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NCT04150107 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes
A Phase 2 study, sponsored by Oramed.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT04150107: Completed Phase 2 study, sponsored by Oramed.
NCT04150107 is a Phase 2 study that has completed, run by Oramed. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04150107, a Phase 2 study, has completed, sponsored by Oramed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is a Phase 2 randomized, crossover study comparing ORMD-0801 given QD versus TID in subjects with T1D. Subjects with T1D will have a screening visit (Visit 1) during which they will be required to review and sign the informed consent form. Medical history and demographics will be collected. Vital signs will be measured, physical exam will be performed, and blood and urine samples will be collected for hematology/chemistry/urinalysis Placebo capsules will be given QD at bedtime during placebo run-in period 10 days prior to randomization.
Primary Outcome
The least squares means difference of basal exogenous insulin between treatment A and placebo and treatment B and placebo, utilized over the final ten (10) days of each treatment period
Interventions
- OTHER Placebo
- DRUG ORMD-0801 Treatment A
- DRUG ORMD-0801 Treatment B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2020-03-12 |
| Phase | Phase 2 |
What the finished NCT04150107 record still lists
NCT04150107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04150107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04150107 about?
NCT04150107 is a clinical study titled "A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes". This study is a Phase 2 randomized, crossover study comparing ORMD-0801 given QD versus TID in subjects with T1D. Subjects with T1D will have a screening visit (Visit 1) during which they will be required to review and sign the informed consent form. Medical history and demographics will be collecte...
What is the current status of trial NCT04150107?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-10-17. Estimated completion is 2020-03-12.
What interventions are being tested in trial NCT04150107?
The interventions under investigation include: Placebo (OTHER), ORMD-0801 Treatment A (DRUG), ORMD-0801 Treatment B (DRUG).
Who is sponsoring clinical trial NCT04150107?
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 NCT04150107's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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