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× 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) |
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