Clinical trial NCT04270942: At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
Official title: An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Recent-onset type 1 diabetes
Teplizumab
T1D
Stage 3
Type 1 diabetes
New onset type 1 diabetes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, multicenter, open-label clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events of Special Interest (TEAESIs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Secondary outcomes:
measure: Serum Concentration Immediately Prior to Administration of the Next Dose (Ctrough) of Teplizumab at Day 364
timeFrame: Pre-dose on Day 364
measure: Number of Participants With Anti-drug Antibodies (ADA) Against Teplizumab
timeFrame: Up to Day 364
measure: Area Under the Time-Versus-Concentration Curve (AUC) of C-peptide After a 4-hour (4h) Mixed Meal Tolerance Test (MMTT) at Week 78
timeFrame: Week 78
measure: Glycated Hemoglobin (HbA1c) Levels at Week 78
timeFrame: Week 78
measure: Average Daily Use of Exogenous Insulin at Week 78
timeFrame: Week 78
measure: Number of Participants With Severe Hypoglycemic Episodes
timeFrame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
measure: Number of Participants With Change in Cluster of Differentiation (CD)8+ TIGIT+ KLRG1+ T Cells
timeFrame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes Site Number : 04
state: Colorado
city: Aurora
country: United States
facility: Clinical Site
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine Site Number : 01
state: Connecticut
city: New Haven
country: United States
facility: Clinical Site
state: Connecticut
city: Gainesville
country: United States
facility: Clinical Site
state: Florida
city: Gainesville
country: United States
facility: University of Florida Site Number : 02
state: Florida
city: Nashville
country: United States
facility: Clinical Site
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univerity Medical Center Site Number : 03
state: Tennessee
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: