Oramed Pharmaceuticals Inc. announced that randomization of patients in its first Phase 3 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D) is under way. The study is being conducted in accordance with U.S. Food and Drug Administration (FDA) approved protocols. ORA-D-013-1 is recruiting 675 patients who are currently on two or three oral glucose-lowering agents through 75 clinical sites throughout the U.S. The primary endpoint of the study is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c, with a secondary endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. Efficacy data will become available after all patients have completed the first 6-month treatment period. The ORA-D-013-1 trial is a double blind, double dummy study randomizing patients 1:1:1 for: 8 mg ORMD-0801 once-daily at night and placebo 45 minutes before breakfast; or 8 mg ORMD-0801 twice-daily at night and 45 minutes before breakfast; or placebo twice-daily at night and 45 minutes before breakfast.