Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58
Authors' conclusion
The benefits and safety of dapagliflozin were maintained in high-risk patients receiving high-dose or intensive insulin regimens including SA insulin.
Study context
- Population
- Patients with T2D in DECLARE-TIMI 58 who used insulin at baseline; 4,650 (66.3%) on regimens including short-acting (SA) insulininsulin users of 17,160
- Participants
- 7,013 patients
- Comparison
- Dapagliflozin vs placebo by baseline insulin regimen and dose
Methodological detailsCox regression models
- Cox regression models
Primary result
As reported in the abstract
Cardiovascular (CV) death/hospitalization for HF, by insulin regimen and dose · median follow-up 4.2 years
Dapagliflozin vs PlaceboHazard ratio (95% CI)P value
Overall insulin users
0.82(0.69–0.97)
Regimens with SA insulin
0.83(0.67–1.03)
P = 0.75for interactionRegimens without SA insulin
0.78(0.57–1.07)
P = 0.75for interaction- No heterogeneity by insulin dose
- P for interaction = 0.43
Further findings
| Outcome | HR (CI) | |
|---|---|---|
| MACE among insulin users | 0.84 (0.74–0.97) | |
| 0.512Hazard ratio (log scale) |
- MACE among insulin users — Similar irrespective of regimen or dose
- Pinteraction = 0.75 and 0.07
Adverse renal outcomes
- Dapagliflozin reduced the rate overall and consistently across subgroups of insulin users
HbA1c, weight and systolic BP
- Decreases with dapagliflozin regardless of insulin dose or regimen
Safety
- Known safety profile of dapagliflozin unchanged in patients on intensive insulin regimens
Original publication
Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58. Diabetes Care. Published 18 November 2022. doi:10.
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