Registry for Stage 2 Type 1 Diabetes
Purpose
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
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| TZIELD group | Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment |
|
| Comparator group | Patients not planned to be treated |
|
Recruiting Locations
San Francisco, California 94158
Aurora, Colorado 80045
New Haven, Connecticut 06510
Jacksonville, Florida 32207
Chicago, Illinois 60637
Indianapolis, Indiana 46202
Louisville, Kentucky 40202
Baltimore, Maryland 21205
Ann Arbor, Michigan 48109
Grand Rapids, Michigan 49503
Rochester, Minnesota 55902
Kansas City, Missouri 64108
Buffalo, New York 14222
Manhasset, New York 11030
Staten Island, New York 10306
Syracuse, New York 13210
Chapel Hill, North Carolina 27514
Cincinnati, Ohio 45229
Cleveland, Ohio 44106
Columbus, Ohio 31901
Columbus, Ohio 43210
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Bartlett, Tennessee 38133
Nashville, Tennessee 37232
Dallas, Texas 75390
Houston, Texas 77030
Salt Lake City, Utah 84132-0001
More Details
- NCT ID
- NCT06481904
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
Contact-US@sanofi.com