At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.

Key facts

Study ID

NCT04270942

Run by

Provention Bio, a Sanofi Company

People needed

6

Starts

2020-02-26

Expected to finish

2024-01-22

Last updated by the study team

2025-02-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous participant in the TN-10 study
• Participant had received a diagnosis of type 1 diabetes after the conclusion of the TN-10 study, according to the criteria from the American Diabetes Association (ADA).
• Participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
• Participant was willing to forego other forms of experimental treatment during the entire study.
• Participant and/or guardian had given informed consent and assent as applicable.

You may not qualify if…

• Had an active infection and/or fever.
• Had a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
• An individual who had a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.

Where it is running

• Barbara Davis Center for Diabetes Site Number : 04 — Aurora, Colorado, United States
• Clinical Site — Aurora, Colorado, United States
• Yale University School of Medicine Site Number : 01 — New Haven, Connecticut, United States
• Clinical Site — New Haven, Connecticut, United States
• Clinical Site — Gainesville, Florida, United States
• University of Florida Site Number : 02 — Gainesville, Florida, United States
• Clinical Site — Nashville, Tennessee, United States
• Vanderbilt Univerity Medical Center Site Number : 03 — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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