drugset / Trial / NCT04817215
Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
Phase 3
Unknown
608 enrolled
King Hamad University Hospital, Bahrain
Oramed, Ltd. · collabRoyal College of Surgeons in Ireland - Medical University of Bahrain · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-10
- Primary completion
- 2022-04
- Completion
- 2022-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ORMD-0801 | Protein / enzyme biologic | 8 mg | — |