A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus

Inclusion Criteria:

- Adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks
of diagnosis), one or more islet autoantibody to GAD, IA2, IAA or islet cell
cytoplasmic antibody (ICA) within 2 weeks of diabetes diagnosis.

Exclusion Criteria:

- Subjects under 18 years of age or over 35 years of age.

- Subjects who have previously received an organ transplant.

- Subjects who are currently receiving systemic corticosteroids for other medical
diseases in which the physician feels discontinuation of corticosteroids is
contraindicated.

- Subjects with a history of other medical condition(s) known to affect blood glucose
values (i.e., Cushing's disease, acromegaly).

- Subjects with a history of other chronic systemic inflammatory or autoimmune disease
or other severe medical condition. (A history of treated hypothyroidism with
documentation of normal serum thyroid hormone levels will not be exclusionary.)

- Patients with a history of hepatitis B, hepatitis C, or HIV.

- PPD positive at the time of evaluation.

- Thrombocytopenia or neutropenia. Individuals will be considered to have
thrombocytopenia if they have a platelet count <100,000 platelets/mm2 or <3,000
WBC/ml.

- Subjects with a history of renal, pulmonary, or cardiac failure

- Subjects with severe systemic infections. Only those subjects who have completed
treatment and have shown a complete clinical resolution will be considered eligible
for the study.