Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

Summary

The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.

Timeline

Start

2020-06-19

Primary completion

2022-02-17

Completion

2022-03-07

Outcome

Met primary endpoint

registry analysis (superiority test); Dasiglucagon vs Placebo; p = 0.0037; Difference in LS means -5.21 (95% CI -8.29 to -2.13); Mixed Models Analysis NCT04172441 ↗

Drugs

Indications