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Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
Sponsor: University of Florida
Summary
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.
Official title: Precision Administration of Anti-thymocyte Globulin With or Without Verapamil in Adolescents and Young Adults With Type 1 Diabetes
Key Details
Gender
All
Age Range
6 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-12
Completion Date
2030-08
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
Anti-thymocyte globulin (ATG)
ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2).
verapamil extended release capsule
Open label administration at 120, 240 or 360 mg daily based on weight and ECG findings
Placebo
I.V. Saline
Locations (2)
Barbara Davis Center for Diabetes
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States