To our Teplizumab study participants and their families — thank you for making the decision to participate. Your contributions are helping us all learn more and moving us closer to the prevention of type 1 diabetes. Participants are truly the most important members of our research team.

• A member of your research team will contact you shortly to schedule a time to review your results. If you have questions, please contact your study team or email info@trialnet.org 
• If you have not developed type 1 diabetes, we encourage you to talk to your study team about enrolling in close monitoring in Pathway to Prevention
• If you developed type 1 diabetes and haven’t already joined the LIFT Study (Long-Term Investigative Follow-Up in TrialNet), we encourage you to talk to your study team about participating. This study gives participants personal ongoing monitoring by experts at the forefront of type 1 diabetes research.
   

Hello. I am Dr. Kevan Herold a Professor of Immunobiology and Medicine at Yale University.

As a TrialNet Principal Investigator and the Chair of the Teplizumab/Anti-CD3 prevention trial, I’m excited to share with you the results of the study with you. Before I begin, I first want to say thank you to our study participants and their families for the vital role they played in this important research. Without your contribution, advancements in diabetes research would not be possible.

Today, I am proud to announce that this is the first study to show that teplizumab can at least delay the diagnosis of type 1 diabetes in those who are at risk for being diagnosed with the disease but do not yet have it.

For those of you not familiar with the study, I want to share a quick summary of the trial and how it was conducted. The goal of this study was to find out if teplizumab, also called Anti-CD3 antibody, could delay the diagnosis of diabetes in people who are likely to develop the disease.  The idea for this study was based upon previous research that had shown that this immunomodulatory drug was beneficial in newly diagnosed patients with type 1 diabetes and maintained the patient’s own insulin production.

This prevention study had 76 participants between the ages of 8 and 45; everyone had a relative with type 1 diabetes. Each person had two or more type one diabetes autoantibodies and some abnormality in their blood sugar response during an oral glucose tolerance test. However, they did not have symptoms, and they did not have type 1 diabetes. The lifetime risk of being diagnosed with type 1 diabetes in this group nears 100%. About half of the participants received teplizumab and about half received a placebo. No one knew who was receiving the study drug or placebo until the study ended.

Over the course of the entire trial, 72% of those who had received placebo were diagnosed with Type 1 diabetes – half within the first two years. In contrast, only 43% of those who were treated with teplizumab developed diabetes, and even those who developed it, it was delayed. Half of the teplizumab treated group had not been diagnosed with diabetes by 4 years. We are continuing to follow all of the participants.

The goal of this and our other TrialNet studies is to identify ways to delay or even completely prevent the diagnosis of type 1 diabetes in those who are destined to get it. This trial is the first achievement towards that goal. We are very excited about these results – they are highly statistically significant and medically important. We are now trying to understand why some people responded better to teplizumab than others, and we will also look for ways to extend the benefits of teplizumab.

As we all know, delaying type 1 diabetes for as long as possible is important. It is particularly important for children, who were the majority of the study participants. For those of you who have children who were in the trial, I hope you will share these results with them and let them know how thankful we are and how proud they should feel regardless if they received teplizumab or placebo.

I am reminded of an 11-year-old girl who participated in another one of our clinical studies of teplizumab. Traveling to our site in Connecticut all the way from her home in Maine, she never missed a study visit. I once asked her why she wanted to participate in this study particularly since it was so far for her mom to travel so frequently. She told me that she had a teacher who had type 1 diabetes and she thought that by participating in this trial that she might be able to help her teacher. By your participation in this trial, you have helped all of the families of people with diabetes today and in the future.

All of us at TrialNet deeply appreciate everyone who participated in this important research – those who enrolled and those who enabled participants to join the trial. Now, in addition to being able to accurately predict who will develop type 1 diabetes, we have found a way to at least delay it. This is a huge breakthrough that gets us one step closer to our ultimate goal: A future without type 1 diabetes. Thank you.