Previous preclinical data has shown that verapamil, a calcium-channel blocker, reduces the expression of thioredoxin-interacting protein, which promotes the survival of insulin-producing beta cells and reverses diabetes in murine models. For this study, researchers conducted a randomized, double-blind, placebo-controlled Phase 2 trial (N=24) to assess the efficacy and safety of adding oral verapamil for 12 months to a standard insulin regimen in adults with recent-onset type 1 diabetes (age range: 18 to 45 years). Study patients were diagnosed with type 1 diabetes within 3 months of trial start and continued with their insulin pump throughout the study. In each group, total daily dose of insulin, amount of insulin produced, percent change in insulin production, and HbA1c levels were monitored.
Results showed that verapamil was associated with an improved mixed-meal-stimulated C-peptide area under the curve at months 3 and 12, as compared to placebo (primary endpoint). In addition, adding verapamil was associated with reduced insulin requirements and hypoglycemic episodes, and on-target glycemic control. In general, verapamil was well-tolerated vs placebo.
“Although this is a smaller sample group, our trial results give us promise that subjects with Type 1 diabetes have therapy options and that we are nearing a more effective way to deal with this disease,” stated co-principal investigator, Fernando Ovalle, MD, director of University of Alabama at Birmingham Comprehensive Diabetes Clinic.
Based on the findings, adding once-daily oral verapamil may be an effective and “novel approach to promote endogenous beta cell function and reduce insulin requirements and hypoglycemic episodes in adult individuals with recent-onset [type 1 diabetes],” the authors concluded. Additional studies are needed to better understand the effect of verapamil in pediatric patients with type 1 diabetes and in those who have had type 1 diabetes for longer than 3 months.
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