The number of patients meeting the definition of Hy's Rule (i.e., an ALT and/or AST measurement > 3xULN and a bilirubin > 2xULN) at any time during the study was 2 in the sitagliptin group (with both cases resolving while continuing treatment; 1 patient had suspected concurrent bacteremia and a history of steatohepatitis, and the other had elevated ALT/AST and alkaline phosphatase prior to randomization) and 1 in the non-exposed group (in a patient with concurrent diagnosis of a liver abscess). Here, GPT is linked to bacterial infectious disease with sepsis.