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news.Oramed Pharmaceuticals (Oramed) has completed patient enrollment in the phase 2B clinical study of its oral insulin capsule, ORMD-0801. The last of the thirty type II diabetes patients was enrolled for a study, in which subjects are expected to be administered the insulin-based capsule for a period of six weeks.
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Reportedly, the randomised, double-blind, placebo-controlled, multi-centered study is expected to evaluate the safety, tolerability, and efficacy of Oramed’s oral insulin delivery technology. The company is conducting the study in five locations throughout South Africa and is being monitored by OnQ Consulting. Study results are expected by the end of Q1, 2010.
The company said that the trial marks an important milestone in ORMD-0801 safety testing, assessing the first indication of ORMD-0801 on a large group of volunteers over an extended treatment period.
Nadav Kidron, CEO of Oramed, said: “The closing of enrollment for the Phase 2B trial is an exciting accomplishment for us, as it moves us closer to completing this trial and receiving the results. In the upcoming months, we look forward to being able to share the results from the trial, which will mark a major milestone in the development of oral insulin.”