Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Condition: Autoantibody Positive; Non-diabetic Relatives at Risk for Type 1 Diabetes; High Risk; Impaired Glucose Tolerance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Intolerance
Intervention: Teplizumab; Placebo infusion
Intervention description: intravenous infusions; Placebo for Teplizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 8 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: type 1 diabetes; pre-diabetic; autoantibody positive; at risk for type 1 diabetes; glucose intolerance; relatives of people with type 1 diabetes

Summary:

      The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to
      prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very
      high risk for developing the disease. Teplizumab has been studied in new onset type 1
      diabetes for testing of efficacy and safety in previous studies; other studies are currently
      in progress. The results of previous studies indicate that teplizumab reduces the loss of
      insulin production during the first year after diagnosis in individuals with type 1 diabetes.
      The purpose of this study is to determine if teplizumab can interdict the immune process that
      causes the destruction of insulin secreting beta cells in the pancreas during the
      "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.
    

Eligibility criteria:

        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