possibly changing or adding an anti-diabetic agent

History of diabetic ketoacidosis, diabetic coma, or hypoglycemic attack ≤6 months prior to informed consent

CHF (NYHA functional classification I to III)

Severe renal dysfunction (eGFR <45 ml/min/1.73 m2) or patients receiving dialysis

Without change in NYHA functional classification or drugs for heart failure 4 weeks prior to eligibility

Severe liver dysfunction (at least threefold higher AST or ALT more than the upper limit of the facilities reference value

The patient provided written informed consent to participate in the study

CHF (NYHA functional classification IV)

Patients with pituitary or adrenal dysfunction

Patients with malnutrition, starvation, irregular eating pattern, lack of dietary intake, or debilitation

Patients with excess alcohol intake

Patients in perioperative period around trial screening

Patients with severe infection or trauma at trial screening

Patients with a gastrointestinal disorder, such as diarrhea or vomiting

Patients with low body weight (BMI <18.5 kg/m2)

History of coronary artery disease, coronary vascularization, open-heart surgery, stroke, or transient ischemic attack ≤3 months prior to eligibility

Patients with a malignancy

History of hypersensitivity to ingredients of SGLT2 inhibitors or sulfonylureas

Pregnant or suspected pregnancy in females

Lactating female

Considered inappropriate for the study by investigators due to other reasons

  1. ALT alanine aminotransferase, AST aspartate transaminase, BMI body mass index, CHF chronic heart failure, eGFR estimated glomerular filtration rate, NYHA New York Heart Association, SGLT2 sodium glucose cotransporter 2, T2DM type 2 diabetes mellitus