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NCT02954601 · ClinicalTrials.gov registry record · Phase 2
A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study, sponsored by Oramed.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT02954601 is a Phase 2 study that has completed, run by Oramed. The registered enrollment target is 31 participants.
The verdict
NCT02954601, a Phase 2 study, has completed, sponsored by Oramed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a four-way crossover (non-parallel) study with each subject receiving three of the four arms. The study will enroll approximately 30 adult subjects with T2DM from age 20 to 75 inclusive. Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will include three treatment assignments for each of three treatment Periods according to the randomization scheme.
Interventions
- OTHER Placebo
- DRUG ORMD-0801 (qd)
- DRUG ORMD-0801 (bid)
- DRUG ORMD-0801 (tid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2016-10 |
| Est. Completion | 2017-03-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02954601
The ClinicalTrials.gov registry entry for NCT02954601 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 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 4 interventions - of which Placebo is the first listed.
NCT02954601 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02954601 about?
NCT02954601 is a clinical study titled "A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus". This is a four-way crossover (non-parallel) study with each subject receiving three of the four arms. The study will enroll approximately 30 adult subjects with T2DM from age 20 to 75 inclusive. Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind placebo run-in....
What is the current status of trial NCT02954601?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2016-10. Estimated completion is 2017-03-15.
What interventions are being tested in trial NCT02954601?
The interventions under investigation include: Placebo (OTHER), ORMD-0801 (qd) (DRUG), ORMD-0801 (bid) (DRUG), ORMD-0801 (tid) (DRUG).
Who is sponsoring clinical trial NCT02954601?
This trial is sponsored by Oramed, which has 11 total clinical trials registered on ClinicalTrials.gov.
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