Table 2.
Episodes of hypoglycaemia occurring on or after the first day of exposure to treatment and no later than 7 days after the last day of treatment (SAS)
| IDeg + IAsp (n = 124) | IDet + IAsp (n = 61) | ETR (95 % CI)a | |||||
|---|---|---|---|---|---|---|---|
| n (%) | E | Rate/PYE | n (%) | E | Rate/PYE | ||
| Overall confirmed hypoglycaemia | 122 (98.4) | 3666 | 59.9 | 60 (98.4) | 1759 | 59.2 | 0.94 (0.70, 1.25) |
| Nocturnal confirmed hypoglycaemia | 74 (59.7) | 318 | 5.2 | 44 (72.1) | 281 | 9.5 | 0.48 (0.31, 0.75) |
| Severe hypoglycaemia | 8 (6.5) | 9 | 0.15 | 0 | 0 | 0 | b |
| Nocturnal severe hypoglycaemia | 1 (0.8) | 1 | 0.02 | 0 (0.0) | 0 | 0 | b |
| Daytime confirmed hypoglycaemia | 122 (98.4) | 3347 | 54.7 | 58 (95.1) | 1470 | 49.4 | 1.03 (0.77, 1.37) |
| Daytime severe hypoglycaemia | 6 (4.8) | 7 | 0.11 | 0 (0.0) | 0 | 0 | b |
Severe hypoglycaemia (according to the ADA definition): an episode requiring the assistance of another person to actively administer carbohydrates, glucagons or other resuscitative actions
Daytime period: the period between 06:00 and 00:00 (both included)
Nocturnal period: the period between 00:01 and 05:59 (both included)
ADA American Diabetes Association, CI confidence interval, E number of events, ETR estimated treatment ratio of IDeg + IAsp: IDet + IAsp, IAsp insulin aspart, IDeg insulin degludec, IDet insulin detemir, n number of subjects, PYE patient-years of exposure, SAS safety analysis set, % percentage of all randomised participants in treatment group
aFull analysis set
bStatistical analysis was not done due to there being only a few events in the IDeg + IAsp group and no events in the IDet + IAsp group
Confirmed hypoglycaemia was defined as plasma glucose <3.1 mmol/L (56 mg/dL), regardless of symptoms, or severe episodes (requiring assistance from another person)