The success of every clinical trial depends on its participants. When people step off the sidelines and join clinical trials, amazing progress can happen. The type 1 diabetes community witnessed this kind of stunning breakthrough in the summer of 2019. TrialNet’s Teplizumab Prevention Study showed that teplizumab, a drug that targets the immune system, can delay type 1 diabetes (T1D) a median of two years in children and adults at high risk.
“In addition to being able to accurately predict who will develop T1D, we have now found a way to delay it. This is an incredible advancement that gets us one step closer to our ultimate goal: a future without T1D. Relatives of people with T1D are urged to get screened for risk at TrialNet.org,” said Carla Greenbaum, MD, director of the diabetes research program at Benaroya Research Institute.
With the landmark teplizumab study followed by the 2022 FDA approval of the drug, we have entered an exciting new era in T1D therapy—one where we can treat the underlying immune system attack that causes disease before symptoms begin. Just as other autoimmune conditions have several treatments available to change the course of the disease, T1D will have many options in the future — teplizumab is just the first!
The road to teplizumab approval began decades ago when people stepped up to volunteer for studies. Today, TrialNet needs volunteers for a new T1D prevention study called STOP-T1D that is testing low- dose Anti-Thymocyte Globulin (ATG).
Type 1 diabetes occurs when effector T cells (Teff), a type of immune cell, mistakenly attack the insulin-producing beta cells in the pancreas. ATG temporarily reduces Teff cell levels while preserving Regulatory T cells (Tregs) that help keep Teff cells in check. This interrupts the immune attack on the beta cells.
In a previous study of people who were newly diagnosed with T1D, ATG preserved insulin production for at least two years after participants received the medication. Based on this exciting result, TrialNet launched the STOP-T1D trial to ask whether low-dose ATG given at an earlier stage can prevent or delay diagnosis.
STOP-T1D is enrolling high-risk children and adults in Stage 2 of T1D (people in Stage 2 of T1D have two or more T1D autoantibodies, abnormal glucose tolerance, and no symptoms). If you have a family member with T1D, you can screen with TrialNet to learn if you may be eligible to join STOP-T1D.
With the help of study volunteers, we are moving toward a future where T1D will be treated before symptoms start. The STOP-T1D clinical trial brings us one step closer to that goal.
Please contact Benaroya Research Institute to learn more: email diabetes@benaroyaresearch.org or call 800-888-4187 or visit TrialNet.org to sign up to be screened for risk.
The study drug ATG temporarily reduces Teff attacker cells, while preserving regulatory T cells (Tregs) that help keep the attacker cells in check.
You may be eligible to join STOP-T1D if you:
- Are age 12 – 34
- Have two or more autoantibodies identified through TrialNet
- Have a history of abnormal glucose tolerance
– Dr. Sandra Lord, a principal investigator and research physician at Benaroya Research Institute (BRI), is Clinical Director of BRI’s Center for Interventional Immunology.
