Dapagliflozin and metformin combo well-tolerated and associated with decreased risk of adverse events: Study

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 further to evaluate the real-world safety of dapagliflozin plus metformin.

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 metformin-based 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. Dapagliflozin and metformin combination therapy is well-tolerated in real-world Chinese T2DM patients.

Reference:

Lixin Guo, Jing Wang, Li Li, Lin Yuan, Sheng Chen, Hui Wang, Tonghuan Li, Lin Qi, Hong Yang. Real-world safety of dapagliflozin plus metformin in patients of type 2 diabetes mellitus in China: Post-hoc analysis of the DONATE study, Diabetes Research and Clinical Practice,  Volume 219, 2025, 111959, ISSN 0168-8227, https://doi.org/10.1016/j.diabres.2024.111959.