Study of Anti-thymocyte Globulin and Verapamil for Type 1 Diabetes
This study is testing if a low dose of anti-thymocyte globulin (ATG), a drug that targets T cells (a type of immune cell), can help people with newly diagnosed Type 1 Diabetes (T1D) preserve their body's own insulin production. It also explores if adding verapamil, a calcium channel blocker, can further improve results. You might be eligible if you are between 6 and 35 years old, have been diagnosed with T1D for less than 100 days, and have certain antibodies (like GAD65A) in your blood. The study will measure success by looking at how much C-peptide (a marker of insulin production) your body makes after 6 and 12 months. The current recruitment status is unclear.
- Study design
- This is a Phase 2 study that will randomly assign 60 participants to receive either low-dose ATG or a placebo (inactive substance) in a blinded way for one year. After this, participants will be re-randomized to receive verapamil or not for another year in an open-label (everyone knows what they are getting) extension.
- What's involved
- Participants will be involved in the study for a total of two years, with measurements of C-peptide at 6 and 12 months, and further mechanistic studies in the second year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months for the primary endpoints, and then for an additional year in an extension phase.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Laura M Jacobsen, MD · PRINCIPAL_INVESTIGATOR · University of Florida
Who to contact
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What this trial measures
- AUC C-peptide between ATG and placebo values12 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-peptide6 months
mean difference between the change in 2-hr MMTT stimulated AUC C-peptide