A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes

What Was Tested

The trial (phase 1) is built around Glucagon.

The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years.

Blood tests will be performed to check how much nasal glucagon gets into the bloodstream.

Blood sugar will also be measured to understand the effect of the drug on blood sugar levels.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 7 actual participants took part.

It was open to people of any sex aged from 1 Year up to 4 years.

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

Examples of who could join: Have a Type 1 Diabetes diagnosis for at least 6 months. Have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening. Have sufficient venous access for collection of blood samples. Have good general health, apart from their Type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: have a presence or history of glucagon hypersensitivity; have a history of pheochromocytoma; have a history of epilepsy or seizure disorder.

How the Study Was Run

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

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2022-03-24 with completion listed for 2023-11-05.

It ran at 8 sites in United States (8).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline to Day 9).

It also tracked 5 secondary outcomes, for example PD: Absolute BGmax of Nasal Glucagon, PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon and PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Glucagon in 7 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.