Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers

What Was Tested

The trial (phase 1) is built around Glucagon.

It had two arms (groups): 1 (active comparator) and 2 (experimental).

Glucagen.

Mayne Glucagon.

The registry classes the interventions as drug.

More on the Plan

It primarily functions as a counter-regulatory hormone by opposing the actions of insulin to maintain blood glucose levels.

Mayne Glucagon for Injection has been developed as an alternative to currently marketed products.

Mayne has developed a product, Glucagon for Injection, which is an alternative to currently marketed products.

The only difference is the source of the active ingredient.

Who Took Part

28 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: Healthy Male or female aged 18-50 years inclusive. Non-smokers or ex-smokers who have not smoked with in the previous 3 months. Written informed consent given. Willing and able to comply with the requirements of the protocol and available for the planned duration of the study.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: positive pregnancy test or lactation; participation in any other clinical study using an investigational product or device within the previous 12 weeks; positive human immunodeficiency virus (hiv), hepatitis b or c test.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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.

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 2007-08 with completion listed for 2007-10.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 28 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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