Adverse events.
dose-limiting, nausea, Nausea
DIABETIC KETOACIDOSIS
All AEs associated with the study drug were Grades 1 or 2. Patients in treatment groups receiving 200- and 400-mg suppositories reported a limited number of grade 1 AE’s related to the study medication which were not dose limiting. However, most participants enrolled in the 600 mg arm, reported Grade 1 AEs of nausea and one reported grade 2 nausea, which was controlled with ondansetron. Nausea was considered dose-limiting at the 600 mg dose. No SAEs associated with the study drug were reported by participants in any treatment group. One patient had a non-related SAE (diabetic ketoacidosis) due to non-compliance with insulin treatment.