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Oral insulin capsule was safe, effective

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An oral insulin capsule for the treatment of type 2 diabetes lowered glucose levels and C peptide, according to the findings from a phase-2A trial.

The researchers from the Hadassah University Medical Center in Jerusalem conducted a study on the effect of an orally administered insulin capsule (ORMD 0801, Oramed Pharmaceuticals) on patients with type 2 diabetes.

“ORMD 0801 had a good safety profile, and it was well tolerated by 100% of the patients; no serious adverse events were encountered throughout the study,” Nadav Kidron, CEO of Oramed Pharmaceuticals, said during a telephone conference.

There was statistically significant response from 66% of the patients in the study, according to Kidron. “The capsule was absorbed through the gastrointestinal wall and achieved its biological effects by reducing blood glucose in patients with type 2 diabetes,” he said.

This trial was a continuation of a phase-1B trial conducted earlier this year, according to Kidron. Oramed will conduct more phase-2 trials, commencing by the first quarter 2009, and will meet with the FDA in about one year. – by Christen Haigh