Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
Status:
Not yet recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by
A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and
metformin monotherapy or two or three oral glucose-lowering agents.
To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM
subjects on on diet control alone or on diet control and metformin monotherapy or two or
three oral glucose-lowering agents.
Phase:
Phase 3
Details
Lead Sponsor:
King Hamad University Hospital, Bahrain
Collaborators:
Oramed, Ltd. Royal College of Surgeons in Ireland - Medical University of Bahrain