Clinical Study: Type 1 Diabetes (T1D)
ASCEND T1D
Status: Enrolling
Email: diabetes@benaroyaresearch.org
Phone: (800) 888-4187
Study Summary
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.
Eligibility Criteria
The following people may be eligible:
- 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.
What will study participants be asked to do?
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.
