Study Confirms Positive Lasting Effects of Low-dose Thymoglobulin® in Newly Diagnosed Type 1 Diabetes
Findings from a TrialNet clinical study published in Diabetes show low-dose Thymoglobulin® preserved insulin production and improved long-term blood sugar control for 2 years in people newly diagnosed with type 1 diabetes. Thymoglobulin® is approved by the Food and Drug Administration (FDA) for prevention and treatment of kidney transplant rejection.
TrialNet researchers wanted to know if Thymoglobulin® alone or in combination with Neulasta®, an FDA-approved drug used to increase white blood cell counts in people receiving chemotherapy, could slow insulin loss when started soon after diagnosis. To find out, they enrolled 89 people between ages 12 and 45 diagnosed with type 1 diabetes in the past 100 days. Some people received Thymoglobulin®, some received Thymoglobulin® combined with Neulasta®, and others received a placebo.
Two-year findings confirm continuation of the positive effects reported 1 year after the start of treatment (Diabetes Care, September 2018):
- Low-dose Thymoglobulin® preserved beta cell function and improved insulin production.
- Hemoglobin A1c levels were significantly lower (indicating better long-term blood sugar control) in people treated with low-dose Thymoglobulin® alone and those treated with low-dose Thymoglobulin® combined with Neulasta®, as compared to placebo.
“The fact that results are being maintained for 2 years is highly significant,” said Study Chair and TrialNet Investigator at University of Florida, Michael Haller, M.D. “Any approach that allows people with type 1 diabetes to produce more of their own insulin and maintain better blood glucose control for this long demonstrates progress towards our ultimate goal of preventing and reversing this terrible disease.”
This research is the result of collaborative funding over the past 10 years from the National Institutes of Health (NIH), The Leona M. and Harry B. Helmsley Charitable Trust, and Sanofi, with additional support from JDRF and the American Diabetes Association. This approach is still experimental and requires additional research prior to being widely available to people with type 1 diabetes.
“This project shows the power of collaboration in moving research forward,” said Helmsley Type 1 Diabetes Program Director Gina Agiostratidou, Ph.D. “Thanks to long-term support from several organizations, we’re a step closer to using this knowledge to benefit people with type 1 diabetes.”
For more information, visit www.trialnet.org.
About the Helmsley Charitable Trust
The Leona M. and Harry riB. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $2 billion for a wide range of charitable purposes. For more information, visit www.helmsleytrust.org.