Oramed Pharmaceuticals (NSDQ:ORMP) announced that it reached 25% randomization in the enrollment for its oral insulin capsule trial.
New York-based Oramed’s Phase 3 ORA-D-013-1 study for the ORMD-0801 oral insulin capsule for the treatment of Type 2 diabetes has planned for 675 patients overall, reaching a quarter of that mark in enrollment so far with a pace set to have topline results in 2022.
“We are very pleased with the pace of patient enrollment in this ORA-D-013-1 study, which keeps us on track to complete randomization of all 675 patients by the end of 2021, as we look ahead to topline results next year,” Oramed CEO Nadav Kidron said in a news release.
ORA-D-013-1 is one of two concurrent Phase 3 studies under FDA-approved protocols for treating Type 2 diabetes patients who have inadequate glycemic control over a period of six to 12 months.
The trial, which is double-blinded, placebo-controlled and multi-centered, is set to evaluate the efficacy and safety of Oramed’s oral insulin capsule, with efficacy data set to be made available after all patients complete the first six-month treatment period.
Oramed said the primary endpoint for the study is to compare the efficacy of ORMD-0801 to placebo in approving glycemic control as assessed by A1c, while the secondary endpoint is assessing the change in baseline in fasting plasma glucose at 26 weeks.