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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

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

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× ULNa 16 (0.7) 17 (0.8)
Mean change from baseline (SD) at Week 54b (IU/L)
 ALT −0.6 (15.2) −0.6 (12.5)
 AST 0.2 (14.5) −0.4 (9.7)
  1. 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)
  2. aIncluding supplemental laboratory data
  3. bMean changes based on n = 1801 in the omarigliptin group and n = 1756 in the placebo group