Efficacy and safety of dapagliflozin in patients hospitalized with COVID-19 with and without type 2 diabetes: a prespecified analysis of the DARE-19 randomized trial
Authors' conclusion
Initiating dapagliflozin in patients hospitalized for acute COVID-19 was well tolerated and safe, irrespective of T2D status. Serum biomarker levels remained stable and comparable between treatment groups, indicating no increased risk of adverse metabolic or renal effects with dapagliflozin in this clinical scenario.
Study context
- Population
- Patients hospitalized with COVID-19 and cardiometabolic risk factors; T2D in 636/1250 (50.9%)636 with T2D
- Participants
- 1,250 patients
- Comparison
- Dapagliflozin vs placebo in patients with and without T2D
- Primary endpoint
- Dual primary outcomes: prevention (time to new or worsened organ dysfunction or death) and hierarchical composite recovery outcome (change in clinical status)
- Follow-up
- By day 30
Methodological detailsprespecified, double-blind, placebo-controlled, subgroup analysis by T2D status
- Prespecified
- Double-blind
- Placebo-controlled
- Subgroup analysis by T2D status
Primary result
As reported in the abstract
Prevention outcome (new or worsened organ dysfunction or death), by T2D status
Dapagliflozin (T2D) vs Placebo (T2D)
Estimate (95% CI)
Hazard ratio
0.76(0.49–1.18)
Dapagliflozin (no diabetes) vs Placebo (no diabetes)
Estimate (95% CI)P value
Hazard ratio
0.86(0.55–1.35)
interaction p = 0.668- Recovery outcome: no significant differences between dapagliflozin and placebo regardless of diabetes status
- interaction p = 0.222
Further findings
Serum bicarbonate, eGFR, hematocrit · index hospitalization
- Similar for dapagliflozin and placebo, irrespective of T2D status
Safety
| Outcome | Values |
|---|---|
| Any serious adverse event | Dapagliflozin (T2D) 12.7% · Placebo (T2D) 14.3% · Dapagliflozin (no T2D) 8.5% · Placebo (no T2D) 11.9% |
| DKA | Dapagliflozin (T2D) 2 events |
Original publication
Efficacy and safety of dapagliflozin in patients hospitalized with COVID-19 with and without type 2 diabetes: a prespecified analysis of the DARE-19 randomized trial. Cardiovasc Diabetol. Published 30 July 2025. doi:10.
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