Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects

Inclusion Criteria: * Age 3 to 45 years - Insulin dependent type 1-diabetes mellitus diagnosed within the previous 3 months * Stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted 3 weeks from diagnosis of diabetes * Presence of GAD65 antibodies * At least one month from last immunization * Willing to comply with intensive diabetes management * If participant is a woman with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test * Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration Exclusion Criteria: * Immunodeficiency or clinically significant chronic lymphopenia * Active infection * Positive PPD test result * Pregnant or lactating or anticipating becoming pregnant for 24 months following first injection * Ongoing use of medications known to influence glucose tolerance * Require use of systemic immunosuppressant(s) * Serologic evidence of current or past HIV, Hep B, or Hep C infection * History of malignancies * Ongoing use of non-insulin pharmaceuticals to affect glycemic control * Participation in another clinical trial with a new chemical entity within the past 3 months * Complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological, or clinically significant blood count abnormalities (such as lymphopenia, le…