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DEFEND-1 in early or newly diagnosed type 1 diabetes
2008-002205-40Phase 3Completed
- Sponsor
- Tolerx, Inc.
- Start
- Jul 2008
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in diabetes mellitus type 1 (T1D) comparing Otelixizumab with Placebo (2 arms). Primary endpoints: Change from baseline in 2-hour mixed meal stimulated C-peptide AUC at Month 12, Mixed meal-stimulated C-peptide AUC at Week 12 and Months 6, 18, and 24 and 1 more. Started Jul 2008; status: completed.
02
Drugs
otelixizumab
03
Conditions
diabetes mellitus type 1 (T1D)
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