Anti-thymocyte Globulin with Verapamil for Type 1 Diabetes

Precision Administration of Anti-thymocyte Globulin With or Without Verapamil

Recruiting Phase 2 Interventional Study
Type 1 Diabetes
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
6 – 35
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of Florida · Other
Who this trial is looking for

This trial is looking for young people with type 1 diabetes who have been diagnosed for less than 100 days. Participants will receive a treatment that may help their insulin production and will need to follow specific health management during the study.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 6 and 35 years old.
  • I have been diagnosed with type 1 diabetes for less than 100 days.
  • I can give consent or my parent/guardian can provide it for me.
  • I have at least one islet cell autoantibody.
  • I have C-peptide levels of 0.2 pmol/ml or higher.
  • I have not had a live vaccine in the last 6 weeks.
  • I am willing to receive a killed influenza vaccine before starting.
  • I can manage my diabetes intensively.

You may not be able to join if

  • I have a significant immune deficiency.
  • I have active signs of infection right now.
  • I am pregnant or breastfeeding.
  • I use other immunosuppressive medications.
  • I have a history of HIV, Hepatitis B, or Hepatitis C.
  • I have significant kidney or liver issues.
  • I have had a live vaccine in the last 6 weeks.
  • I have an allergy to ATG or Verapamil.

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
T cell directed therapy, anti-thymocyte globulin (ATG), in low doses, has been shown to lower HbA1c and preserve endogenous insulin production (measured by C-peptide) in individuals with recently diagnosed type 1 diabetes (T1D). However, not all individuals who received ATG responded to the therapy (i.e., non-responders). Additionally, use of ATG alone does not address inherent beta cell stress. A…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Must be \>= 6 years \<= 35 2. Must have a diagnosis of T1D for less than 100 days at randomization 3. Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is \<18 years of age 4. Positive for at least one islet cell au…
Contacts

Jennifer L Hosford, MPH

352-294-5760

jennifer.hosford@peds.ufl.edu

CONTACT