The T1DAL ITN045AI clinical research study for recently diagnosed type 1 diabetes has completed enrollment at 19 clinical centers across the U.S. T1DAL is a randomized, placebo-controlled research study for participants between the ages of 12-35 and recently diagnosed with type 1 diabetes. The goal of this trial is to determine whether the drug alefacept (Amevive ®) can delay or permanently halt the destruction of beta cells in new-onset type 1 diabetes. If the destruction of the beta cells is stopped, the body might be able to produce insulin on its own longer, which could stop or slow progression of the disease.
Alefacept is a fusion protein that interferes with T cells, the subset of the immune system implicated in the destruction of beta cells. Although considered an experimental treatment for type 1 diabetes, alefacept is already in use and FDA-approved for treating chronic plaque psoriasis, another autoimmune disease.
This clinical trial is under the direction of protocol chair, Dr. Mark Rigby at the Riley Hospital for Children at Indiana University, Indianapolis. T1DAL is a research project conducted by the Immune Tolerance Network (ITN), a research consortium sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).