RecruitingPhase 2NCT07216391

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


Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

60 participants

Start Date

Jul 29, 2026

Study Type

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

Min Age: 4 YearsMax Age: 34 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Antithymocyte Globulin (ATG) and a drug called Teplizumab for people with type 1 diabetes mellitus. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 4 Years to 34 Years.

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

DRUGAntithymocyte Globulin (ATG)

Thymoglobulin

DRUGTeplizumab

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)

Barbara Davis Center

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

University of Florida

Gainesville, Florida, United States

Columbia University

New York, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Benaroya Research Institute

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07216391


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