A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults

What Was Tested

The trial (phase 1) is built around Glucagon.

The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon (NG).

The study drug was delivered into the participant's nostril (intranasally) or was given as an injection just under the skin (subcutaneously) once in each of four study periods.

The study lasted about 23 days for each participant.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Body mass index (BMI) greater than or equal to 20.00 and below or equal to 28.00 kg/m². Light-, non- or ex-smokers.

How the Study Was Run

Design: randomized, crossover and single-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.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2011-10 with completion listed for 2011-10.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Number of Participants With One or More Serious Adverse Event(s) (SAEs) (time frame: Baseline through Study Completion (Day 23)).

It also tracked 7 secondary outcomes, for example PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon, PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon, PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon, PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose and PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 16 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.