Compared with placebo, verapamil partially preserved stimulated C-peptide secretion among children and adolescents with newly diagnosed type 1 diabetes at 52 weeks, a study shows. “An initial improvement in stimulated C-peptide secretion was observed in both groups, but the verapamil group experienced a longer period of stability compared with the placebo group before C-peptide levels began to decline,” the authors write. “In view of the favorable safety profile compared with immunosuppressive agents, once-daily oral administration, and low cost, initiation of verapamil therapy could be considered for patients with newly diagnosed type 1 diabetes.”
The double-blind, randomized clinical trial included 98 children and adolescents aged 7 to 17 years with newly diagnosed type 1 diabetes weighing 30 kg or more at 6 centers in the U.S. A factorial design was used for testing the effects of verapamil versus placebo and intensive versus standard diabetes care.
Based on a primary outcome of the area under the curve values for C-peptide level stimulated by a mixed-meal tolerance test at 52 weeks from diagnosis of type 1 diabetes, the authors found: “Among 88 participants (mean age, 12.7 [SD, 2.4] years; 36 were female [41%]; and the mean time from diagnosis to randomization was 24 [SD, 4] days), 83 (94%) completed the trial. In the verapamil group, the mean C-peptide area under the curve was 0.66 pmol/mL at baseline and 0.65 pmol/mL at 52 weeks compared with 0.60 pmol/mL at baseline and 0.44 pmol/mL at 52 weeks in the placebo group (adjusted between-group difference, 0.14 pmol/mL [95% CI, 0.01 to 0.27 pmol/mL]; P = .04). This equates to a 30% higher C-peptide level at 52 weeks with verapamil. The percentage of participants with a 52-week peak C-peptide level of 0.2 pmol/mL or greater was 95% (41 of 43 participants) in the verapamil group vs 71% (27 of 38 participants) in the placebo group. At 52 weeks, hemoglobin A1c was 6.6% in the verapamil group vs 6.9% in the placebo group (adjusted between-group difference, −0.3% [95% CI, −1.0% to 0.4%]). Eight participants (17%) in the verapamil group and 8 participants (20%) in the placebo group had a nonserious adverse event considered to be related to treatment.”
Editorial: “The demonstration of safety and partial preservation of C-peptide secretion in patients with recent-onset type 1 diabetes supports investigation of verapamil in combination with other effective agents during the earlier stages of type 1 diabetes before insulin dependence develops,” writes an editorialist. “For the newly diagnosed child or adult, the use of automated insulin delivery to achieve optimal glycemia is irrefutably important for well-being and the prevention of vascular complications. However, there is no additional benefit on the production of endogenous insulin. Which combination of beta cell–preserving therapy and automated insulin delivery systems will ultimately promote the best long-term outcomes for an individual is another central question.”