The poster presentation entitled "Extended exposure to an oral insulin
formulation yields decreased insulin secretion in Type II diabetes subjects,"
described Oramed's first extended exposure study to its oral insulin product
(ORMD-0801), where 21 patients were treated with ORMD-0801, self-administered
daily for a period of six weeks. In parallel, a group of eight patients
received placebo capsules administered under the same treatment regimen.
ORMD-0801 proved safe and tolerable, with no reports of serious adverse
events throughout the study. In addition, no cumulative effects of extended
ORMD-0801 exposure were noted, and only two mild cases of transient
hypoglycemia were reported. Treatment efficacy was evaluated via markers
quantified from blood samples drawn at the start and end of the study. Daily
administration of oral insulin led to a statistically significant decrease in
both insulin and C-reactive protein (CRP) levels, in contrast to their
elevation among placebo-treated individuals. Moreover, the percentage of
subjects demonstrating clinically relevant reductions in insulin, c-peptide,
fasting blood glucose (FBG) and Hb1Ac levels was consistently higher in the
ORMD-0801 cohort, when compared to its placebo counterpart. This study
addressing, for the first time, potential long-term safety concerns from
extended ORMD-0801 administrations, demonstrated safety and no seri
|SOURCE Oramed Pharmaceuticals Inc.|
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