Table 2.
Treatment-emergent hypoglycemic events
| Faster aspart (mealtime) |
Faster aspart (postmeal) |
IAsp (mealtime) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | % | E | R | n | % | E | R | n | % | E | R | |
| Treatment-emergent hypoglycemia | ||||||||||||
| Severe* | 3 | 1.1 | 3 | 0.02 | 8 | 3.1 | 8 | 0.06 | 4 | 1.6 | 4 | 0.03 |
| Severe or BG confirmed | 228 | 87.4 | 3,583 | 27.91 | 227 | 88.0 | 3,594 | 28.15 | 217 | 84.1 | 3,276 | 25.66 |
| Daytime | 226 | 86.6 | 3,187 | 24.82 | 224 | 86.8 | 3,117 | 24.42 | 217 | 84.1 | 2,963 | 23.21 |
| Nocturnal† | 112 | 42.9 | 396 | 3.08 | 125 | 48.4 | 477 | 3.74 | 104 | 40.3 | 313 | 2.45 |
| Meal-related severe or BG-confirmed hypoglycemia | ||||||||||||
| Within 1 h after a meal | 64 | 24.5 | 119 | 0.93 | 46 | 17.8 | 66 | 0.52 | 62 | 24.0 | 105 | 0.82 |
| Within 2 h after a meal | 161 | 61.7 | 717 | 5.58 | 136 | 52.7 | 505 | 3.96 | 147 | 57.0 | 601 | 4.71 |
| Within 4 h after a meal | 200 | 76.6 | 1,777 | 13.84 | 201 | 77.9 | 1,782 | 13.96 | 191 | 74.0 | 1,668 | 13.07 |
Safety analysis set. %, percentage of participants; E, number of events; R, event rate per patient-year of exposure.
Treatment emergent was defined as an event that had onset up to 1 day after the last day of randomized treatment and excluding the events occurring in the run-in period. BG-confirmed hypoglycemia was defined as an episode with a plasma glucose value of <3.1 mmol/L (<56 mg/dL) with or without symptoms consistent with hypoglycemia.
*Severe according to ISPAD 2014.
†Nocturnal severe or BG-confirmed hypoglycemia was statistically significantly different in favor of mealtime IAsp vs. postmeal faster aspart (estimated rate ratio 1.50 [95% CI 1.09; 2.08], P = 0.014).