Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents

What Was Tested

The trial (phase 3) is built around Glucagon.

Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at time of enrolment will be selected for inclusion in the study.

The target is to obtain treatment response and user-experience data following use of Nasal Glucagon (LY900018) in treating episodes of hypoglycemia.

It had 1 arm (groups): Nasal Glucagon (experimental).

The registry classes the interventions as drug.

More on the Plan

This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 4 years up to 17 years.

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

Examples of who could join: Availability for the entire study period. C/AWD lives with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia. Male or female C/AWD with a history of type 1 diabetes \>1 year. C/AWD aged of at least 4 years of age but less than 18 years. A female C/AWD must meet one of the following criteria:.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or lactating; presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma; use of daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Glucagon study did not mask who received what.

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

It started in 2015-03 with completion listed for 2015-08.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Assessment of Ease-of-use of Dry-Mist Nasal Glucagon by Completion of Questionnaire by the Caregiver and Percentage of Participants With Adverse Events Through the Nasal Score Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Glucagon in 26 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.