Phase 3
N=328
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03875729 ↗Enrolled (actual)
328
Serious AEs
5.5%
Results posted
Apr 2024
Primary outcome: Primary: Change in C-peptide ln(AUC+1) Standardized by Duration of the Mixed Meal Tolerance Test (MMTT) — -0.2112; -0.0859; -0.2185; -0.0800 pmol/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- teplizumab (Biological); Placebo (Biological)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Provention Bio, Inc.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in C-peptide ln(AUC+1) Standardized by Duration of the Mixed Meal Tolerance Test (MMTT) |
-0.2112; -0.0859; -0.2185; -0.0800 | <0.001 sig |
| SECONDARY Average Daily Exogenous Insulin Use |
0.593; 0.463; 0.613; 0.446 | 0.085 |
| SECONDARY Change in Glycated Hemoglobin (HbA1c) Levels (%) |
-1.89; -1.98; -1.94; -2.07 | 0.606 |
| SECONDARY Time in Range for Glycemia Control |
62.65; 67.36; 61.44; 67.61 | 0.151 |
| SECONDARY Rate of Clinically Important Hypoglycemic Events |
4.24; 4.68; 4.63; 5.04 | 0.634 |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESIs) |
24; 63; 2; 1; 3; 17 | — |
| SECONDARY Teplizumab Serum Concentrations |
7.4271; 70.4769; 250.3928; 636.4390; 305.6569; 25.0317 | — |
| SECONDARY Anti-teplizumab Antibody (ADA) Titers After Treatment Courses |
65.81; 177.22; 817.08; 1040.58; 834.86; 807.26 | — |
| SECONDARY Incidence of Anti-drug Antibodies (ADA) After Treatment Courses |
15; 200; 182; 25; 178; 26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
- Has received a diagnosis of type 1 diabetes (T1D) according to the criteria from the American Diabetes Association.
- Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
- Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
- Has a positive result on testing for T1D-related autoantibodies.
Exclusion Criteria
- Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.
- Has an active infection and/or fever.
- Has 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).
- An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Data sourced from ClinicalTrials.gov (NCT03875729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.