12.01.2023 02:30:49
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Oramed To Stop Oral Insulin Clinical Activities For Type 2 Diabetes Following Disappointing Results
(RTTNews) - Oramed Pharmaceuticals Inc. (ORMP) expects to discontinue its oral insulin clinical activities for Type 2 Diabetes, following disappointing clinical trial results with ORMD-0801.
The company said its phase 3 clinical trial (ORA-D-013-1) did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks.
The trial also did not meet its secondary endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks.
There were no serious drug-related adverse events.
ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control on two or three oral glucose-lowering agents.
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