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NCT00678886 · ClinicalTrials.gov registry record · Phase 3
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 272
- Enrollment target
NCT00678886 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 272 participants.
The verdict
NCT00678886, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 272 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo infusion. Insulin secretion will be assessed using mixed meal-stimulated C-peptide. Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other physician determined standard of care treatments. DEFEND-1 is now closed to enrollment. DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require subjects with new onset type 1 diabetes. Please check back here for more details. In the meantime, established and new onset type 1 diabetes patients in North America are welcome to consider the TTEDD study: http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD\&rank=1
Interventions
- BIOLOGICAL otelixizumab infusion plus physician determined standard of care
- BIOLOGICAL placebo infusion plus physician determined standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2008-07-29 |
| Est. Completion | 2012-01-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00678886
The ClinicalTrials.gov registry entry for NCT00678886 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which otelixizumab infusion plus physician determined standard of care is the first listed.
NCT00678886 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00678886 about?
NCT00678886 is a clinical study titled "Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1". The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo infusion. Insulin secretion will be assessed using mixed meal-stimulated C-peptide. Subjects will be assigned to receive either otelixizum...
What is the current status of trial NCT00678886?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 272 participants. The study started on 2008-07-29. Estimated completion is 2012-01-31.
What interventions are being tested in trial NCT00678886?
The interventions under investigation include: otelixizumab infusion plus physician determined standard of care (BIOLOGICAL), placebo infusion plus physician determined standard of care (BIOLOGICAL).
Who is sponsoring clinical trial NCT00678886?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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