Safety
abnormal hepatic function, diarrhea, TEAEs, urticaria, TEAE
PANCREATITIS, URTICARIA
In all therapy groups, the occurrence of TEAE was typically modest and comparable. Most TEAEs were modest and were unrelated to study medications. Drug-related TEAEs with a greater incidence (> 2%) included diarrhea (9.7%, 2.4%, and 5.6% in IPE 2 g/day, 4 g/day and placebo, respectively). Serious TEAEs were recorded with a low incidence (2.4%, 3.2%, 2.4% in IPE 2 g/day, 4 g/day and placebo, respectively). There were no drug-related severe TEAEs. Due to TEAEs, three patients in the IPE 4 g/day group (2.4%; one patient each with abnormal hepatic function, urticaria, and severe pancreatitis) and one patient in the placebo group (0.8%; hypersensitive response) terminated the trial. Only two incidences of drug-related TEAEs resulting in the withdrawal of the research (one each in IPE 4 g/day was urticaria and in the placebo group was a hypersensitive response) was detected. Glucose and HbA1c responses were comparable across the IPE and placebo groups. Vital signs, electrocardiography, liver function tests, and serum creatinine phosphokinase levels were not statically significant after different IPE dosing treatments.