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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 is a Phase 2 study that has completed, run by Oramed. The registered enrollment target is 25 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02094534
The ClinicalTrials.gov registry entry for NCT02094534 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 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 2 interventions - of which Placebo is the first listed.
NCT02094534 reports 0 study locations.
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.
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