The T1DAL Study has been completed.
The 24 month follow-up results of T1DAL 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, indicating greater preservation 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 recieved alefacept had significantly lower insulin requirements and a significant 50% reduction in major hypoglycemic events.
The 12 month follow-up results of T1DAL were published in The Lancet Diabetes & Endocrinology in December 2013. The primary endpoint, a 2-hour C-peptide response, did not show statistically significant differences between treatment and placebo groups; however, a secondary endpoint, a 4-hour C-peptide response, was significantly higher at 12 months in the treatment group compared to the placebo group. Other secondary endpoints including insulin use and rate of hypoglycemic events were significantly lower at 12 months in the alefacept treated group.