Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
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.
Following the screening, eligible subjects entered a 3-day, single-blind placebo run-in. On
Day 4, each subject was randomized to a treatment sequence that included three treatment
assignments for each of three treatment Periods according to the randomization scheme.
Pre-assignment Details The number of participants receiving each Intervention, in each
Period, is reported.
Subjects received the randomized treatment from Day 4 through Day 8. There was a 24-hour
single-blind placebo washout on Day 9. Each subject received placebo for one of the three
treatment periods. Each subject also received 1 of the 3 active doses randomly in each of the
two other treatment periods respectively. The dosing order is random.
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