Precision Administration of Anti-thymocyte Globulin With or Without Verapamil in Adolescents and Young Adults With Type 1 Diabetes

NCT06455319 Phase 2 RECRUITING

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.

Details

Lead sponsor	University of Florida
Phase	Phase 2
Status	RECRUITING
Enrolment	60
Start date	2025-11-12
Completion	2030-08

Conditions

• Type 1 Diabetes

Interventions

• Anti-thymocyte globulin (ATG)
• verapamil extended release capsule
• Placebo

Primary outcomes

• AUC C-peptide between ATG and placebo values — 12 Months
  mean difference between ATG and placebo values of the 2-hr mixed meal tolerance test (MMTT)-stimulated area under the curve (AUC) C-peptide at 12 months
• Change in 2-hr MMTT AUC C-peptide — 6 months
  mean difference between the change in 2-hr MMTT stimulated AUC C-peptide

Countries

United States