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news.Oramed Pharmaceuticals, a developer of oral delivery systems, has reported successful results from the Phase IIa clinical trial of its oral insulin capsule, ORMD 0801.
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The trial demonstrated that the product had a good safety profile and was well tolerated and effective in lowering blood glucose levels in patients with type 2 diabetes.
This trial was the first to expose patients with type 2 diabetes to ORMD 0801 and its primary goals were to assess the safety, tolerability and pharmcodynamic effects in these patients.
No serious adverse events were encountered throughout the study. In six of the nine subjects analyzed, statistically significant reductions in glucose as well as C-peptide were observed.
The study was conducted at Hadassah University Medical Center in Jerusalem and was a continuation of the successful Phase Ib trials that Oramed completed earlier this year.
Miriam Kidron, chief scientist of Oramed, said: “We are pleased with the results from the Phase IIa trial as they showed that ORMD 0801 was effective and there were no safety issues. We look forward to our next Phase of testing and taking the next steps towards making an oral insulin capsule a reality for millions of diabetics around the world.”