Table 3.

Adverse events

	ELEMENT 5 total population		India subpopulation		East Asia subpopulation
	LY IGlar N = 249	IGlar N = 244	LY IGlar N = 49	IGlar N = 51	LY IGLar N = 67	IGlar N = 67
TEAE	110 (44.2)	123 (50.4)	14 (28.6)	15 (29.4)	22 (32.8)	32 (47.8)
Discontinuation due to AE	1 (0.4)	1 (0.4)	1 (2.0)	0 (0.0)	0 (0.0)	1 (1.5)
TEAE possibly related to study drug	24 (9.6)	18 (7.4)	6 (12.2)	3 (5.9)	3 (4.5)	2 (3.0)
TEAE possibly related to study procedure	2 (0.8)	5 (2.0)	1 (2.0)	1 (2.0)	0 (0.0)	2 (3.0)
Injection site AE	6 (2.4)	9 (3.7)	1 (2.0)	1 (2.0)	3 (4.5)	3 (4.5)
TEAE with special topic assessment of allergic events	10 (4.0)	15 (6.1)	2 (4.1)	4 (7.8)	3 (4.5)	1 (1.5)
SAE	10 (4.0)	12 (4.9)	0 (0.0)	0 (0.0)	3 (4.5)	3 (4.5)
Deaths	0 (0.0)	1 (0.4)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)

Values are presented as number of patients with ≥ 1 event or number of patients (%)

p > 0.05 for all comparisons between LY IGlar and IGlar in all three populations

AE adverse events, IGlar insulin glargine (Lantus), LY IGlar Lilly insulin glargine, SAE serious adverse event, TEAE treatment-emergent adverse event