Registry for Stage 2 Type 1 Diabetes
About this study
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.
- Condition
- Type 1 Diabetes
- Tested
- TZIELD (teplizumab-mzwv)
- Sponsor
- Sanofi
Who can join
- Age
- Not specified
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 12
- Study condition: Type 1 Diabetes
- 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
Exclusion 4
- 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.
Where
37 sites, 37 recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400028
Ann Arbor, Michigan, United States
University of Colorado Hospital- Site Number : 8400026
Aurora, Colorado, United States
Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040
Austin, Texas, United States
Johns Hopkins School of Medicine- Site Number : 8400031
Baltimore, Maryland, United States
AM Diabetes & Endocrinology Center- Site Number : 8400012
Bartlett, Tennessee, United States
Women & Children's Hospital of Buffalo- Site Number : 8400018
Buffalo, New York, United States
and 31 more sites on ClinicalTrials.gov
Contact
-
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610 Contact-US@sanofi.com
Potential match only. Final eligibility is determined by the study team.