“This is an interesting and very promising study,” said Berrie Center Co-Director Robin Goland, the J. Merrill Eastman Professor of Clinical Diabetes, about a new TrialNet research study that shows low-dose thymoglobulin (ATG) slows insulin loss in people newly diagnosed with type 1 diabetes (T1D). The findings were presented last month at the 2018 American Diabetes Association’s Scientific Sessions in Orlando, FL.
TrialNet researchers wanted to know if ATG alone or in combination with granulocyte colony-stimulating factor (GCSF) could slow insulin loss when started in people with early-onset T1D. To find out, the group enrolled 89 people between ages 12 and 45 diagnosed with type 1 diabetes in the past 100 days. Some people received ATG, some received ATG combined with GCSF and others received a placebo.
ATG is approved by the FDA to prevent or treat acute rejection of a transplanted organ. A previous pilot study tested ATG in combination with GCSF, an FDA-approved drug used to increase white blood cell counts in people receiving chemotherapy. The pilot study also suggested that ATG combined with GCSF preserved insulin production for more than 1 year after treatment in people who had T1D for 4 months to 2 years.
One year after the start of treatment, researchers concluded that low-dose ATG preserved beta cell function and improved insulin production. Low-dose ATG combined with GCSF did not enhance beta cell preservation. Hemoglobin A1c levels were significantly lower (indicating better long-term blood sugar control) in people treated with low-dose ATG alone and in people treated with low-dose ATG combined with GCSF, as compared to placebo.
Study Chair and TrialNet Investigator Michael Haller, MD, from the University of Florida said, “We are excited to share these important findings with all those affected by type 1 diabetes and are eager to conduct studies designed to test ATG even earlier in the disease process, prior to symptoms and clinical diagnosis.”
All participants will complete the study by August 2018. Final findings will be reported in 2019.
Added Dr. Goland, “I look forward to seeing more results.”