A study on the utilization of canagliflozin in type 1 diabetes mellitus using real‐world data from four European countries

AIMS: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are not approved for glycaemic control in type 1 diabetes mellitus (T1DM), and concerns exist around off-label use in this patient population. The objective of this study was to investigate whether and how canagliflozin, an SGLT2 inhibitor, has been used in patients with T1DM, and whether the off-label use of canagliflozin for T1DM has changed over time. MATERIALS AND METHODS: This observational, retrospective cohort study utilized real-world data from 2016 to 2022 in four European countries (Belgium, Italy, Spain and United Kingdom) with high cumulative exposure to canagliflozin. Analyses were conducted to identify canagliflozin users with T1DM and estimate the prevalence and incidence of off-label use during the entire study period and by year. RESULTS: The overall prevalence and incidence of off-label use of canagliflozin in T1DM were consistently low, ranging from 0.0% to 0.2% across six healthcare databases, using both primary and sensitivity definitions of patients with T1DM. A trend analysis of new users of canagliflozin with T1DM over time was not feasible given that the annual prevalence and incidence calculations for many years were censored. Few (number censored) to no diabetic ketoacidosis (DKA) events were reported among canagliflozin users with T1DM in each database. CONCLUSION: Real-world data analyses from four European countries showed that off-label use of canagliflozin for T1DM was rare.