Table 4.
Hypoglycemia
| IDeg (n = 174) |
IDet (n = 175) |
|||||||
|---|---|---|---|---|---|---|---|---|
| n | % | E | R | n | % | E | R | |
| All confirmed hypoglycemia | 171 | 98.3 | 9317 | 5771 | 168 | 96.0 | 7967 | 5405 |
| Nocturnal confirmed hypoglycemia | 133 | 76.4 | 973 | 603 | 125 | 71.4 | 1120 | 760 |
| All reported severe hypoglycemia | 31 | 17.8 | 82 | 51 | 24 | 13.7 | 48 | 33 |
| Externally classified severe episodes | 28 | 16.1 | 61 | 38 | 22 | 12.6 | 38 | 26 |
| Altered mental status and cannot assist in own care | 21 | 12.1 | 46 | 28 | 11 | 6.3 | 18 | 12 |
| Semiconscious or unconscious | 7 | 4.0 | 7 | 4 | 6 | 3.4 | 10 | 7 |
| Coma ± convulsions | 6 | 3.4 | 8 | 5 | 7 | 4.0 | 10 | 7 |
| Not severe hypoglycemia | 5 | 2.9 | 13 | 8 | 5 | 2.9 | 8 | 5 |
| Not possible to classify | 5 | 2.9 | 8 | 5 | 1 | 0.6 | 2 | 1 |
E, number of events; IDeg, Insulin degludec; IDet, insulin detemir; n, number of participants; %, percentage of participants; R, event rate per 100 patient-years of exposure; SAS, safety analysis set.