Disclaimer

The elements presented on this page are not an exhaustive list of information relating to the clinical trial. The inclusion and exclusion criteria have been simplified and should be interpreted by a physician. For more information please visit CTIS website for βeta PRESERVE.

Study design 

  • Study Type: Interventional  (Clinical Trial)
  • Estimated Enrollment: 723 participants
  • Allocation: Randomized (with approximately 33% [1:3] probability of receiving placebo).
  • Purpose: The purpose of this study is to determine the safety and efficacy of teplizumab by assessing glycemic control and/or the need for prandial insulin in participants aged 1 to 25 years with newly diagnosed Type 1 Diabetes, compared with placebo.
  • Official Title: A randomized, double-blind, Phase 3 study to investigate efficacy and safety of teplizumab compared with placebo in participants 1 to 25 years of age with recently diagnosed Stage 3 Type 1 Diabetes (T1D)
  • Duration of Participation: Participants will undergo two 12‑days treatment periods, administered 6 months apart. The total study duration will be up to 84 weeks (approximately 1.5 years).

Criteria

Recruitment for this study is only open to people who meet these criteria.

Highlighted Inclusion:

  • Age: 1-25 years old
  • Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria
  • Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis
  • Participants must be positive for at least one T1D autoantibody at screening:
    • Glutamic acid decarboxylase (GAD-65)
    • Insulinoma Antigen-2 (IA-2)
    • Zinc-transporter 8 (ZnT8) or
    • Insulin (if obtained not later than 14 days after exogenous insulin therapy initiation)
    • Islet cell cytoplasmic autoantibodies (ICAs)
  • Contraceptive use women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Highlight Exclusion:

  • Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes
  • Participant has previously received teplizumab or other anti-CD3 treatment.
  • Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status (including but not limited to oral, inhaled or systemically injected steroids with duration >14 days, adrenocorticotropic hormone, verapamil).
  • Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.
  • Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).
  • History of invasive opportunistic infections or active or latent tuberculosis
  • Participant has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease
  • Any live vaccines within 8 weeks prior to randomization or planned/required administration during treatment or up to 26 weeks after last IMP administration in treatment course
  • Any inactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.
  • Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin

Sponsors and Collaborators

Sanofi

Outcome measures

  • Change from baseline to Week 52 in Glycated hemoglobin (HbA1c)

Or

  • Total number of days without prandial insulin use, from baseline to Week 52

Locations

Interested in more information? You can reach out directly to a site below nearest you.​

Sites Open to Recruitment

Please note that this list will be updated regularly

BELGIUM

CZECH REPUBLIC

  • Fakultni nemocnice v Motole 
    Principal Investigator: Prof. Zdenek Sumník 
    Contact: zdenek.sumnik@lfmotol.cuni.cz

  • Institut klinicke a experimentalni mediciny 
    Principal Investigator: Prof. Martin Haluzik 
    Contact: halm@ikem.cz

  • Vseobecna FakultnI Nemocnice v Praze 
    Principal Investigator: Prof. Martin Prazny 
    Contact: martin.prazny@vfn.cz

FRANCE

GERMANY

GREECE

ITALY

THE NETHERLANDS

POLAND

SPAIN

This does not mean that all INNODIA Clinical Trial Sites will participate in this specific study. 
Some additional sites that are not part of the INNODIA Network may run this study too. 
A complete list of participating sites can be found on CTIS website.