Type 1 Diabetes
Conditions
Brief summary
Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D. The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.
Interventions
DRUGTZIELD (teplizumab-mzwv)
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
TZIELD-Exposed Cohort * Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment: * Day 1: 65 mcg/m2 * Day 2: 125 mcg/m2 * Day 3: 250 mcg/m2 * Day 4: 500 mcg/m2 * Days 5 through 14: 1,030 mcg/m2 per day * Cumulative dose is approximately 11,240 mcg/m2 * Appropriate written informed consent/assent as applicable for the age of the patient TZIELD-Unexposed Cohort * Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD * Appropriate written informed consent/assent as applicable for the age of the patient
Exclusion criteria
* Patients who initiated TZIELD treatment more than 6 months prior to enrollment * Patients who had participated in a previous clinical trial for TZIELD * Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events of special interests (AESI) | Throughout the study, approximately 10 years | Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies |
| Number of serious adverse events (SAE) | Throughout the study, approximately 10 years | — |
| Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy | From start of pregnancy to 12 months post-partum | — |
| Number of maternal pregnancy-related events | From start of pregnancy to 12 months post-partum | — |
| Developmental outcomes of the infant | From birth of infant to 12 months | — |
Countries
United States
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed