A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes

What Was Tested

The trial (phase 1) is built around Glucagon.

This study will investigate how the body processes nasal glucagon and the effect of nasal glucagon on the body.

After an 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, the study drug will be delivered into the participant's nostril(s) (intranasally) once or twice in each of four study periods.

The study is open to adults with type 1 or type 2 diabetes and is expected to last about 50 days for each participant.

It had four arms (groups): Treatment 1 (experimental), Treatment 2 (experimental), Treatment 3 (experimental) and Treatment 4 (experimental).

The registry classes the interventions as drug.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: A female participant must meet one of the following criteria:. Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses). Participants with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m². Light-, non- or ex-smokers.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: females who are pregnant, actively attempting to get pregnant, or are lactating; suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases; known presence of rare hereditary problems of galactose and /or lactose intolerance.

How the Study Was Run

Design: randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

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 2014-06 with completion listed for 2014-06.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: 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.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 12 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Glucagon compound page, all human trials.