The unpredictable behavior of uncontrolled type 1 diabetes often involves 
frequent swings in blood glucose levels that impact maintenance of a daily 
routine. An intensified insulin regimen is often unsuccessful, while other 
therapeutic options, such as amylin analog injections, use of continuous glucose 
sensors, and islet or pancreas transplantation are of limited clinical use. In 
efforts to provide patients with a more compliable treatment method, Oramed 
Pharmaceuticals tested the capacity of its oral insulin capsule (ORMD-0801, 8 mg 
insulin) in addressing this resistant clinical state. Eight Type I diabetes 
patients with uncontrolled diabetes (HbA1c: 7.5-10%) were monitored throughout 
the 15-day study period by means of a blind continuous glucose monitoring 
device. Baseline patient blood glucose behavior was monitored and recorded over 
a five-day pretreatment screening period. During the ensuing ten-day treatment 
phase, patients were asked to conduct themselves as usual and to self-administer 
an oral insulin capsule three times daily, just prior to meal intake. CGM data 
sufficient for pharmacodynamics analyses were obtained from 6 of the 8 subjects. 
Treatment with ORMD-0801 was associated with a significant 24.4% reduction in 
the frequencies of glucose readings >200 mg/dL (60.1 ± 7.9% pretreatment vs. 
45.4 ± 4.9% during ORMD-0801 treatment; p = 0.023) and a significant mean 16.6% 
decrease in glucose area under the curve (AUC) (66055 ± 5547 mg/dL/24 hours vs. 
55060 ± 3068 mg/dL/24 hours, p = 0.023), with a greater decrease during the 
early evening hours. In conclusion, ORMD-0801 oral insulin capsules in 
conjunction with subcutaneous insulin injections, well tolerated and effectively 
reduced glycemia throughout the day.
TRIAL REGISTRATION: Clinicaltrials.gov NCT00867594.