Actively Recruiting
Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
Led by University of Florida · Updated on 2025-11-26
60
Participants Needed
2
Research Sites
246 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
U
University of Colorado, Denver
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 calcium channel blocker, verapamil, has demonstrated C-peptide preservation in newly diagnosed T1D. Investigators will identify those mostly likely to respond to ATG using an ex vivo predictive biomarker of response to ATG. In addition, Investigators will use sequential therapies to increase efficacy (ATG followed by verapamil) and explore synergistic mechanisms. This will be assessing with in depth immunophenotyping and quantify biomarkers of beta cell stress, cell death, and abnormal prohormone processing. Finally, novel clinical trial endpoints will be assessed for their ability to predict treatment efficacy earlier than the standard endpoint at 1 year.
CONDITIONS
Official Title
Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 35 years
- Diagnosis of type 1 diabetes for less than 100 days at randomization
- Willing to provide informed consent or have a parent/legal guardian consent if under 18 years
- Positive for at least one islet cell autoantibody (GAD65A, mIAA, IA-2A, ICA, or ZnT8A)
- Stimulated C-peptide level of at least 0.2 pmol/ml during a mixed meal tolerance test at least 21 days after diagnosis
- EBV seronegative participants must be EBV PCR negative and without recent EBV illness
- At least 6 weeks since last live immunization
- Received killed influenza vaccination at least 2 weeks before randomization when available
- Willing to avoid live vaccines during treatment and for 3 months after last study drug dose
- Willing to comply with intensive diabetes management
You will not qualify if you...
- Immunodeficiency or clinically significant chronic lymphopenia
- Active signs or symptoms of acute infection at randomization
- Evidence of prior or current tuberculosis infection
- Pregnant, lactating, or planning pregnancy during the 2-year study
- Use of other immunosuppressive agents or chronic systemic steroids
- Current or past HIV, Hepatitis B, or Hepatitis C infection
- Significant medical issues or abnormal labs that increase risk or interfere with study
- History of malignancies except skin cancer
- Liver dysfunction with AST or ALT over 3 times normal
- Renal dysfunction with creatinine over 1.5 times normal
- Live virus vaccination within last 6 weeks
- Use of non-insulin drugs affecting blood sugar control within 7 days before screening
- Participation in another type 1 diabetes treatment study within 30 days
- Prior treatment with investigational agents to delay beta cell loss in T1D
- Known allergy to ATG, verapamil, or rabbit-derived products
- Any condition that may affect participation or study results as judged by investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
J
Jennifer L Hosford, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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