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NCT02094534 · ClinicalTrials.gov registry record · Phase 2
A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
A Phase 2 study, sponsored by Oramed.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT02094534: Completed Phase 2 study, sponsored by Oramed.
NCT02094534 is a Phase 2 study that has completed, run by Oramed. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02094534, a Phase 2 study, has completed, sponsored by Oramed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring (CGM) device. Patients will be given standardized meals and snacks for the duration of their inpatient visit.
Primary Outcome
Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.
Interventions
- OTHER Placebo
- BIOLOGICAL ORMD-0801 Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT02094534 record still lists
NCT02094534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02094534 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02094534 about?
NCT02094534 is a clinical study titled "A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics". This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no few...
What is the current status of trial NCT02094534?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2014-03. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02094534?
The interventions under investigation include: Placebo (OTHER), ORMD-0801 Capsules (BIOLOGICAL).
Who is sponsoring clinical trial NCT02094534?
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 NCT02094534's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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