More about these trials below:
The T1DAL study (Inducing Remission in New-onset Type 1 Diabetes with Alefacept) tested whether an investigational drug called alefacept (also called Amevive®) was able to slow or halt the destruction of insulin-producing beta cells in newly-diagnosed type 1 diabetes patients. Alefacept is a biologic that inhibits the activation of T-cells, which are known to be important mediators in the pathogenesis of type 1 diabetes and other autoimmune diseases.
The 12 month follow-up results of T1DAL were published in Lancet Diabetes Endocrinol on September 23, 2003 and the 24 month follow-up results were published in the Journal of Clinical Investigation on July 20, 2015. Individuals with new-onset type 1 diabetes who took two courses of alefacept soon after diagnosis showed significantly lower decline in C-peptide production, an indicator of beta cell function, compared to placebo group. Rates of C-peptide decline varied among individuals in the alefacept group, but 30% showed no decline at all and were considered "complete responders." The patients who received alefacept had significantly lower insulin requirements and a significant 50% reduction in major hypoglycemic events.
The purpose of the AbATE study was to determine whether treatment with teplizumab could halt the progression of newly diagnosed type 1 diabetes. Teplizumab is a biologic that targets the T-cells that are responsible for the immune attack on beta cells.
After 2 years, the teplizumab-treated group showed significantly greater preservation of C-peptide, an indicator of beta cell function, compared to the control group (75% higher responses compared to control), meeting the study’s primary endpoint.
The aim of the EXTEND study is to test whether a therapy called tocilizumab (Actemra®) can stop the immune system from attacking these remaining beta cells and possibly extend the ability to naturally produce insulin. EXTEND is currently enrolling participants and once the EXTEND study visits are completed, participants are asked to see if they are interested in participating in T1DES.