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NCT03467932 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus
A Phase 2 study, sponsored by Oramed.
- Completed
- Registry status
- Phase 2
- Development phase
- 373
- Enrollment target
NCT03467932: Completed Phase 2 study, sponsored by Oramed.
NCT03467932 is a Phase 2 study that has completed, run by Oramed. The registered enrollment target is 373 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (180% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03467932, a Phase 2 study, has completed, sponsored by Oramed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 373 participants
- Enrollment target
Study Summary
This is a four-way (Participant, Care Provider, Investigator, Outcomes Assessor) masked (blinded) study designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM).
Primary Outcome
Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C.
Interventions
- DRUG Placebo oral capsule
- DRUG Cohort A: ORMD-0801
- DRUG Cohort B: ORMD-0801
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2020-02-18 |
| Phase | Phase 2 |
What the finished NCT03467932 record still lists
NCT03467932 is an interventional study that assigns participants to a tested intervention. The registered 373 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (180% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT03467932 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03467932 about?
NCT03467932 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus". This is a four-way (Participant, Care Provider, Investigator, Outcomes Assessor) masked (blinded) study designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM).
What is the current status of trial NCT03467932?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 373 participants. The study started on 2018-05-29. Estimated completion is 2020-02-18.
What interventions are being tested in trial NCT03467932?
The interventions under investigation include: Placebo oral capsule (DRUG), Cohort A: ORMD-0801 (DRUG), Cohort B: ORMD-0801 (DRUG).
Who is sponsoring clinical trial NCT03467932?
This trial is sponsored by Oramed, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03467932's enrollment target sits among peer trials
373 118th of 2000 higher than 1,883 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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