At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Open Label Crossover Study to Compare ORMD-0801 Given Once Daily at Bedtime to ORMD-0801 Given Three Times Daily (45-90 Minutes Before Meals) in Subjects With Type 1 Diabetes
In Brief
A Phase 2 clinical trial evaluating ORMD-0801 Treatment A, ORMD-0801 Treatment B, and 1 other intervention for Type 1 Diabetes. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Treatment A: 24 mg (16 mg capsule + 8 mg capsule) Once Daily (QD) at bedtime
Treatment B: 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals
Fish oil capsule