Oramed Pharmaceuticals Inc (Nasdaq/TASE: ORMP), a clinical-stage pharmaceutical company, has screened the first patients in its global Phase three trials of its oral insulin capsule ORMD-0801 intended for the treatment of type two diabetes, it was reported on Tuesday.
The patients were screened at United States sites participating in the company's ORA-D-013-1 trial, one of two Phase three trials being conducted in accordance with United States Food and Drug Administration (FDA) approved protocols.
Both Phase 3 trials, ORA-D-013-1 and ORA-D-013-2 are intended to treat type 2 diabetes patients who have inadequate glycaemic control over a period of 6 to 12 months. The double-blinded, placebo-controlled, multi-centre randomised trials are to hire a total of 1,125 patients to evaluate the efficacy and safety of the product. Efficacy data will be revealed after all patients have completed the first six-month treatment period.
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