Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03875729 · ClinicalTrials.gov registry record · Phase 3
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
A Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Provention Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
- 20
- Study locations
NCT03875729: Completed Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Provention Bio.
NCT03875729 is a Phase 3 study of Type 1 Diabetes Mellitus that has completed, run by Provention Bio. The registered enrollment target is 328 participants, above the 169-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (94% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03875729, a Phase 3 study of Type 1 Diabetes Mellitus, has completed, sponsored by Provention Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
Primary Outcome
The area under the concentration-time curve (AUC) of C-peptide was measured after a 4-hour mixed meal tolerance test (MMTT) and is a measure of endogenous insulin production and β cell function. The AUC was computed using the trapezoidal rule and standardized by the duration of the MMTT test, i.e., AUC was divided by the last blood sample collection time (240 minutes or the last collection time for 4h MMTT).
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL teplizumab
Study Locations (20)
Florida
- UF Clinical and Translation Research Building (Site 015) - Gainesville
- Nemours Children's Specialty Care-Endocrinology (Site 047) - Jacksonville
- University of Miami Health System (Site 028) - Miami
- All Children's Hospital-Johns Hopkins Medicine (Site 048) - St. Petersburg
- University of South Florida Diabetes and Endocrinology Center (Site 011) - Tampa
California
- Rady Children's Hospital-San Diego (Site 004) - San Diego
- UCSF Medical Center (Site 001) - San Francisco
- Diablo Clinical Research, Inc. (Site 002) - Walnut Creek
Georgia
- Atlanta Diabetes Associates (Site 009) - Atlanta
- Centricity Research (Site 006) - Columbus
Idaho
- St. Luke's Children's Endocrinology (Site 052) - Boise
- Rocky Mountain Diabetes and Osteoporosis Center (Site 007) - Idaho Falls
Colorado
- University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005) - Aurora
Connecticut
- Yale University of Medicine (Site 020) - New Haven
Illinois
- University of Chicago Medical Center (Site 017) - Chicago
Indiana
- Indiana University Hospital and Riley Hospital for Children (Site 014) - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2019-04-05 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 3 |
What the finished NCT03875729 record still lists
NCT03875729 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (94% higher).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03875729 names 20 study sites across 12 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03875729 about?
NCT03875729 is a clinical study titled "Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab". The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 mon...
What is the current status of trial NCT03875729?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2019-04-05. Estimated completion is 2023-05-01.
What conditions does trial NCT03875729 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03875729?
The interventions under investigation include: Placebo (BIOLOGICAL), teplizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03875729?
This trial is sponsored by Provention Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03875729 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03875729's enrollment target sits among peer trials
328 15th of 112 higher than 98 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
RECRUITING · Phase 3
-
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
ACTIVE NOT RECRUITING · Phase 3
-
A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes
ACTIVE NOT RECRUITING · Phase 3
-
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
COMPLETED · Phase 3
-
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
COMPLETED · Phase 3
-
Pediatric Diabetics Type 1 Using InsuPatch
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05156983 · 328 participants · Phase 3
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
- NCT05380401 · 328 participants · NA
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
- NCT05548413 · 328 participants · NA
Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
- NCT06393725 · 328 participants · NA
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI