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Emisphere to begin phase-2 clinical trial for oral insulin
By Angela McDaniels
Seattle, Nov. 3 - Emisphere Technologies Inc. said it has received permission from
the U.S. Food and Drug Administration and regulatory authorities in India to begin a phase-2 trial for its oral insulin product.
Emisphere said it plans to initiate patient enrollment later this month for the study, which will evaluate the safety and efficacy of low and high doses of oral insulin tablets versus placebo in 120 subjects with type-2 diabetes.
"India has a large diabetic patient population and provides Emisphere, with the help of its locally based contract research organizations, the opportunity to rapidly enroll patients in a cost-effective manner," said Michael M. Goldberg, chairman and chief executive officer of Emisphere, in a news release.
Emisphere is a biopharmaceutical company based in Tarrytown, N.Y., that develops oral formulations for injectable drugs.
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