At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study to Compare Safety, Efficacy, and Pharmacodynamics of Single and Multiple Doses of ORMD-0801 in Adult Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating ORMD-0801 (qd), ORMD-0801 (bid), and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 31 participants across 1 site.
Detailed Summary
This is a four-way crossover (non-parallel) study with each subject receiving three of the four arms. The study will enroll approximately 30 adult subjects with T2DM from age 20 to 75 inclusive. Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will include three treatment assignments for each of three treatment Periods according to the randomization scheme.
Study Details
Timeline
Interventions
Dose 1 = ORMD-0801 (qd)
Dose 2 = ORMD-0801 (bid)
Dose 3 = ORMD-0801 (tid)
fish oil placebo