Trial Information

Summary: AbATE Trial for Newly Diagnosed Type 1 Diabetes

Autoimmunity-blocking antibody in newly diagnosed 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, the body cannot maintain proper blood glucose levels in response to daily activities such as eating or exercise.

Generally, at the time of type 1 diabetes diagnosis 60-85% of a person’s beta cells have already been destroyed. However, this also means that between 15-40% of these cells remain and able to produce insulin.

In a smaller exploratory clinical trial, newly diagnosed type 1 diabetes patients receiving a single, 2-week treatment with hOKT3gamma1(Ala-Ala) had preserved beta cell function and significantly lower insulin requirements than untreated patients, for up to two years after therapy.

The AbATE study will investigate whether a second course of the study drug administered one year after the first is able to prolong and/or improve the autoimmunity blocking effects of the drug. The study is open to individuals 8-30 years of age who have been diagnosed with type 1 diabetes within the past 6 weeks.

The AbATE Trial 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 capture laboratory measures of beta cell and immune system function.

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