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Phase III

Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT)

  • Study HIC#:2000025596
  • Last Updated:01/01/0001

Brief 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.

  • Age8 years - 17 years
  • GenderBoth

Contact Us

For more information about this study, including how to volunteer, contact:

Michele Alguard

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Trial Purpose and Description

The purpose of this study is to determine whether teplizumab slows the loss of B cells and preserves B cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..

Eligibility Criteria

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.

Principal Investigator

For more information about this study, including how to volunteer, contact: