Study to Delay Stage 3 Type 1 Diabetes with Teplizumab or ATG
This study is comparing two medications, Teplizumab and Antithymocyte Globulin (ATG), to see if they can delay or prevent Stage 3 Type 1 diabetes. Researchers want to know if ATG works as well as or better than Teplizumab. You might be able to join if you are between 4 and 34 years old and have Stage 2 Type 1 diabetes, meaning you have at least two specific diabetes-related autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) in your blood. The main goal is to see how these treatments affect your diabetes progression after six months. The study plans to enroll 60 participants. The current recruitment status is unclear.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you receive. It will involve 60 participants who will be randomly assigned to receive either Teplizumab or ATG.
- What's involved
- You would receive either 2 infusions of ATG over 2-3 days or 14 daily infusions of Teplizumab. You will have in-person visits for at least 12-48 months, with the possibility of extending to about 9 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12-48 months after treatment, with a potential extension to about 9 years depending on the study's results.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07216391
Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
Not Yet Recruiting
PHASE2Ages 4–34InterventionalPreventionNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government-funded
~60 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Antithymocyte Globulin (ATG)Teplizumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in DPTRS at six months
Measured over 6 months after completion of study drug administration
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
CMV and/or EBV seronegative participants must be CMV and EBV PCR negative within 30 days prior to randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of the baseline visit.
CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have EBV PCR \< 2,000 IU/mL within 30 days prior to randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days prior to the baseline visit.
Be at least 8 weeks from last live immunization at the time of the baseline visit.
Be willing to forgo vaccines (other than non-live influenza and COVID-19) during the 3 months after study drug treatment period and forgo live vaccines for 12 months after study drug treatment period.
Must meet TrialNet eligibility minimum immunization recommendations found in Appendix A of the manual of operations (MOO).
With the exception of stage 2 T1D, participants must be healthy, as defined by absence of any other untreated diagnoses that the investigator deems to be a potential confounder.
If a female participant with reproductive potential, willing to avoid pregnancy (abstinence or adequate contraceptive method) through the completion of the study infusions and up to 3 months after study drug administration and undergo pregnancy testing prior to each study visit.
Must be residing or have accommodations within 1 hour of the infusion site during study drug infusions and must be within 1 hour of a medical care facility for 1 day after completion of infusions.
Participants must live in a location with rapid access to emergency medical services.
Exclusion
Immunodeficiency or clinically significant chronic lymphopenia: (Leukopenia (\<3,000 leukocytes/μL), neutropenia (\<1,500 neutrophils/μL), lymphopenia (\<800 lymphocytes/μL), thrombocytopenia (\<100,000 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:
Currently pregnant or lactating or anticipate getting pregnant within the study period.
Require use of other immunosuppressive agents including chronic use of oral or intravenous injectable steroids.
Evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.
Any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, COPD, sickle cell disease, neurological disease, or blood count abnormalities.
A history of malignancies other than of skin.
Evidence of liver dysfunction with AST or ALT ≥ 2 times the upper limit of the reference range.
Evidence of renal dysfunction with creatinine ≥ 1.5 times the upper limit of the reference range.
Increased bilirubin ≥ 2 times (total) or ≥ 1.5 times (direct) the normal limit (Participants with documentation of Gilbert's Disease permitted).
Vaccination with a live vaccine within the last 8 weeks or killed/inactivated vaccine within the last 2 weeks of the baseline visit.
Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 14 days of screening.
Prior treatment with Teplizumab or ATG (either in a previous clinical trial or clinically).
Has previously participated in a clinical trial for diabetes prevention and received active study agent within 6 months of treatment.
Known allergy to rabbits or rabbit derived products.
Prior adverse reactions to heparin.
Any condition that in the investigator's opinion may adversely affect study participation.
Any screening/baseline laboratory result not otherwise stated out of normal reference range and/or medical history that may increase the risk of the participant's participation in this trial.
Previously diagnosed with Stage 3 TID according to ADA criteria.
What this trial measures
- Change in DPTRS at six months6 months after completion of study drug administration
DPTRS is calculated as DPTRS = (1.569 x log-BMI) - (0.056 x age) + (0.813 x glucose sum from 30 to 120 min /100) - (0.848 x C-peptide sum from 30 to 120 min/10) + (0.476 x log-fasting C-peptide), where the units are years for age, kg/m2 for BMI, mg/dl for glucose, ng/ml for C-peptide