Oramed Pharmaceuticals announced 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.

"We're excited to be the first company in the world to conduct an FDA approved Phase 3 study for oral insulin," said Oramed CEO Nadav Kidron. "This is an important study and we're pleased that recruitment for the study is proceeding as planned. We look forward to sharing more updates as we progress."

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.