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

Provention Bio, a Sanofi Company

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: teplizumab 1 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04270942

SFY18115 (Other Identifier)

PRV-031-002

Details and patient eligibility

About

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.

Full description

The study was a single-arm, multicenter, open-label clinical trial. All participants received a 12-day course of teplizumab given through daily IV infusion and were followed for 78 weeks.

The purpose of this study was to evaluate the safety and tolerability of teplizumab treatment, administered intravenously (IV) to participants in the NIH-sponsored trial who have developed type 1 diabetes and were able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. Whether teplizumab treatment reduced the loss of insulin-producing pancreatic beta cells were evaluated.

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Teplizumab treated

Experimental group

Description:

Administration of teplizumab by intravenous infusion for 12 consecutive days

Treatment:

Drug: teplizumab 1 mg/mL