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

What Was Tested

This registered phase 2, phase 3 trial tested Glucagon.

It had two arms (groups): dasiglucagon first then placebo (experimental) and placebo first then dasiglucagon (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 7 Days up to 364 Days.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: CHI diagnosis established based on the following:. Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or. Male or female, age ≥7 days and \<12 months at screening. Body weight of ≥2.0 kg (4.4 lbs.).

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: is suspected of having a transient form of chi (e.g., transient hyperinsulinism due to maternal diabetes or perinatal stress); was born preterm below 34 weeks of gestational age; presence of hypertension or hypotension, including circulatory instability requiring supportive medication or presence of pheochromocytoma.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

As a double-blind Glucagon study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-06-19 with completion listed for 2022-02-17.

It ran at 6 sites in United States (2), Germany (2), Israel (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Intravenous Glucose Infusion Rate (time frame: Hours 36-48 after initiation of trial drug (Part 1)).

It also tracked 21 secondary outcomes, for example Carbohydrates Administered, Mean Intravenous Glucose Infusion Rate, Time to Complete Weaning Off Intravenous Glucose, Hypoglycemia Event Rate in Part 2, Time to Actual Hospital Discharge and Time to Pancreatic Surgery.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Glucagon in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glucagon compound page, all human trials.