ATG-GCSF in New Onset Type 1 Diabetes

Type 1 diabetes (T1D) is an autoimmune disease, meaning that the immune system mistakenly attacks the cells in the body that make insulin. These cells, called beta cells, are found in the pancreas. Beta cell destruction starts years before symptoms appear. By the time T1D has been diagnosed, many beta cells have already been destroyed, but some are still left that can produce insulin. People who can continue to make a little insulin may have fewer problems with low blood glucose (hypoglycemia). They may also have an easier time keeping their blood glucose at normal levels. This helps lower the risk of long-term complications. At this time, there is no proven treatment that will protect the remaining beta cells. The body's immune system keeps destroying them. Within a few years after diagnosis, most people with T1D can no longer make their own insulin.

The TrialNet 19 (TN19) study was a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which participants either received active Anti-Thymocyte Globulin (ATG) and Granulocyte Colony Stimulating Factor (GCSF), received ATG alone, or received a placebo alone within 100 days from diagnosis of T1D. TrialNet researchers assessed whether ATG used alone or in combination with GCSF helped participants continue to make some of their own insulin.

The study had a treatment phase and a follow-up phase. The treatment phase was during the first 3 months of the study. During this time, participants had one inpatient stay for 3 days and 2 nights to receive two infusions of low dose ATG or placebo followed by one injection of GCSF or placebo. Participants returned for five additional outpatient visits over the next 10 weeks (every 2 weeks) to receive an injection of GCSF or placebo. After the treatment phase, participants moved to the follow-up phase and returned for outpatient visits every 3 to 6 months. The study had a total participation time of two years.