Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

What Was Tested

This registered phase 3 trial tested Glucagon.

It had three arms (groups): dasiglucagon (experimental), placebo (placebo comparator) and GlucaGen® (active comparator).

The registry classes the interventions as drug.

More on the Plan

A minimum of 16 patients were enrolled into each age group, including a minimum of 8 patients in each age group in the dasiglucagon treatment arm.

Who Took Part

The registry lists 42 actual participants took part.

It was open to people of any sex aged from 6 years up to 17 years.

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

Examples of who could join: Following receipt of verbal and written information about the trial, patient, parent(s) or guardian(s) of the patient must provide signed informed consent before any trial-related activity is carried out. Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined by the American Diabetes Association; and receiving daily insulin. At least 6.0 years of age (inclusive) and less than 18.0 years. Body weight ≥20 kg. Female patients must meet one of the following criteria:.

The full record lists 7 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Glucagon.

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

It started in 2018-09-28 with completion listed for 2019-06-28.

It ran at 5 sites in United States (3), Germany (1) and Slovenia (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to Plasma Glucose Recovery.

It also tracked 15 secondary outcomes, for example Plasma Glucose Recovery, Plasma Glucose Changes From Baseline, Administration of Rescue IV Glucose Infusion After IMP Injection and Time to First IV Glucose Infusion After IMP Administration.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 42 people.

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.