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

CompletedPhase 2

Sponsor: Provention Bio, a Sanofi Company

Conditions: Diabetes Mellitus, Type 1

Interventions: teplizumab 1 mg/mL

Countries: United States

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Previous participant in the TN-10 study
2. 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).
3. Participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
4. Participant was willing to forego other forms of experimental treatment during the entire study.
5. Participant and/or guardian had given informed consent and assent as applicable.

Exclusion Criteria:

1. Had an active infection and/or fever.
2. 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).
3. 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.

Locations (8)

Aurora, Colorado, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
Gainesville, Florida, United States
Gainesville, Florida, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States