Table 3

Summary of DKA events*

Dapagliflozin 5 mg (n = 277)Dapagliflozin 10 mg (n = 296)Placebo (n = 260)
Patients with events sent for adjudication, n (%)24 (8.7)28 (9.5)9 (3.5)
Patients with definite DKA, n (%)11 (4.0)10 (3.4)5 (1.9)
Definite DKA events, n12105
Incidence rate, per 100 patient-years4.763.672.15
Severity of event as adjudicated, n
 Mild523
 Moderate361
 Severe421
Euglycemic DKA events, n351
Primary cause for definite DKA events, n
 Insulin pump failure322
 Missed insulin dose441
 Severe illness000
 Not identified320
 Other222
Mean percent total insulin dose reduction compared with baseline
 For the week before definite DKA events, %10.21−23.05−11.63
 At end of week 52 in patients with definite DKA events, %−11.89−17.575.05
Events adjudicated as not DKA
 Patients with possible DKA, n (%)8 (2.9)9 (3.0)2 (0.8)
 Possible DKA events, n13104
 Patients with unlikely DKA, n (%)9 (3.2)11 (3.7)3 (1.2)
 Unlikely DKA events, n16157
  • *Includes events with onset on or after day 1 of the treatment period up to and 30 days after the last dose date in the treatment period.

  • †Self-monitored blood glucose <250 mg/dL (13.9 mmol/L).

  • ‡The increase seen is due to an outlier: one patient had a very large increase in insulin dose, 188.9%, 1 week before the DKA event.