Diabetes Mellitus, Type 1
Conditions
Keywords
Recent-onset type 1 diabetes, Teplizumab, T1D, Stage 3, Type 1 diabetes, New onset type 1 diabetes
Brief summary
The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.
Detailed description
This study is the long-term extension of the PRV-031-001 (PROTECT) study. PROTECT is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose. Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study. No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians. Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months.
Interventions
BIOLOGICALTeplizumab
Received teplizumab in PROTECT Study
OTHERPlacebo
Received placebo in PROTECT study
Sponsors
Provention Bio, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
1. Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered. 2. Provide written informed consent within 12 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study.
Exclusion criteria
1\. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies | During 42 months of follow-up | Safety outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the time-versus concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT) | During the 42 months of follow-up | Clinical parameters of diabetes management 1 |
| Insulin use (daily average insulin dose in U/kg/day) | During the 42 months of follow-up | Clinical parameters of diabetes management 2 |
| HbA1c | During the 42 months of follow-up | Clinical parameters of diabetes management 3 |
Countries
Belgium, Canada, Czechia, France, Germany, Poland, United Kingdom, United States
Outcome results
None listed