At a glance
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Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes - DEFEND
In Brief
A Phase 3 clinical trial evaluating otelixizumab infusion plus physician determined standard of care and placebo infusion plus physician determined standard of care for Diabetes Mellitus, Type 1. Completed, enrolled 272 participants across 109 sites in 9 countries.
Detailed 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
Study Details
Timeline
Interventions
infusion
infusion