The AbATE Trial for Type 1 Diabetes Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these beta cells and the insulin they produce, the body cannot properly metabolize food or provide glucose to organs that require it for daily activities. By the time someone has been diagnosed with type 1 diabetes, a substantial proportion -- likely 60-85% -- of a person's beta cells have already been destroyed. The good news is that between 15-40% of these cells are generally alive and may still be able to produce insulin just as they should. If these remaining healthy beta cells can be preserved, it is believed that a prolonged remission period may occur that can decrease or eliminate the need for insulin injections and ultimately lead to a decrease in the secondary complications of type 1 diabetes. The AbATE TRIAL The AbATE Trial is testing a new experimental antibody therapy known as "teplizumab" [or hOKT3γ1(Ala-Ala)] to determine whether it can halt any further loss of beta cells by establishing a state of immune "tolerance" towards the beta cells. In a smaller exploratory clinical trial, patients receiving a single, 2-week treatment with hOKT3γ1(Ala-Ala) had preserved beta cell function and lower insulin requirements than untreated patients for up to two years after therapy (see graphs below). The initial results of this study were published in the New England Journal of Medicine in 2002, and 2-year follow-up results were published in the journal Diabetes in 2005.
The AbATE study is a new study that aims to further investigate the ability of teplizumab to prevent the progression of type 1 diabetes after its onset. In the AbATE study, a second, additional treatment with teplizumab will be given one year after the first in order to determine if it can prolong and/or improve the preservation of beta cell function that was observed in the preliminary studies with a single course of therapy. The study is open to individuals 8-30 years of age who have been diagnosed with type 1 diabetes within the past 8 weeks. Study Design The AbATE Trial is taking place at six study centers in the United States and plans to enroll 81 participants. It is a randomized, two-arm, open-label phase II trial in which 2/3 of participants will receive the study drug plus standard diabetes management, while the remaining 1/3 will receive standard diabetes management only. Participants will be followed for up to 5 years after completing therapy to assess their overall diabetes health and to evaluate laboratory measures of beta cell and immune system function. To learn more about the study drug, teplizumab [or hOKT3γ1(Ala-Ala)], click here. To learn more about who may participate, click here.
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More Information for patients Drug slows diabetes in young patients Drug shows great promise against juvenile diabetes The little antibody that could for physicians Pilot phase I/II trial results in new onset diabetes at 1 year - NEJM 2002 (pdf) Pilot phase I/II trial results in new onset diabetes at 2 years
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