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NCT04606576 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by Oramed.
- Terminated
- Registry status
- Phase 3
- Development phase
- 710
- Enrollment target
NCT04606576 is a Phase 3 study that was terminated before completion, run by Oramed. The registered enrollment target is 710 participants.
The verdict
NCT04606576, a Phase 3 study, was terminated before completion, sponsored by Oramed.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 710 participants
- Enrollment target
Study Summary
In this randomized, double-blind, double-dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a 26-week Double-Blind Treatment Extension Period.
Interventions
- OTHER Placebo
- DRUG ORMD-0801 QD
- DRUG ORMD-0801 BD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 710 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2023-01-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04606576
The ClinicalTrials.gov registry entry for NCT04606576 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 710 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oramed, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04606576 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04606576 about?
NCT04606576 is a clinical study titled "Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus". In this randomized, double-blind, double-dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treat...
What is the current status of trial NCT04606576?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 710 participants. The study started on 2020-12-15. Estimated completion is 2023-01-13.
What interventions are being tested in trial NCT04606576?
The interventions under investigation include: Placebo (OTHER), ORMD-0801 QD (DRUG), ORMD-0801 BD (DRUG).
Who is sponsoring clinical trial NCT04606576?
This trial is sponsored by Oramed, which has 11 total clinical trials registered on ClinicalTrials.gov.
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