TABLE 2.
Summary of DKA events a for the DEPICT pooled population
| Week 24 (short‐term period) | Week 52 (short‐term + long‐term period) | |||||
|---|---|---|---|---|---|---|
| DAPA 5 mg (N = 548) | DAPA 10 mg (N = 566) | Placebo (N = 532) | DAPA 5 mg (N = 548) | DAPA 10 mg (N = 566) | Placebo (N = 532) | |
| Patients with adjudicated definite DKA, n (%) | 11 (2.0) | 11 (1.9) | 3 (0.6) | 22 (4.0) | 20 (3.5) | 6 (1.1) |
| Events sent for adjudication, n | 54 | 41 | 28 | 81 | 76 | 40 |
| Number of events of definite DKA, n | 11 | 11 | 3 | 23 | 20 | 6 |
| Incidence rate, per 100 patient‐years | 4.55 | 4.36 | 1.29 | 4.62 | 3.85 | 1.27 |
| Severity of event as adjudicated, n | ||||||
| Mild | 5 | 4 | 1 | 9 | 6 | 3 |
| Moderate | 4 | 4 | 1 | 8 | 10 | 2 |
| Severe | 2 | 3 | 1 | 6 | 4 | 1 |
| Number of events of euglycaemic DKA b , n | 2 | 3 | 0 | 6 | 7 | 1 |
| Primary cause for definite DKA events, n | ||||||
| Insulin pump failure | 3 | 3 | 1 | 4 | 5 | 2 |
| Missed insulin dose | 3 | 4 | 1 | 8 | 5 | 1 |
| Severe illness | 0 | 0 | 0 | 1 | 1 | 0 |
| Not identified | 5 | 0 | 0 | 7 | 3 | 1 |
| Other | 0 | 4 | 1 | 3 | 6 | 2 |
| Mean total insulin dose reduction compared to baseline for week before definite DKA events, % | −13.94 | −23.29 | −7.79 | −3.57 | −21.05 | −10.14 |
| Mean total insulin dose reduction compared with baseline at end of treatment period in patients with definite DKA events, % | −13.80 | −22.39 | 30.76 | −12.08 | −20.43 | 5.07 |
| Events adjudicated as not DKA | ||||||
| Patients with possible DKA, n (%) | 11 (2.0) | 11 (1.9) | 3 (0.6) | 16 (2.9) | 13 (2.3) | 4 (0.8) |
| Number of events of possible DKA, n | 14 | 12 | 5 | 22 | 14 | 6 |
| Patients with improbable DKA, n (%) | 16 (2.9) | 12 (2.1) | 10 (1.9) | 19 (3.5) | 21 (3.7) | 12 (2.3) |
| Number of events of improbable DKA, n | 29 | 18 | 20 | 36 | 42 | 28 |
Abbreviations: DAPA, dapagliflozin; DKA, diabetic ketoacidosis.
a
24‐week data include non‐SAEs seen from day 1 of treatment up to and including 4 days after the last dose in the short‐term period; 52‐week data also include events up to and including 30 days after the last dose in the short‐ +long‐term period.
b
Euglycaemic DKA was defined as having a measured glucose below 250 mg/dL closest to the time of the highest beta‐hydroxybutyrate value.