Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial
Primary result · Mean C-peptide AUCResult — go to the resultAdjusted between-group difference 0.14 pmol/mL 95% CI 0.01–0.27Authors' conclusion
In children and adolescents with newly diagnosed type 1 diabetes, verapamil partially preserved stimulated C-peptide secretion at 52 weeks from diagnosis compared with placebo. Further studies are needed to determine the longitudinal durability of C-peptide improvement and the optimal length of therapy.
Study context
- Population
- Children and adolescents aged 7 to 17 years with newly diagnosed T1D weighing ≥30 kg, 6 US centers; mean age 12.7 (SD 2.4) years, 41% female83 completed
- Participants
- 88 children
- Comparison
- Once-daily oral verapamil vs placebo
- Verapamiln = 47
- Placebon = 41reference
- Primary endpoint
- Area under the curve values for C-peptide level stimulated by a mixed-meal tolerance test
- Follow-up
- 52 weeks from diagnosis
Methodological detailsdouble-blind, factorial, multicentre
- Double-blind
- Factorial
- Multicentre
Primary result
Mean C-peptide AUC · 52 weeks
Adjusted between-group difference
0.14 pmol/mL
95% CI 0.01–0.27
P = 0.04
By group
Verapamilvs Placebo
adjusted between-group difference 0.14 pmol/mL (95% CI 0.01–0.27); P = 0.04
As reported in the abstract
- Higher C-peptide level at 52 weeks with verapamil
- 30%
Further findings
Mean C-peptide AUC at baseline
Peak C-peptide ≥0.2 pmol/mL · 52 weeks
%
| Outcome | Verapamil | Placebo | Adjusted between-group difference (%) (95% CI) | |
|---|---|---|---|---|
| HbA1c · 52 weeks | 6.6 | 6.9 | −0.3 (−1.0% to 0.4%) | |
| −1.5−1−0.500.5Difference, % (linear scale) |
- Peak C-peptide ≥0.2 pmol/mL: 41 of 43 vs 27 of 38 participants
Safety
Nonserious treatment-related adverse event
Original publication
Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial. JAMA. Published 28 March 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →