Phase III Study of Verapamil to Preserve Insulin Production in Children Aged 4 to 9 with Recent Type 1 Diabetes

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Verapamil in preserving residual insulin-producing beta cell function in children aged 4 to 9.99 years with recent onset Type 1 diabetes. This Phase III trial focuses on how Verapamil impacts clinical outcomes such as blood glucose control and insulin requirements, addressing a critical need to improve treatment and quality of life for young patients with this serious condition. The trial has two parts Part A involves 6 children receiving open-label Verapamil at doses of 3-6 mgkg per day divided into two oral doses for 12 months, primarily to assess safety. Part B will enroll 30 children randomized equally to receive either Verapamil or placebo twice daily for 12 months under double-blind conditions. Evaluations include mixed Meal Tolerance Tests MMTT and clinical measures like insulin dose, HbA1c, and continuous glucose monitoring over 24 months. Participants undergo baseline assessments including ECG, physical exams, and MMTT. Follow-ups occur at 12 and 24 months to monitor beta cell function, blood sugar control, insulin use, and safety events. The study carefully tracks treatment effects and tolerability, with the total participation duration spanning two years. This approach aims to identify if Verapamil can help maintain insulin secretion with minimal risks in young children newly diagnosed with Type 1 diabetes.

A Phase I/II Trial to Preserve Residual Insulin Secretion in Children With Recent Onset Type 1 Diabetes by Giving Verapamil