Researchers are one step closer to preventing type 1 diabetes as new findings show that a drug targeting the immune system can delay Type 1 diabetes for an average of two years in children and adults at high risk.
Dr Anna Clarke of Diabetes Ireland Research Alliance states “this is great news as researchers now can accurately predict who will develop Type 1 diabetes which up to now was 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”.
TrialNet (funded by US National Institutes of Health (NIH) and Juvenile Diabetes Research foundation (JDRF), is a clinical trial network that tests innovative clinical studies to find ways to maintain insulin production before and after diagnosis. Their Teplizumab Pathway to Prevention Study identified 21 adults and 55 children (relatives of people with Type 1 diabetes) who had two or more autoantibodies and abnormal blood sugar levels and therefore were thought to have a lifetime risk of developing Type 1 diabetes nearing 100%.
These high risk individuals were randomly assigned to either the treatment group, which received a 14-day course of teplizumab, or the control group, which received a placebo and followed Participants.
All participants regularly received glucose tolerance tests until the study was completed, or until they developed clinical type 1 diabetes – whichever came first.
Seventy-two percent of people in the control group developed clinical diabetes, compared to only 43% of the teplizumab group. The median time for people in the control group to develop clinical diabetes was just over 24 months, while the median time for the treatment group was 48 months.
Samples collected during the trial are being studied to help researchers understand why certain people responded to teplizumab better than others. Next, TrialNet researchers hope to conduct additional studies to look for ways to extend the benefits of teplizumab. Currently they are conducting two other trials to see if other immune therapy can delay type 1 diabetes.
Of the 76 high risk individuals who participated in the study, 55 were under age 18.demonstrated that Chair, Kevan Herold, M.D. explains: “This is the first study to show any drug can delay type 1 diabetes diagnosis a median of 2 years in people at high risk.
“As anyone with type 1 diabetes will tell you, and particularly for children who are most commonly affected, every day you can delay this disease is important.” Dr. Herold is Professor of Immunobiology and Internal Medicine at Yale University.
All study participants were relatives of people with type 1 diabetes who had two or more autoantibodies and abnormal blood sugar levels as identified by TrialNet’s Pathway to Prevention study. These individuals are thought to have a lifetime risk of clinical diagnosis nearing 100%. Of the 76 high risk individuals who participated in the study, 55 were under age 18.
Karen Addington, UK Chief Executive of type 1 diabetes research charity JDRF, said: “Type 1 diabetes can be tough. We want a cure for those already living with type 1. But we also want to prevent this condition ever developing in those at risk. Learning how to delay onset is the first step.
“Today’s discovery proves the impact of our type 1 diabetes research programme, which is funded by our supporters. My thanks to each and every one of those supporters and to our research partners. We will not waver in our mission to eradicate type 1 diabetes.”
“These results and the potential impact to people living with type 1 diabetes and their families is exactly why JDRF funds prevention research.” said Aaron J. Kowalski, Ph.D., JDRF President and international CEO. “Delaying the progression of the disease is an essential and impactful step toward the prevention, and ultimately a cure for type one, as a delay in diagnosis is likely to have long-term benefits on glycemic control and the development of acute and long-term complications of type 1 diabetes.”
Teplizumab interferes with the body’s immune destruction of its own beta cells. While previous studies showed Teplizumab prolonged insulin production in people recently diagnosed, this is the first study to test it in people at high risk for the disease.
Importantly, this study highlights that type 1 diabetes is an autoimmune disease that can be delayed with immune therapy. TrialNet has several other immune therapy trials aiming to delay type 1 diabetes.
TrialNet Chair Carla Greenbaum, M.D., Director of the Diabetes Research Program at Benaroya Research Institute in Seattle, said: “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 are urged to get screened for risk at TrialNet.org.”
The Teplizumab Prevention Study was primarily funded by NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and JDRF. MacroGenics/Provention Bio donated the study drug and provided funds for additional site monitoring.
TrialNet is an international collaborative endeavour involving 25 clinical centres and hundreds of affiliate sites in the USA, Canada, UK, Sweden, Finland, Germany, Italy, Australia and New Zealand. It recruits around 15,000 research subjects per year and, to date, has tested over 180,000 relatives of people with T1D for the presence of islet autoantibodies.
Teplizumab is an immunosuppresive drug commonly used to treat transplant rejection that interferes in the autoimmune attack of pancreatic beta cells.