Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

What Was Tested

In this phase 1 trial, researchers set out to test Glucagon.

The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.

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

Intramuscular delivery of BIOD-961.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Body Mass Index: 18.5-25.0 kg/m2 inclusive. Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: type 1 or type 2 diabetes mellitus; history of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease; females who are breast feeding, pregnant, or intending to become pregnant during the study.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Glucagon, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-11 with completion listed for 2015-03.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glucagon maximal concentration and area under curve. Glucose maximal concentration and area under curve.

It also tracked 4 secondary outcomes, for example Time to maximal glucagon concentration, Time to maximal glucose concentration, Maximal glucose excursion and Area under the glucose time curve from 0 to return to baseline after blood glucose peaked.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 15 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.