Table 5.

Listing of treatment-emergent adverse events observed during the study

Adverse events Primary system organ class  Preferred term, number of participantsa (%)	Gla-300 (N = 20)b	Gla-100 (N = 20)b
Any class	9 (45.0)	4 (20.0)
Infections and infestations	2 (10.0)	2 (10.0)
Nasopharyngitis	2 (10.0)	2 (10.0)
Nervous system disorders	2 (10.0)	0 (0.0)
Dizziness postural	1 (5.0)	0 (0.0)
Headache	1 (5.0)	0 (0.0)
Gastrointestinal disorders	3 (15.0)	0 (0.0)
Abdominal discomfort	1 (5.0)	0 (0.0)
Dental caries	1 (5.0)	0 (0.0)
Stomatitis	1 (5.0)	0 (0.0)
Vomiting	1 (5.0)	0 (0.0)
Skin and subcutaneous tissue disorders	0 (0.0)	1 (5.0)
Pruritus	0 (0.0)	1 (5.0)
Rash	0 (0.0)	1 (5.0)
Musculoskeletal and connective tissue disorders	2 (10.0)	0 (0.0)
Plantar fasciitis	1 (5.0)	0 (0.0)
Tenosynovitis	1 (5.0)	0 (0.0)
Reproductive system and breast disorders	1 (5.0)	0 (0.0)
Menstruation irregular	1 (5.0)	0 (0.0)
Injury, poisoning and procedural complications	1 (5.0)	1 (5.0)
Intentional overdose	0 (0.0)	1 (5.0)
Accidental overdose	1 (5.0)	0 (0.0)

Gla-300 insulin glargine 300 U mL⁻¹, Gla-100 insulin glargine 100 U mL⁻¹

^aSome participants experienced more than one adverse event

^bData pooled from subgroups 1 and 2 by treatment