Phase 2
Completed N=6
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT04270942 ↗
Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Feb 2025
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events of Special Interest (TEAESIs) and Treatment-emergent Serious Adverse Events (TESAEs) — 6; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events of Special Interest (TEAESIs) and Treatment-emergent Serious Adverse Events (TESAEs) |
6; 0; 1 | — |
| SECONDARY Serum Concentration Immediately Prior to Administration of the Next Dose (Ctrough) of Teplizumab at Day 364 |
NA | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADA) Against Teplizumab |
6 | — |
| SECONDARY Area Under the Time-Versus-Concentration Curve (AUC) of C-peptide After a 4-hour (4h) Mixed Meal Tolerance Test (MMTT) at Week 78 |
0.549 | — |
| SECONDARY Glycated Hemoglobin (HbA1c) Levels at Week 78 |
8.50 | — |
| SECONDARY Average Daily Use of Exogenous Insulin at Week 78 |
0.54 | — |
| SECONDARY Number of Participants With Severe Hypoglycemic Episodes |
— | — |
| SECONDARY Number of Participants With Change in Cluster of Differentiation (CD)8+ TIGIT+ KLRG1+ T Cells |
4 | — |
Eligibility Criteria
Inclusion Criteria
- Previous participant in the TN-10 study
- 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).
- Participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
- Participant was willing to forego other forms of experimental treatment during the entire study.
- Participant and/or guardian had given informed consent and assent as applicable.
Exclusion Criteria
- Had an active infection and/or fever.
- 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).
- 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.
Data sourced from ClinicalTrials.gov (NCT04270942). 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. Informational only — not medical advice.