Real-World Safety of the Combined Use of Dapagliflozin and Metformin in Type 2 Diabetes Mellitus Patients in China-Post Hoc Analysis of the DONATE Study

Background: Dapagliflozin is effective and well-tolerated in type 2 diabetes mellitus (T2DM) patients and is often combined with metformin in clinical practice, with or without other antidiabetic agents. Yet, real-world data on the safety of the combined use of dapagliflozin and metformin are limited. Methods: The DONATE study assessed the safety of dapagliflozin in 2,990 Chinese T2DM patients who received ≥1 dose of dapagliflozin. This post-hoc analysis assessed the incidences of adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) during the 24-week follow-up in patients receiving both dapagliflozin and metformin, with or without other antidiabetic agents. Results: In total, 2,165 patients (72.4%) from the DONATE study received both dapagliflozin and metformin. Comparable with that observed in the overall population, of these patients, 780 (36.0%) had ≥1 AE: 197 (9.1%) were drug-related as judged by the investigator, 129 (6.0%) were serious, and 96 (4.4%) resulted in treatment discontinuation. Urinary tract infections (UTIs), genital tract infections (GTIs) and hypoglycaemia developed in 50 (2.3%), 32 (1.5%), and 23 (1.1%) patients, respectively. In patients receiving dapagliflozin and metformin without other antidiabetic agent (n=322), 86 (26.7%) had ≥1 AE: 12 (3.7%) were drug-related as judged by the investigator, 8 (2.5%) were serious, and 6 (1.9%) resulted in treatment discontinuation. UTIs, GTIs, and hypoglycaemia developed in 4 (1.2%), 2 (0.6%), and 1 (0.3%) patient, respectively. The incidences of AEs, SAEs, and AESIs were also low when dapagliflozin and metformin were used together with dipeptidyl peptidase-4 inhibitor (DPP-4i, 37.5%, 3.1%, and 6.9%) or insulin (36.5%, 7.1%, and 5.0%). Conclusion: The combined use of dapagliflozin and metformin, with or without other antidiabetic agents such as DDP-4i or insulin, showed a good safety profile in Chinese T2DM patients in the real world. Disclosure L. Guo: None. J. Wang: None. L. Li: None. L. Yuan: None. S. Chen: None. H. Wang: None. T. Li: None. L. Qi: None. H. Yang: None.