A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes
Status:
Unknown status
Trial end date:
2020-03-01
Target enrollment:
Participant gender:
Summary
This study is a Phase 2 randomized, crossover study comparing ORMD-0801 given QD versus TID
in subjects with T1D. Subjects with T1D will have a screening visit (Visit 1) during which
they will be required to review and sign the informed consent form. Medical history and
demographics will be collected. Vital signs will be measured, physical exam will be
performed, and blood and urine samples will be collected for hematology/chemistry/urinalysis
Placebo capsules will be given QD at bedtime during placebo run-in period 10 days prior to
randomization.