Table 2.

Frequency and analysis of hypoglycemic episodes (safety and full analysis sets)

	IDeg OD (n = 553)			IGlar OD (n = 278)			Estimated rate ratio IDeg/IGlar [95 % CI]
	Subjects n (%)	Episodes	Ratea	Subjects n (%)	Episodes	Ratea
Overall severeb	2 (0.4)	2	1	2 (0.7)	2	1	ND
Overall confirmedc	128 (23.1)	228	85	79 (28.4)	130	97	0.80 [0.59 to 1.10]
Nocturnal confirmedc,d	40 (7.2)	58	22	25 (9.0)	32	24	0.77 [0.43 to 1.37]

Summary statistics for the safety analysis set and statistical analysis on the full analysis set

The estimated rate ratio was analyzed in a negative binomial regression model including treatment, antidiabetic therapy at screening, sex and region as fixed factors, age as covariate, and log exposure as offset. Statistical analysis of severe hypoglycemic episodes was not performed because of too few episodes

IDeg insulin degludec, IGlar insulin glargine, OD once daily, CI confidence interval, ND not done

^aNumber of hypoglycemic episodes per 100 patient-years of exposure

^bRequiring assistance of another person to actively administer carbohydrate, glucagons, or other resuscitative actions

^cIncludes episodes of severe hypoglycemia as well as hypoglycemic episodes with confirmed plasma glucose <3.1 mmol/L

^dTime of onset between 00:01 and 05:59 (both inclusive)