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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1317-7939 | Other Identifier | ICTRP |
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This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab 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 |
|---|---|---|
| Time from teplizumab infusion start to the onset of Stage 3 T1D | From start of infusion to maximum of 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who complete teplizumab treatment course | Up to end of infusion, maximum of 5 years | |
| Number of participants with adverse events during the infusion period | Till 6 weeks post last infusion, maximum of 5 years |
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Inclusion Criteria -
(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)
• Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.
Exclusion Criteria -
(Note: Participants enrolled in other observational studies may be included.)
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 1000 participants, in 85 sites across 19 countries will be enrolled over 5 years.
| 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: 8400003 | Recruiting | Atlanta | Georgia | 30318-2538 | United States | |
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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| Number of participants with adverse events of special interest and serious adverse events | From 6 weeks post last infusion through the follow-up, maximum of 10 years |
| Number of participants with T1D-related complications | Including but not limited to the following: diabetic ketoacidosis, severe hypoglycemia, retinopathy, nephropathy, neuropathy, cardiovascular events | From infusion up to end of study, maximum of 10 years |
| Glycemic control assessment values | From baseline through follow-up, maximum of 10 years |
| Change from baseline in glycated hemoglobin (HbA1c) | From baseline through follow-up, maximum of 10 years |
| Proportion of participants achieving target HbA1c ≤ 6.5% | From baseline through follow-up, maximum of 10 years |
| Proportion of participants using home glycemic control assessments (eg, SMBG, CGM) | From baseline through follow-up, maximum of 10 years |
| Proportion of participants using glycemic control assessments in-clinic (eg, OGTT, FPG, MMTT, RPG) | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in Time in range (TIR) (70 to 180 mg/dL [3.9 to 10 mmol/L]) | CGM reading 70 to 180 mg/dL [3.9 to 10 mmol/L] | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in Time in tight range (TITR) (70 to 140 mg/dL [3.9 to 7.8 mmol/L]) | CGM reading 70 to 140 mg/dL [3.9 to 7.8 mmol/L] | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in Time above tight range (TATR): >140 mg/dL (>7.8 mmol/L) | CGM reading >140 mg/dL (>7.8 mmol/L) | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in Time above range (TAR): >180 mg/dL (>10 mmol/L) | CGM reading >180 mg/dL (>10 mmol/L) | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in Time above range (TAR): >250 mg/dL (>13.9 mmol/L) | CGM reading >250 mg/dL (>13.9 mmol/L) | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in Time below range (TBR): <70 mg/dL (<3.9 mmol/L) | CGM reading <70 mg/dL (<3.9 mmol/L) | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in Time below range (TBR): <54 mg/dL (<3.0 mmol/L) | CGM reading <54 mg/dL (<3.0 mmol/L) | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in within-day glucose coefficient of variation | From baseline through follow-up, maximum of 10 years |
| Mean change from baseline in between-day glucose coefficient of variation | From baseline through follow-up, maximum of 10 years |
| Proportion of participants using insulin during the study period | Continuous subcutaneous insulin infusion, insulin pump, or pump integrated with an automated insulin delivery system | Up to end of study, maximum of 10 years |
| Proportion of participants using other glucose lowering therapies during the study period | Up to end of study, maximum of 10 years |
| Change in EuroQol 5-Dimensions (EQ-5D) scores in adult and pediatric participants | From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years |
| Change in Hospital Anxiety and Depression Scale (HADS) scores in adult participants | From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years |
| Change in World Health Organization-Five Well-Being Index (WHO-5) scores in pediatric participants | From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years |
| Change in Diabetes Distress Scale (DDS) scores in adult participants | From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years |
| Change in Hypoglycemia Fear Survey-II (HFS-II) scores in adult and pediatric participants | From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years |
| Annualized rate of hospitalizations due to T1D related disease and complications | Up to end of study, maximum of 10 years |
| Annualized rate of emergency room visits related to T1D related disease and complications | Up to end of study, maximum of 10 years |
| Investigative Site Number: 8400004 |
| Recruiting |
| Atlanta |
| Georgia |
| 30329-3102 |
| United States |
| Investigative Site Number: 8400002 | Recruiting | Syosset | New York | 11791 | United States |
| Investigational Site Number: 8400005 | Recruiting | Sandy City | Utah | 84093 | United States |
| Investigative Site Number: 3760003 | Recruiting | Petah Tikva | 4920235 | Israel |
| Investigative Site Number: 3760002 | Recruiting | Ramat Gan | 52621 | Israel |
| Investigational Site Number: 3760001 | Recruiting | Ramat Gan | 5265601 | Israel |
| Investigative Site Number: 7840001 | Recruiting | Abu Dhabi | United Arab Emirates |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |