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The Rituximab Study

Status: No Longer Recruiting

Study Findings

Rituximab helps save insulin production in individuals newly diagnosed

Type 1 diabetes occurs when healthy insulin-producing beta cells are attacked by the body’s own immune system, leaving the beta cells unable to make enough insulin. There is increasing proof that other cells, called B lymphocytes, play a role in the damage. Rituximab is a drug that successfully targets and destroys B lymphocytes.

In a one-year study of 87 people, ages 8-45, insulin production was better preserved in participants who received rituximab infusions compared to those who received a placebo. In addition, individuals who received rituximab infusions used less insulin.

One-year results were reported in November 2009 in the New England Journal of Medicine
At the end of two years, there were no longer any differences between groups in the amount of insulin used. According to scientific standards, there was a beneficial effect at one year from rituximab but none at two years. However, there was a slight tendency in the rituximab group toward more insulin production at two years. 

Further studies will pursue ways to extend the drug’s positive effects.
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