At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes
In Brief
A Phase 3 clinical trial evaluating Otelixizumab and Placebo for Diabetes Mellitus, Type 1. Completed, enrolled 179 participants across 1 site.
Detailed Summary
DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo. 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 standard of care treatments.
Study Details
Timeline
Interventions
infusion
Infusion