Study Details Currently Enrolling

The ASCEND T1D Study is testing anti-thymocyte globulin (ATG) and teplizumab to compare their ability to delay the onset of type 1 diabetes (T1D) in people at high risk.

A previous TrialNet study of teplizumab in people at high risk found it can delay clinical diagnosis by 2+ years. This study was instrumental in the FDA’s approval of teplizumab as the first treatment to delay T1D progression.

Another TrialNet study for people newly diagnosed with T1D found ATG improved insulin production and hemoglobin A1c (an indicator of long-term blood sugar levels) for 2 years.

If the ASCEND T1D Study finds ATG is comparable to teplizumab in delaying T1D in people at high risk, TrialNet may conduct an extension study to further test ATG’s ability to slow disease progression.

Who Can Participate

  • Ages 4 to 34
  • Stage 2 T1D confirmed by TrialNet testing (at least 2 diabetes-related autoantibodies and abnormal glucose tolerance)
  • Not diagnosed with Stage 3 T1D (clinical diagnosis)

A research team member will go over the full list of eligibility criteria with you.

Randomization

This study will enroll 60 people in Stage 2 T1D. Everyone in the study will receive one of the study treatments. There is no placebo.

  • 2 out of every 3 participants (40 people) will receive ATG.
  • 1 out of every 3 participants (20 people) will receive teplizumab.

A computer will randomly assign each participant to a study treatment. Before the first infusion, participants will learn which treatment has been assigned to them.

Study Enrollment Timeline

We estimate it will take about 3 years to enroll all 60 participants. After everyone has completed the treatment phase of the study, researchers will analyze early data to compare disease progression in each group. We will use the same scoring method we used in the TrialNet Teplizumab Prevention Study. The results will help us to decide whether to do an extension study to further test ATG’s ability to slow disease progression. We may invite you to participate in the extension study.

Participant Experience

How long you are in the study will depend on when you join. Everyone will be in the study for at least 1 year; some will be in the study for 3-4 years.

Treatment

Participants in the ATG group will receive 2 infusions over 2-3 days.

Participants in the teplizumab group will receive 14 daily infusions over 2 weeks.

Follow-up

In the follow-up phase, all participants will visit their study site at months 3, 6, and 12, then every 6 months until the study ends.

Total time in the study is similar for those assigned to either treatment group.

Additional Tests and Monitoring

Most study visits include routine tests, such as physical exams, blood tests, and urine collection. At some visits, you will have an oral glucose tolerance test (OGTT) to determine how much insulin your body is making in response to glucose (sugar). This test involves drinking a sweet liquid that contains glucose, followed by a blood draw. An intravenous (IV) catheter is used, so there’s only one poke while small amounts of blood are collected over 2 hours.

At certain times during the study, TrialNet will provide you with a special continuous glucose monitor (CGM) to wear for 7 days. Unlike a typical CGM, this one won’t allow you to see your blood sugar levels.

How to Sign Up

If you are in TrialNet Monitoring

If you are currently being monitored by TrialNet, your research team will contact you to discuss your eligibility for this study. You can also reach out to your team to let them know you are interested.

 

If you have 2 or more autoantibodies identified outside TrialNet

If you have been screened elsewhere and tested positive for 2 or more autoantibodies, please fill out the Study Interest Form below. A TrialNet research team member will contact you to discuss next steps.

 

If you have never been screened

If you have a relative with T1D and have not been screened, the first step is to sign up for TrialNet risk screening. TrialNet screens family members starting at age 2.

 

For more information about this study or TrialNet, please email us: info@trialnet.org.

 

Benefits of Being in this Study

Participants will receive intensive diabetes management. Research has shown that keeping blood glucose levels within a healthy range reduces the risk of long-term complications. It may also help any remaining beta cells continue to make some insulin.

If you develop T1D, our tests will likely show this before you have any symptoms. For people taking part in T1D research, the risk of diabetic ketoacidosis (DKA) at diagnosis drops from more than 30% to less than 3%. DKA is a serious condition that can be life-threatening.

Like all clinical research, there are benefits and risks to participating in this study. Before you join the study, a TrialNet team member will explain all potential benefits and risks and answer your questions.