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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Solution for infusion administered as IV infusion (anti-CD3 humanized monoclonal antibody). Cumulative dose: 9 mg/m2. Day 1: 106 μg/m2, Day 2: 425 μg/m2, Days 3-12: 850 μg/m2 daily
Barbara Davis Center for Diabetes Site Number : 04
Aurora, Colorado, United States
Clinical Site
Aurora, Colorado, United States
Yale University School of Medicine Site Number : 01
New Haven, Connecticut, United States
Clinical Site
New Haven, Connecticut, United States
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events of Special Interest (TEAESIs) and Treatment-emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant,temporally associated with use of study dose,whether or not considered related to study dose.AESI was any AE that met any of following:All \>=Grade 3 infections (including all opportunistic infections);acute mononucleosis-like illness;lymphomas or other malignancies;severe hypoglycemic episode;\>=Grade 3 liver function abnormalities, thrombocytopenia, neutropenia or rash;\>= Grade 4 allergic/hypersensitivity reaction (anaphylaxis) or cytokine-release syndrome; lymphocyte count \<500/cubic millimeter for 7 days or longer. An SAE was as any untoward medical occurrence that,at any dose:resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization,resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or any other medically important event.A TEAE was any AE which started during or after the first dose of teplizumab.
Time frame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Serum Concentration Immediately Prior to Administration of the Next Dose (Ctrough) of Teplizumab at Day 364
Blood samples were collected for evaluation of pharmacokinetic (PK) data.
Time frame: Pre-dose on Day 364
Number of Participants With Anti-drug Antibodies (ADA) Against Teplizumab
Blood samples were collected for the evaluation of ADA against teplizumab.
Time frame: Up to Day 364
Area Under the Time-Versus-Concentration Curve (AUC) of C-peptide After a 4-hour (4h) Mixed Meal Tolerance Test (MMTT) at Week 78
The AUC of C-peptide was measured after a 4-hour MMTT as a measure of assessing endogenous insulin production and beta cell function. The AUC was computed using the trapezoidal rule and standardized by the duration of the MMTT test for the analysis.
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Clinical Site
Gainesville, Florida, United States
University of Florida Site Number : 02
Gainesville, Florida, United States
Clinical Site
Nashville, Tennessee, United States
Vanderbilt Univerity Medical Center Site Number : 03
Nashville, Tennessee, United States
Time frame: Week 78
Glycated Hemoglobin (HbA1c) Levels at Week 78
Blood samples were collected for evaluation of HbA1c.
Time frame: Week 78
Average Daily Use of Exogenous Insulin at Week 78
The average daily insulin use was calculated based on participants who had at least 3 days of insulin use recorded in the diary for the Week 78 visit.
Time frame: Week 78
Number of Participants With Severe Hypoglycemic Episodes
The severity of a hypoglycemia event was identified by the Investigator and classified according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 as follows: * Grade 3 hypoglycemia: 30-39 milligram/deciliter (mg/dL) (1.7-2.1 millimole \[mmol\]/L). This is considered severe or medically significant but not immediately life-threatening. Hospitalization or prolongation of hospitalization is likely indicated. It is considered disabling and limits self-care. * Grade 4 hypoglycemia: \<=29 mg/dL (1.6 mmol/L). This is considered life threatening (seizures) with urgent intervention indicated. * Grade 5 hypoglycemia: Hypoglycemia resulting in death. Hypoglycemia \>=Grade 3 was considered as severe hypoglycemia.
Time frame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks
Number of Participants With Change in Cluster of Differentiation (CD)8+ TIGIT+ KLRG1+ T Cells
CD8+ TIGIT+ KLRG1+ T cells were measured using flow cytometry.
Time frame: From the first dose of study drug administration (Day 1) up to approximately 78 weeks