Comparative Assessment of the Glucose-Lowering Effect of Multiple Oral Insulin (ORMD-0801) Formulation Variants in Pigs
6/15/2014 5:00:00 AM
6/15/2014 6:00:00 AM
, EHUD ARBIT, YAEL SHUSHLAV,
Oral drug delivery platforms are being actively pursued to provide an oral insulin solution to diabetes patients. ORMD-0801, designed using the POD
technology, has established the indispensability of antiproteolytic support and absorption enhancing factors toward effective passage of orally delivered insulin through the gastrointestinal tract to its site of action. ORMD-0801 has elicited improved glycemic control in type 1 and type 2 diabetes patients and is currently being assessed in large-scale clinical trials. In efforts to further enhance formulation stability and bioperformance, a comparative analysis of the glucose-lowering effects of two surfactant combinations (herein, EC-TA and SW-G), added to the basic oral insulin (ORMD-0801) formulation, was performed following their administration to healthy, fasting pigs (n=3-4). At each session, a single dose of an ORMD-0801 formulation variant, was directly administered to the duodenum, under endoscopic guidance, and blood glucose levels were monitored for the ensuing 150 minutes. All tested formulations, including the surfactant-free variant, induced a significant glucose-lowering effect within 30 min of administration, with C
obtained within 30-90 min of dosing. All but the SW-G formulations led to glucose lows which plateaued for 45-60 min before beginning to return to baseline levels. The overall effect of EC-TA-supplemented formulations on mean blood glucose concentrations, was significantly greater than those supplemented with SW-G, for all tested doses (p<0.04). The glucose area under the curve of mean EC-TA-elicited responses was 34% lower than that obtained with the SW-G-supplemented formulation and the surfactant-free formulation. This study demonstrated the primacy of the EC-TA surfactant combination in the tested oral insulin formulation; further studies will be required to evaluate its translation in the clinic.
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