Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
Eligible age
4–34 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstrates a positive signal and as decided by TrialNet, there is potential for a study extention. This would extend follow-up visits for a possible study duration of about 9 years among the earliest enrollees of the initial study.
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
You may qualify if…
- ✓ Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \<18 years of age.
- ✓ Aged ≥4 to \<35 years
- ✓ A history of at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this trial.
- ✓ Participants must meet ADA stage 2 T1D glycemic criteria\* by TrialNet testing within 100 days of the baseline visit.
- ✓ \*The ADA definition of stage 2 T1D is characterized by glucose intolerance or dysglycemia in the presence of two or more islet autoantibodies, impaired fasting glucose (≥ 100mg/dL), impaired glucose tolerance (2-hour post 75g glucose load ≥ 140mg/dL), high glucose levels at intermediate time points on OGTT (30, 60, 90 min timepoints of ≥ 200 mg/dL), and/or HbA1c between 5.7% and 6.4% or ≥ 10% increase in HbA1c within a two year window, with the most recent HbA1c value obtained within 100 days of the baseline visit.
- ✓ Participants, regardless of serostatus, must meet all of the following:
- ✓ Be EBV and CMV PCR negative prior to randomization
- ✓ Be EBV and CMV PCR negative within 2 weeks prior to the baseline visit
You may not qualify if…
- ✕ Immunodeficiency or clinically significant chronic lymphopenia: (Leukopenia (\<3,000 leukocytes/μL), neutropenia (\<1,500 neutrophils/μL), lymphopenia (\<1000 lymphocytes/μL), thrombocytopenia (\<150,000 platelets/μL).
- ✕ Hemoglobin less than 13 g/dL for adult men and less than 11.5g/dL for adult females and less than 11 g/dL for participants under age 18.
- ✕ Active signs or symptoms of acute or chronic infection at the time of the baseline visit including SARS-Cov-2.
- ✕ Uncontrolled autoimmune thyroid disease and/or celiac disease (participants must be well controlled for the previous 6 months).
- ✕ Evidence of prior or current tuberculosis infection through any one or more of the following:
- ✕ 1. A history of latent or active TB
- ✕ 2. Signs and/or symptoms of TB
- ✕ 3. Recent close contact with a person with known or suspected active TB unless appropriate prophylaxis for TB was given
Where it's recruiting
Aurora
New Haven
Gainesville
New York
Pittsburgh
Seattle
Source: ClinicalTrials.gov · NCT07216391 · last updated 2026-09-09