BACKGROUND AND AIMS: CanCARE is a Canadian multicenter, prospective cohort study that enrolled SGLT2 inhibitor-naïve adult patients with T2DM, with HbA1c ≥7% on a stable anti-hyperglycemic agent (AHA) regimen at baseline and eGFR ≥ 60 mL/min/1.73m2 , who were initiated on CANA as part of their usual treatment.
MATERIALS AND METHODS: This real-world (RW) study assessed the effectiveness and safety outcomes of the enrolled cohort of 527 subjects (mean age 60.7 yrs, mean baseline A1c 8.3%) over 12 months.
RESULTS: Mean A1c reduction was -1.06 (1.12), with an observed dose response: -0.96 for CANA 100mg, -1.20 for CANA 300mg. 84.9%, 57.9% and 33% of subjects experienced >0%, ≥3%, ≥5% weight loss, respectively. Overall, 38.8% of subjects achieved A1c <7.0%, while 41% achieved the composite endpoint of A1c reduction ≥ 0.5%, body weight loss ≥ 3%. 17.9% subjects discontinued CANA. Safety data showed 37.4% subjects had ≥ 1 Adverse Event (AE), 3.5% had serious AEs, 14.5% had AEs special Interest: GMI (9.5%), polyuria (3.7%), UTI (1.5%), severe hypoglycemia (0.9%) and volume-related AE (0.7%). No reports to date of diabetic ketoacidosis or amputations.
CONCLUSIONS: CANA shows sustained, clinical meaningful improvement in cardiometabolic (CM) parameters in the RW, confirming findings from Phase 3 trials.