Trial Information

Summary: The DEFEND-1 Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 (Autoimmune) Diabetes Mellitus

Purpose - 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.

Inclusion criteria:

• Ages 18 - 35
• Diagnosis of type 1 (autoimmune) diabetes mellitus, consistent with ADA criteria
• No more than 90 days between diagnosis and administration of study compounds
• Must be on insulin therapy
• Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50 nmol/L
• Positive for one or both of the following antibodies: islet-cell autoantibodies (anti-IA2) and/or glutamic acid decarboxylase (GAD) autoantibodies

Exclusion criteria:

• Other, significant medical conditions based on the study doctor’s evaluation

If you would like to learn more about participating in this study, please send an e-mail message using the form below.