Teplizumab vs ATG for Stage 3 Type 1 Diabetes

Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG

Recruiting Phase 2 Interventional Study
Type 1 Diabetes Mellitus
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
4 – 34
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Who this trial is looking for

This trial is looking for people aged 4 to 34 who have early signs of Type 1 diabetes. Participants will receive either two infusions of ATG or 14 infusions of teplizumab and will be followed for up to 9 years.

Are You a Good Fit for This Trial?
Rules you out Stage 3 Type 1 diabetes

You may be able to join if

  • I am between 4 and 34 years old.
  • I have at least two diabetes-related autoantibodies.
  • I have been tested and meet the criteria for stage 2 Type 1 diabetes.
  • I am willing to provide informed consent.
  • If I am under 18, my parent or guardian can provide consent.
  • I have no active CMV or EBV infection.
  • I live near the infusion site.
  • I can avoid pregnancy or get pregnancy tests if I am female.

You may not be able to join if

  • I have an immune system problem.
  • I have signs of any infection right now.
  • I am pregnant or breastfeeding.
  • I have uncontrolled autoimmune diseases.
  • I have a serious problem with my blood counts.
  • I have had certain infections like TB.
  • I have liver or kidney dysfunction.
  • I have a history of malignancies other than skin cancer.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \<18 years of age. * Aged ≥4 to \<35 years * A history of at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) p…
Contacts

Melissa Parker

813-396-9378

melissa.parker@epi.usf.edu

CONTACT