The Immune Tolerance Network's (ITN's) T1DAL research trial for recently diagnosed type 1 diabetes has recently received the approval of its Data Safety Monitoring Board (DSMB) to begin accepting patients in the younger cohort, ages 12-15 years, into the study. The decision was made after a review of safety data from the initial group of 10 adult-age subjects enrolled into the study. The trial is now open to individuals between the ages of 12-35 who have been diagnosed with type 1 diabetes within the past 3 months.
The T1DAL trial is being led under the direction of protocol chair, Dr. Mark Rigby at the Riley Hospital for Children at Indiana University, Indianapolis. It is a research project conducted by the ITN and is sponsored by the National Institute of Allergy and Infectious Diseases.
Type 1 diabetes is an autoimmune disease caused by an immune system attack on the insulin-producing beta cells located in the pancreas. Type 1 diabetes can emerge suddenly and as beta cells are destroyed, the ability to produce insulin is decreased. The goal of the T1DAL 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.
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 has received FDA approval to treat another autoimmune disease called chronic plaque psoriasis.
The T1DAL trial, short for "Inducing Remission in New-onset Type 1 Diabetes with Alefacept", is a randomized, placebo-controlled research study that aims to enroll a total of 66 patients at 19 clinical centers across the US.
More information about the T1DAL trial is available http://www.t1dal.org