A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D

What Was Tested

This registered phase 3 trial tested Glucagon.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Each child will be dosed after the safety assessment of the preceding child has been completed and assessed by the Trial Safety Group.

The primary endpoint of the trial is plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous glucose.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to people of any sex aged up to 5 years.

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

Examples of who could join: Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump or MDI. Body weight greater than 8 kg. Child must be \<6 years of age at the time of screening. Further inclusion criteria apply.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: known or suspected allergy to the imp or related products; any condition that in the investigators opinion may result in diminished hepatic glycogen stores (e.g., prolonged fasting (more than 24 hours) at visit 2; history of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Glucagon study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-05-09 with completion listed for 2024-10-29.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection.

It also tracked 4 secondary outcomes, for example Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection, Number of Participants With Treatment-emergent Adverse Events (TEAEs), Number of Participants Who Received Rescue Intravenous (IV) Glucose Infusion Administration and Time to First IV Glucose Infusion Following Treatment With Dasiglucagon.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Glucagon in 8 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.