Rituximab in New Onset Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      The study is a randomized, two-arm, trial in which 2/3 of participants will receive the study
      drug, while the remaining 1/3 will receive a placebo (a pretend medicine that does nothing).
      The group you are assigned to is decided by chance (as by the toss of a coin or drawing
      straws). Neither you nor your doctor will be able to choose which group you are in. Also,
      neither you nor the researchers will know which group you are in. Participants will take
      rituximab, or the placebo, once a week during the first 4 weeks in the study. It will be
      given as an intravenous infusion at a clinical center.

      Participants will need to return to the clinical center for a visit about every 3 months for
      two years; those participants that continue to secrete insulin will have further follow-up
      for an additional two years.
    

Intervention name(s): Anti-CD20 (rituximab); Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Placebo intravenous infusion
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Newly diagnosed type 1 diabetes; New Onset type 1 diabetes; Preservation of insulin secretion; Type 1 diabetes; Juvenile Onset Diabetes; Insulin Dependent Diabetes; T1D