TABLE 3.
Summary of Hypoglycemia Data
| IDeg U200 (n = 140) |
IGlar U100 (n = 142) |
IDeg U200 Versus IGlar U100 |
||||
|---|---|---|---|---|---|---|
| Incidence(% [n]) | Episodes/PYE (n) | Incidence(% [n]) | Episodes/PYE (n) | Rate Ratio | 95% CI | |
| Severe | 2.9 (4) | 0.12 | 0.7 (1) | 0.02 | 5.12 | 0.492–53.14 |
| Confirmed | 26.4 (37) | 1.92 | 36.6 (52) | 2.88 | 0.59* | 0.391–0.901 |
| Nocturnal confirmed | 9.3 (13) | 0.38 | 11.3 (16) | 0.63 | 0.66 | 0.290–1.480 |
*
P <0.05, safety analysis set. None of the severe hypoglycemic episodes led to withdrawal or were linked to other AEs. Only one severe hypoglycemic episode was reported as serious; it occurred during the follow-up period (3 days after last drug date [IDeg]). According to the patient’s wife, the patient had not eaten that day. The patient was treated orally with orange juice by his wife and recovered on the same day. PYE, patient-year of exposure.