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

The following visits are required:

- Screening Visits: 2 to 3 appointments will be conducted to determine eligibility. At 2
of these visits participants will drink a liquid meal and have blood tests done over the
post-meal period.

- Dosing Visits: 8 outpatient visits on consecutive days, each lasting about 4-6 hours.

- Follow-up Visits: weekly for the first month, then every 2 weeks for 3 months, followed
by monthly visits through 1 year. There will be 3 visits in the second year.

- The total duration of the study is 2 years.

- Glucose test strips, glucose monitors and PDAs to record insulin will be provided to all
study subjects for the duration fo the study. Frequent glycemic monitoring will occur
through lab testing and blood glucose self-monitoring to help facilitate tight glycemic
control in all subjects.

Inclusion Criteria:

- Ages 12-45

- Diagnosis of diabetes mellitus, consistent with ADA criteria

- No more than 90 days between diagnosis and administration of study compounds

- Requires insulin for type 1 diabetes mellitus, or has required insulin at some time
between diagnosis and administration of study compounds.

- Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50
nmol/L

- Positive for one or more of the autoantibodies typically associated with T1DM:
antibody to glutamic acid decarboxylase (anti‑GAD); antibody to protein tyrosine
phosphatase-like protein (anti‑IA‑2); zinc transporter autoantibodies (ZNT8); insulin
autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and
negative for the other autoantibodies will only be eligible if the subject has used
insulin for less than 7 days total.

Exclusion Criteria:

- Other, significant medical conditions based on the study doctor's evaluation