Can a Two-Dose drug delay type 1 diabetes as well as a 14-Day treatment?
NCT ID NCT07216391
First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This study compares two drugs, ATG and teplizumab, to see if they can delay or prevent type 1 diabetes in people who are at high risk. About 60 participants aged 4 to 35 will receive either two infusions of ATG or 14 daily infusions of teplizumab. Researchers will monitor them for at least a year to see how well each drug works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Antithymocyte Globulin (ATG) or Teplizumab
- What this could lead to
- If successful, this could offer another treatment option to delay the onset of type 1 diabetes in people at high risk.
- What could go wrong
- This is a small, early-phase study with only 60 participants. It may not show a clear benefit, and the effects may not last long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 34 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Have no 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 Criteria: * 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 4. A history of a chest X-ray consistent with active TB or old, inactive TB, or interferon gamma release assay IGRA (QuantiFERON) test 5. A history of a positive purified protein derivative (PPD) skin test result (\>10 mm induration), or positive/repeatedly indeterminate on an interferon-gamma release assay (IGRA; e.g., QuantiFERON-TB test). * 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, Down syndrome, adrenal insufficiency, 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Barbara Davis Center
RECRUITINGAurora, Colorado, 80045, United States
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Benaroya Research Institute
RECRUITINGSeattle, Washington, 98101, United States
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Columbia University
RECRUITINGNew York, New York, 10032, United States
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University of Florida
RECRUITINGGainesville, Florida, 32610, United States
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University of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15224, United States
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Yale University
RECRUITINGNew Haven, Connecticut, 06511, United States
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