Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Glucagon.

In addition, the safety and tolerability of glucagon given nasally was evaluated.

It had two arms (groups): Nasal Glucagon (NG) (experimental) and Intramuscular (IM) Glucagon (active comparator).

The registry classes the interventions as drug.

More on the Plan

After a wash-out period of 7 days or more, participants 12 to less than 17 years of age returned to the clinic and the procedure was repeated with each participant crossed over to the other treatment.

Who Took Part

Enrollment: 48 actual participants took part.

It was open to people of any sex aged from 4 years up to 16 years.

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

Examples of who could join: History of type 1 diabetes and receiving daily insulin therapy from the time of diagnosis for at least 12 months. At least 4 years of age and less than 17 years. Females must have met one of the following criteria:. Of childbearing potential but agreed to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from screening until study completion). Of non-childbearing potential, defined as a female who had a hysterectomy or tubal ligation, was clinically considered infertile or had not yet reached menarche.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: females who were pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or were lactating; history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs; history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

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 2013-11 with completion listed for 2015-01.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum Change From Baseline Concentration (Cmax) of Glucagon. Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon. Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon.

It also tracked 3 secondary outcomes, for example Nasal and Non-nasal Effects/Symptoms.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Glucagon in 48 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.