Last updated on January 2015

AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Mellitus | Type 1
  • Age: Between 8 - 45 Years
  • Gender: Male or Female

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]
  • Labnormalities in blood counts, liver enzymes, INR
  • Positive 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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