Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
60 participants
Jul 29, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Thymoglobulin
Intravenous infusions of teplizumab given for 14 consecutive days. For participants ages 8-34 each infusion will take a minimum of 30 minutes. For participants ages 4-7 each infusion will take a minimum of 2 hours. Each infusion will also be followed by an observation period of at least 30 minutes.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07216391