Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this study is to determine whether teplizumab slows the loss of β cells and
preserves β cell function in children and adolescent 8-17 years old who have been diagnosed
with T1D in the previous 6 weeks..
Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Diabetes (Type I)
Enrollment Eligibility
Inclusion Criteria:
1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study
drug administration.
2. Has received a diagnosis of T1D according to the criteria from the American Diabetes
Association.
3. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the
formal T1D diagnosis.
4. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test
(MMTT) at screening.
5. Has a positive result on testing for T1D-related autoantibodies.
Exclusion Criteria:
1. Has any autoimmune disease other than T1D with the exception of stable thyroid or
celiac disease.
2. Has an active infection and/or fever.
3. Has a history of or serologic evidence at screening of current or past infection with
human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus
(HCV).
4. An individual who has a medical, psychological or social condition that, in the
opinion of the Principal Investigator, would interfere with safe and proper completion
of the trial.