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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: Completed Phase 2 study, sponsored by Oramed.
NCT02954601 is a Phase 2 study that has completed, run by Oramed. The registered enrollment target is 31 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
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.
Primary Outcome
Measure the change in Glucose (mg/dL) by 24 hour CGM between Day3 and Day8 (Change in mg/dL between run-in and Day 5 of Active treatment)
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 |
What the finished NCT02954601 record still lists
NCT02954601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 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 4 interventions - of which Placebo is the first listed.
NCT02954601 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02954601's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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