A Study of Nasal Glucagon in Participants With a Common Cold

What Was Tested

This registered phase 1 trial tested Glucagon.

The main purpose of this study is to evaluate the safety of nasal glucagon (NG) in participants with a common cold, some of whom will also take a nasal decongestant.

The study will investigate how the body processes NG and the effect of NG on the body.

The study will last up to 30 days for each participant.

It had three arms (groups): Nasal Glucagon (NG) - Common Cold (experimental), Nasal Glucagon (NG) - Symptom-Free (experimental) and NG - Common Cold+Oxymetazoline (experimental).

Cohort 1 - Nasal Glucagon (NG) administered once in participants with a common cold.

Cohort 1 - NG administered once in participants who have recovered from a common cold.

Cohort 2 - NG administered once in participants with a common cold who are taking oxymetazoline.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Participant with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kilogram per square meter (kg/m²). Light-, non- or ex-smokers.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: presence of any nose piercings; presence or history of type 1 or type 2 diabetes; use of beta-blockers, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before day 1 of the study.

How the Study Was Run

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

The Glucagon group and the comparison group ran side by side rather than switching.

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.

It started in 2013-03 with completion listed for 2013-04.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Number of Participants With One or More Serious Adverse Event(s) (SAEs) (time frame: Baseline up to Study Completion (Day 30)).

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) of Baseline-Adjusted Glucose.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Glucagon in 36 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.