Real-world safety of dapagliflozin plus metformin in patients of type 2 diabetes mellitus in China: Post-hoc analysis of the DONATE study
Authors' conclusion
Dapagliflozin and metformin combination therapy is well-tolerated in real-world Chinese T2DM patients.
Study context
- Population
- Chinese T2D patients receiving dapagliflozin in DONATE (n = 2,990), of whom 2,165 (72.4%) received concomitant metforminof 2,990 in DONATE
- Participants
- 2,165 patients
- Primary endpoint
- Safety outcomes:
- AEs
- Serious AEs
- AEs leading to dapagliflozin discontinuation
Methodological detailslarge-scale
- Large-scale
Primary result
As reported in the abstract
Safety in patients on dapagliflozin + metformin
≥1 adverse event (AE)
780
36.0%
Serious AE
129
6.0%
AE leading to dapagliflozin discontinuation
96
4.4%
Further findings
Dapagliflozin + metformin dual-therapy subgroup
- AE
- 26.7%
- Serious AE
- 2.5%
- AE leading to dapagliflozin discontinuation
- 1.9%
- Numerically lower than total population and most other dual-therapy subgroups
- Numerically improved metabolic outcomes vs baseline
Safety
Most common AEs
- Upper respiratory tract infection
- 4.0%
- Urinary tract infection (UTI)
- 2.1%
- Constipation
- 1.5%
Most common AEs of special interest of dapagliflozin
- UTI
- 2.3%
- Genital tract infection
- 1.5%
- Hypoglycaemia
- 1.1%
Original publication
Real-world safety of dapagliflozin plus metformin in patients of type 2 diabetes mellitus in China: Post-hoc analysis of the DONATE study. Diabetes Res Clin Pract. Published 13 December 2024. doi:10.
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