Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SFY18115 | Other Identifier | Sanofi Identifier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teplizumab treated | Experimental | Administration of teplizumab by intravenous infusion for 12 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teplizumab 1 mg/mL | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first dose of study drug administration (Day 1) up to approximately 78 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-dose on Day 364 |
| Number of Participants With Anti-drug Antibodies (ADA) Against Teplizumab |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Diabetes Site Number : 04 | Aurora | Colorado | 80045 | United States | ||
| Clinical Site |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
A total of 6 participants from the TN-10 study (NCT01030861) who developed clinical (stage 3) type 1 diabetes (T1D) after the completion of that study were enrolled in this study. All participants received teplizumab in this study within 1 year of diagnosis of clinical T1D.
The study was conducted in the United States from 26-Feb-2020 to 22-Jan-2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Teplizumab | Participants received teplizumab 9 milligrams per meter square (mg/m^2) via intravenous (IV) infusion as a 12-day course (once daily) split as: Day 1: 106 micrograms (mcg)/m^2, Day 2: 425 mcg/m^2 and Days 3 to 12: 850 mcg/m^2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set included all participants who received at least 1 dose of teplizumab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teplizumab | Participants received teplizumab 9 mg/m^2 via IV infusion as a 12-day course (once daily) split as: Day 1: 106 mcg/m^2, Day 2: 425 mcg/m^2 and Days 3 to 12: 850 mcg/m^2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | The safety analysis set included all participants who received at least 1 dose of teplizumab. | Posted | Count of Participants | Participants | From the first dose of study drug administration (Day 1) up to approximately 78 weeks |
From the first dose of study drug administration (Day 1) up to approximately 78 weeks
The safety analysis set included all participants who received at least 1 dose of teplizumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teplizumab | Participants received teplizumab 9 mg/m^2 via IV infusion as a 12-day course (once daily) split as: Day 1: 106 mcg/m^2, Day 2: 425 mcg/m^2 and Days 3 to 12: 850 mcg/m^2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Completed Suicide | Psychiatric disorders | MedDra 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDra 26.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | #6 | Contact-US@sanofi.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 2, 2019 | Jan 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2024 | Jan 20, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502540 | teplizumab |
Not provided
Not provided
Not provided
Single-arm, multicenter, open-label clinical trial
Not provided
Not provided
Not provided
Not provided
|
Blood samples were collected for the evaluation of ADA against teplizumab. |
| 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. | Week 78 |
| Glycated Hemoglobin (HbA1c) Levels at Week 78 | Blood samples were collected for evaluation of HbA1c. | 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. | 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:
| 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. | From the first dose of study drug administration (Day 1) up to approximately 78 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Yale University School of Medicine Site Number : 01 | New Haven | Connecticut | 06511 | United States |
| Clinical Site | New Haven | Connecticut | 06519 | United States |
| Clinical Site | Gainesville | Florida | 32610 | United States |
| University of Florida Site Number : 02 | Gainesville | Florida | 32610 | United States |
| Clinical Site | Nashville | Tennessee | 37232 | United States |
| Vanderbilt Univerity Medical Center Site Number : 03 | Nashville | Tennessee | 37232 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | 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. | The PK analysis set included all participants in the safety analysis set who had at least 1 eligible PK sample for analysis. Only those participants with data collected on Day 364 are reported. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Pre-dose on Day 364 |
|
|
|
| Secondary | Number of Participants With Anti-drug Antibodies (ADA) Against Teplizumab | Blood samples were collected for the evaluation of ADA against teplizumab. | The immunogenicity analysis set included all participants in the safety analysis set who had at least 1 eligible immunogenicity sample for analysis. | Posted | Count of Participants | Participants | Up to Day 364 |
|
|
|
| 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 | 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. | The safety analysis set included all participants who received at least 1 dose of teplizumab. Only those participants with data collected at Week 78 are reported. | Posted | Mean | Standard Deviation | ln(AUC+1) (picomole/mL) | Week 78 |
|
|
|
| Secondary | Glycated Hemoglobin (HbA1c) Levels at Week 78 | Blood samples were collected for evaluation of HbA1c. | The safety analysis set included all participants who received at least 1 dose of teplizumab. Only those participants with data collected at Week 78 are reported. | Posted | Mean | Standard Deviation | percentage of HbA1c | Week 78 |
|
|
|
| Secondary | 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. | The safety analysis set included all participants who received at least 1 dose of teplizumab. Only those participants with data collected at Week 78 are reported. | Posted | Mean | Standard Deviation | unit/kilogram/day | Week 78 |
|
|
|
| Secondary | 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:
| The safety analysis set included all participants who received at least 1 dose of teplizumab. | Posted | Count of Participants | Participants | From the first dose of study drug administration (Day 1) up to approximately 78 weeks |
|
|
|
| Secondary | 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. | The safety analysis set included all participants who received at least 1 dose of teplizumab. | Posted | Count of Participants | Participants | From the first dose of study drug administration (Day 1) up to approximately 78 weeks |
|
|
|
| 1 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
| Lymphopenia | Blood and lymphatic system disorders | MedDra 26.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDra 26.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDra 26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDra 26.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDra 26.1 | Systematic Assessment |
|
| Chills | General disorders | MedDra 26.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDra 26.1 | Systematic Assessment |
|
| Feeling Hot | General disorders | MedDra 26.1 | Systematic Assessment |
|
| Infusion Site Pruritus | General disorders | MedDra 26.1 | Systematic Assessment |
|
| Pain | General disorders | MedDra 26.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDra 26.1 | Systematic Assessment |
|
| Cytokine Release Syndrome | Immune system disorders | MedDra 26.1 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDra 26.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDra 26.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDra 26.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDra 26.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 26.1 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDra 26.1 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDra 26.1 | Systematic Assessment |
|
| Blood Lactate Dehydrogenase Increased | Investigations | MedDra 26.1 | Systematic Assessment |
|
| Eosinophil Count Increased | Investigations | MedDra 26.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDra 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDra 26.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDra 26.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDra 26.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | Systematic Assessment |
|
| Pharyngeal Erythema | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 26.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDra 26.1 | Systematic Assessment |
|
| Rash Macular | Skin and subcutaneous tissue disorders | MedDra 26.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDra 26.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |