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| ID | Type | Description | Link |
|---|---|---|---|
| U111-1322-8196 | Other Identifier | ICTRP |
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This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teplizumab | Drug | This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant demographics at teplizumab initiation | Age, sex at birth, height, weight, Body mass index (BMI), body surface area | At Day 1 (first dose of teplizumab) |
| Participants' family history of T1D and autoimmune diseases | First- and second-degree relatives with T1D | At Day 1 (first dose of teplizumab) |
| Presence of T1D susceptibility genes | Genetic risk score | At Day 1 (first dose of teplizumab) |
| Presence of T1D susceptibility genes | Human Leukocyte Antigen (HLA)-haplotype | At Day 1 (first dose of teplizumab) |
| Participants' medical history | Date of stage 1 confirmation, date of dysglycemia confirmation | From 6 months prior to the first dose of teplizumab (teplizumab initiation) (or the earliest date of all data contributing to Stage 2 T1D diagnosis, whichever is earlier) up to medical records abstraction date, approximately 3-4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time from Stage 1 T1D confirmation to Stage 2 confirmation | Only participants with a date of Stage 1 T1D confirmation will be included in this analysis. | From the date of Stage 1 T1D confirmation to date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to a year |
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Inclusion Criteria:
Exclusion Criteria:
• Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Patients diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 60 participants, in approximately 15 sites across at least 5 countries will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | Option 6 | contact-us@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 0560001 | Recruiting | Leuven | 3000 | Belgium | ||
| Investigational Site Number: 2500001 |
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.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C502540 | teplizumab |
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| Time from Stage 2 T1D confirmation to teplizumab initiation | From the date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to a year |
| Assessment of blood glucose test results: Glycated hemoglobin (HbA1c) | At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months) |
| Assessment of blood glucose test results: Fasting Plasma Glucose (FPG) | At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months) |
| Assessment of blood glucose test results: Oral Glucose Tolerance Test (OGTT) | At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months) |
| Assessment of blood glucose test results: Random Plasma Glucose (PG) | At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months) |
| Assessment of blood glucose test results: Post-prandial Glucose (PPG) | At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months) |
| Assessment of blood glucose test results: Continuous glucose monitoring (CGM) | At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months) |
| Assessment of C-peptide test results | At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months) |
| Assessment of autoantibody test results | Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8 | At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months) |
| Proportion of participants who complete teplizumab treatment course | At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months |
| Proportion of participants using insulin during the study period | At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months |
| Proportion of participants using other glucose lowering therapies during the study period | At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months |
| Recruiting |
| Bron |
| 69677 |
| France |
| Investigational Site Number: 2500003 | Recruiting | Paris | 75014 | France |
| Investigational Site Number: 2500002 | Recruiting | Paris | 75015 | France |
| Investigational Site Number: 3800001 | Recruiting | Ancona | 60123 | Italy |
| Investigational Site Number: 3800003 | Recruiting | Palermo | 90127 | Italy |
| Investigational Site Number: 7240001 | Recruiting | Madrid | 28034 | Spain |
| Investigational Site Number: 7240002 | Recruiting | Madrid | 28046 | Spain |
| Investigational Site Number: 7240003 | Recruiting | Zaragoza | 50009 | Spain |
| Investigational Site Number: 8260001 | Recruiting | Birmingham | B4 6NH | United Kingdom |
| Investigational Site Number: 8260002 | Recruiting | London | E1 1BB | United Kingdom |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |