Table 4.

Safety and tolerability (safety set).

	Vildagliptin (n = 60)		Liraglutide (n = 62)
	Number of AEs	Number (%) of patients	Number of AEs	Number (%) of patients
All AEs	16	9 (15.0)	46	23 (37.1)
All SAEs	0	0	2	2 (3.2)
Severe AEs	0	0	1	1 (1.6)
Common AEs by primary SOC (occurring in ⩾2% of patients in any treatment group)
Gastrointestinal disorders	2	2 (3.3)	20	15 (24.2)
Infections and infestations	2	2 (3.3)	5	4 (6.5)
Metabolism and nutrition disorders	1	1 (1.7)	9	5 (8.1)
Nervous system disorders	2	2 (3.3)	5	4 (6.5)
Musculoskeletal and connective tissue disorders	2	2 (3.3)	2	2 (3.2)
Cardiac disorders	1	1 (1.7)	2	2 (3.2)
Skin and subcutaneous tissue disorders	2	2 (3.3)	0	0

The columns vildagliptin and liraglutide refer to the last treatment received before the onset of an AE.

Safety set consisted of all patients who received at least one dose of the study medication during at least one study period and had at least one safety assessment after baseline.

AE, adverse event; SAE, serious adverse event; SOC, system organ class.