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NCT02496000 · ClinicalTrials.gov registry record · Phase 2
Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study of Diabetes Type 2, sponsored by Oramed.
- Completed
- Registry status
- Phase 2
- Development phase
- 188
- Enrollment target
- 20
- Study locations
NCT02496000: Completed Phase 2 study of Diabetes Type 2, sponsored by Oramed.
NCT02496000 is a Phase 2 study of Diabetes Type 2 that has completed, run by Oramed. The registered enrollment target is 188 participants, below the 660-participant average among 24 other Diabetes Type 2 trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02496000, a Phase 2 study of Diabetes Type 2, has completed, sponsored by Oramed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 188 participants
- Enrollment target
- 20
- Study locations
Study Summary
Randomized, double-blind, placebo-controlled, parallel group study.
Primary Outcome
The Effect of ORMD-0801 (Doses 1 \& 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at
Conditions Studied
Interventions
- DRUG Placebo Comparator
- DRUG ORMD-0801
Study Locations (20)
Florida
- Meridien Research - Bradenton
- Meridien Research - Brooksville
- Clinical Research of West Florida, Inc. - Clearwater
- Research in Miami Inc. - Hialeah
- Research in Miami, Inc. - Hialeah
- Phoenix Medical Research LLC - Miami
- Ormond Medical Arts Pharmaceutical Research Center - Ormond Beach
- Clinical Research of West Florida, Inc. - Tampa
- Meridien Research - Tampa
- Metabolic Research Institute, Inc - West Palm Beach
California
- Dream Team Clinical Research - Anaheim
- ACTCA, Inc. - Los Angeles
- ACTCA - Los Angeles
- National Research Institute - Los Angeles
- Providence Clinical Research - North Hollywood
- Mills-Peninsula Health Services - San Mateo
- Orange County Research Center - Tustin
Arizona
- Steingard Medical Group - Phoenix
Arkansas
- Arkansas Primary Care Clinic, PA - Little Rock
Colorado
- Creekside Endocrine Associates, PC - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2015-07-27 |
| Est. Completion | 2016-09-13 |
| Phase | Phase 2 |
What the finished NCT02496000 record still lists
NCT02496000 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 660-participant average among 24 other Diabetes Type 2 trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Diabetes Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT02496000 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02496000 about?
NCT02496000 is a clinical study titled "Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus". Randomized, double-blind, placebo-controlled, parallel group study.
What is the current status of trial NCT02496000?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 188 participants. The study started on 2015-07-27. Estimated completion is 2016-09-13.
What conditions does trial NCT02496000 study?
This clinical trial studies the following conditions: Diabetes Type 2.
What interventions are being tested in trial NCT02496000?
The interventions under investigation include: Placebo Comparator (DRUG), ORMD-0801 (DRUG).
Who is sponsoring clinical trial NCT02496000?
This trial is sponsored by Oramed, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02496000 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02496000's enrollment target sits among peer trials
188 12th of 24 higher than 13 of 24 other Diabetes Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Type 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.
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