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TrialNet TN10 Anti-CD3 Teplizumab Prevention of Type 1 Diabetes in Relatives “At Risk”


Purpose

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.

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

For Additional Information:

Lisa Meyers MSW, CDE  Enrollment Coordinator  303-724-6893  Lisa.Meyers@ucdenver.edu

www.diabetestrialnet.org