A randomized, placebo-controlled study of the cardiovascular safety of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus

Table 5 Incidences of adverse events related to alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and predefined limits of change for those liver tests in the APaT population, Treatment Period + 21 days; and change from baseline in ALT and AST at Week 54

Adverse event, n (%)	Omarigliptin N = 2092	Placebo N = 2100
ALT increased	24 (1.1)	16 (0.8)
AST increased	16 (0.8)	4 (0.2)
Predefined limit of change
ALT ≥3× ULN	35 (1.7)	34 (1.6)
AST ≥3× ULN	19 (0.9)	16 (0.8)
ALT ≥5× ULN	14 (0.7)	12 (0.6)
AST ≥5× ULN	10 (0.5)	6 (0.3)
ALT ≥5× ULN^a	16 (0.7)	17 (0.8)
Mean change from baseline (SD) at Week 54^b (IU/L)
ALT	−0.6 (15.2)	−0.6 (12.5)
AST	0.2 (14.5)	−0.4 (9.7)

Central laboratory normal range: ALT 10–40 IU/L (male) and 10–33 IU/L (female); AST 10–43 IU/L (male) and 10–36 IU/L (female)
^aIncluding supplemental laboratory data
^bMean changes based on n = 1801 in the omarigliptin group and n = 1756 in the placebo group

ISSN: 1475-2840