Oramed completes patient enrollment in pivotal phase III oral insulin study ORA-D-013-1 of ORMD 0801 in type 2 diabetes.
Oramed Pharmaceuticals Inc. announced it has completed patient enrollment for its Phase III ORA-D-013-1 study of its oral insulin capsule ORMD 0801 for the treatment of type 2 diabetes (T2D), surpassing its target of 675 patients with 710 patients enrolled.
ORA-D-013-1 is the larger of Oramed’s two Phase III studies being conducted under FDA approved protocols to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months. Efficacy data for ORA-D-013-1 will become available after all patients have completed the first 6-month treatment period.
About the Study: The ORA-D-013-1 study initially aimed to enroll 675 patients and has now completed its enrollment oversubscribed with a total of 710 patients. The enrolled patients are currently on 2 or 3 oral glucose-lowering agents through 96 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.
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