A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

Summary

The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.

Timeline

Start

2019-02-07

Primary completion

2020-08-31

Completion

2020-10-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Standard of Care + Dasiglucagon vs Standard of Care Only; p = 0.5028; Event rate ratio 0.85 (95% CI 0.54 to 1.36); Negative binomial regression NCT03777176 ↗

Drugs

Indications