Dataset from Effects of Rituximab on the Progression of Type 1 Diabetes in New Onset Subjects

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. With fewer insulin producing cells blood glucose increases, causing hunger, thirst,
and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta
cells have already been destroyed. However, this also means that between 10-20% of these
cells remain that continue to produce insulin.

Scientists have learned that two types of immune cells, B cells and T cells, are involved in
causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells
that make insulin. Although they don't attack insulin producing cells, B cells may be what
trigger the T cells to attack.

This study will investigate the use of rituximab to see if it can help lower the number of
immune B cells thereby preventing the destruction of any remaining insulin producing beta
cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration
(FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the
immune system are well understood through its use in organ transplantation. Research has
shown that rituximab might be helpful in treating other conditions caused by T cells and B
cells, including type 1 diabetes. The goal of this study is to find out if rituximab can
preserve residual insulin secretion and prevent further beta cell destruction in type 1
diabetes.