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
Los Angeles 5368361, California 5332921 90095
San Francisco 5391959, California 5332921 94158
Aurora 5412347, Colorado 5417618 80045
New Haven 4839366, Connecticut 4831725 06510
Jacksonville 4160021, Florida 4155751 32207
Chicago 4887398, Illinois 4896861 60637
Indianapolis 4259418, Indiana 4921868 46202
Louisville 4299276, Kentucky 6254925 40202
Baltimore 4347778, Maryland 4361885 21205
Ann Arbor 4984247, Michigan 5001836 48109
Farmington Hills 4992523, Michigan 5001836 48334
Grand Rapids 4994358, Michigan 5001836 49503
Rochester 5043473, Minnesota 5037779 55902
Kansas City 4393217, Missouri 4398678 64108
Buffalo 5110629, New York 5128638 14222
Manhasset 5125766, New York 5128638 11030
Staten Island 5139568, New York 5128638 10306
Syracuse 5140405, New York 5128638 13210
Chapel Hill 4460162, North Carolina 4482348 27514
Cincinnati 4508722, Ohio 5165418 45229
Cleveland 5150529, Ohio 5165418 44106
Columbus 4509177, Ohio 5165418 31901
Columbus 4509177, Ohio 5165418 43210
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Bartlett 4604183, Tennessee 4662168 38133
Nashville 4644585, Tennessee 4662168 37232-5536
Dallas 4684888, Texas 4736286 75235
Houston 4699066, Texas 4736286 77030
Salt Lake City 5780993, Utah 5549030 84132-0001
Morgantown 4815352, West Virginia 4826850 26505
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