Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"

Inclusion Criteria:

   - Between ages of 8-45 years

   - Have a relative with type 1 diabetes

   - If first degree relative must be 8-45 years old (brother, sister, parent, offspring)

   - If second degree relative must be between 8-20 years old (niece, nephew, aunt, uncle,
   grandchild, cousin)

   - Abnormal glucose tolerance by OGTT confirmed with 7 weeks of baseline visit [fasting
   blood glucose greater than 110mg/dL or and less than 126 mg/dL OR 2 hour glucose
   greater or equal to 140 mg/dL and less than 200 mg/dL OR 30, 60, or 90 minute value on
   OGTT greater than or equal to 200 mg/dL]

   - Presence of at least two confirmed diabetes autoantibodies

Exclusion Criteria:

   - type 1 diabetes previously diagnosed or detected at screening [fasting glucose greater
   or equal to 126 mg/dL or 2 hour glucose greater or equal to 200 mg/dL]

   - abnormalities in blood counts, liver enzymes, international normalised ratio (INR),

   - positive purified protein derivative (PPD) test

      - vaccination with live virus within 6 weeks of randomization

   - evidence of acute infection based on laboratory testing or clinical evidence

   - serological evidence of past current or past HIV , hepatitis B, or hepatitis C
   infection

   - Be currently pregnant or lactating

   - Prior treatment with study drug

   - Prior treatment with other monoclonal antibody in past one year