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

The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Inclusion criteria

Subjects must meet all of the following criteria:

• Enrollment (Segment #1) or randomization (Segment #2) on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. Study Day 0 is the first day of study drug dosing.
• Diagnosis of type 1 diabetes mellitus, according to the American Diabetes Association (ADA) criteria
• Requirement for injected insulin therapy
• Have a detectable fasting or stimulated C-peptide level (above the lower limit of detection of the assay)
• One positive result on testing for any of the following antibodies:

• islet-cell autoantibodies (ICA512/IA-2),
• glutamic acid decarboxylase autoantibodies, or
• insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)
• Male or female
• Subject must be in one of the following age groups:

• Age 18-35 years
• Age 12-17 years pending approval by Data Monitoring Committee
• Age 8-11 years pending approval by Data Monitoring Committee
• Body weight ≥ 36 kg

Exclusion criteria

Subjects must have none of the following:

• 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
• Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization
• Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
• Pregnant or lactating females
• Prior murine OKT®3 treatment at any time before enrollment or randomization
• Current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion
• Current or planned therapy with inhaled insulin
• 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
• History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease
• Newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active Graves' disease
• Eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization
• Evidence of active infection, such as fever ≥ 38.0 degrees Celsius (100.5 degrees Fahrenheit)
• Known or suspected infection with human immunodeficiency virus (HIV)
• Evidence of active hepatitis B (HBV) or hepatitis C virus (HCV)
• Evidence of active or latent tuberculosis
• 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.
• Any infectious mononucleosis-like illness within the 6 months before enrollment or randomization
• Serologic and clinical evidence of acute infection with Epstein-Barr virus (EBV)
• Serologic evidence of acute infection with cytomegalovirus (CMV)