Phase II study of ORMD 0801 (Oramed Pharmaceuticals) successful for Type 1 Diabetes treatment
Oramed Pharmaceutical's clinical studies assessing the safety and efficacy of ORMD 0801 (oral insulin) in patients with Type 1 Diabetes (T1DM) show that the drug was safe and well tolerated. A study in a subpopulation of T1DM patients who experience frequent and unpredictable swings in their blood sugar levels, shows that the drug effectively kept blood sugar levels in check, when administered before meals.
In addition, the blood sugar readings of unstable T1DM patients more frequently fell within the normal range, when compared to those of the pretreatment monitoring sessions. The results also demonstrate that ORMD 0801 effectively delivers insulin without compromising its bioactivity. Results were presented at the Global Technology Community Diabetes Summit 2013.
ORMD 0801 is currently approaching Phase II clinical trials under an Investigational New Drug application with the FDA, and with its oral exenatide capsule ORMD 0901 is approaching Phase IIa trials.
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