Real-world safety of dapagliflozin plus metformin in patients of type 2 diabetes mellitus in China: Post-hoc analysis of the DONATE study

Aim: DONATE (NCT03156985) is a large-scale real-world study investigating the safety of dapagliflozin in Chinese type 2 diabetes mellitus (T2DM) patients. This post-hoc analysis aims to further evaluate the real-world safety of dapagliflozin plus metformin. Methods: Safety outcomes were assessed in patients receiving concomitant dapagliflozin and metformin, with or without other antidiabetics. The safety of dapagliflozin-based dual-therapies and dapagliflozin and metforminbased triple-therapies were also analysed. Results: Among the 2,990 patients in DONATE, 2,165 (72.4%) received concomitant metformin. Among these 2,165 patients, 780 (36.0%) experienced >= 1 adverse event (AE), 129 (6.0%) experienced serious AE (SAE), and 96 (4.4%) experienced AE leading to dapagliflozin discontinuation. The most common AEs were upper respiratory tract infection (4.0%), urinary tract infection (UTI, 2.1%) and constipation (1.5%). The most common AEs of special interest of dapagliflozin were UTI (2.3%), genital tract infection (1.5%) and hypoglycaemia (1.1%). In the dapagliflozin and metformin dual-therapy subgroup, the incidences of AE, SAE and AE leading to dapagliflozin discontinuation were 26.7%, 2.5%, and 1.9%, respectively, numerically lower than that of the total population and most other dual-therapy subgroups. These patients also had numerically improved metabolic outcomes than baseline. Conclusion: Dapagliflozin and metformin combination therapy is well-tolerated in real-world Chinese T2DM patients.