Table 2

Treatment-emergent hypoglycemic episodes

HypoglycemiaFAIAsp
n%ERn%ER
Severe162.9180.11101.8140.08
Severe or BG confirmed
 Overall36767.52,22713.4039171.92,74916.52
 Daytime35465.12,03212.2338270.22,45414.75
 Nocturnal11621.31951.1713625.02951.77
 Total49591.09,03354.3750091.910,00660.14
Meal-related severe or BG confirmed
 Within 1 h after a meal5710.5740.455510.1650.39
 Within 2 h after a meal11621.32351.4112222.42471.48
 Within 4 h after a meal23242.67684.6226949.49745.85
  • Hypoglycemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the 1st day of exposure to randomized treatment and no later than 1 day after the last day of exposure to randomized treatment. Severe hypoglycemia was defined according to the American Diabetes Association classification (10), and BG-confirmed hypoglycemia was defined as an episode with a plasma glucose value <3.1 mmol/L (<56 mg/dL) with or without symptoms consistent with hypoglycemia. Nocturnal was defined as occurring in the period between 00:01 and 05:59 h (both included). Episodes with missing time stamps were considered daytime episodes. Total episodes included episodes where subjects were able to self-treat and that were not BG confirmed as well as episodes where subjects were able to self-treat but could not be classified due to missing data. %, percentage of participants; E, number of events; FA, fast-acting insulin aspart; n, number of participants; R, event rate per patient-year of exposure.