The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Exclusion Criteria

• •Subjects must have none of the following:
• •1. Prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at Study Day 0 -- that could potentially prevent or confound a therapeutic response to MGA031
• •2. Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization
• •3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
• •4. Pregnant or lactating females
• •5. Prior murine OKT®3 treatment at any time before enrollment or randomization
• •6. Current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion
• •7. Current or planned therapy with inhaled insulin
• •8. Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization
• •9. History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease
• •10. Newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active Graves' disease
• •11. Eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization
• •12. Evidence of active infection, such as fever ≥ 38.0 degrees Celsius (100.5 degrees Fahrenheit)
• •13. Known or suspected infection with human immunodeficiency virus (HIV)
• •14. Evidence of active hepatitis B (HBV) or hepatitis C virus (HCV)
• •15. Evidence of active or latent tuberculosis
• •16. Vaccination with a live virus within the 8 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. Vaccination with an antigen or killed organism must not be given within 8 weeks before or planned within 8 weeks after each dosing cycle.
• •17. Any infectious mononucleosis-like illness within the 6 months before enrollment or randomization
• •18. Serologic and clinical evidence of acute infection with Epstein-Barr virus (EBV)
• •19. Serologic evidence of acute infection with cytomegalovirus (CMV)