A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM

What Was Tested

This registered phase 1 trial tested Glucagon.

This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM).

It had three arms (groups): BioChaperone® glucagon formulation 1 (experimental), BioChaperone® glucagon formulation 2 (experimental) and GlucaGen® HypoKit® (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 27 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female patients aged between 18 and 64 years (both inclusive). Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit. Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit. Stable insulin treatment at least 3 months prior to the screening visit. Body mass index (BMI) \< 30.0 kg/m2.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: type 2 diabetes mellitus; previous participation in this trial. participation is defined as being randomised; receipt of any medicinal product in clinical development within 60 days prior to this trial.

How the Study Was Run

The set-up was 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.

Blinding on both sides kept the participants and researchers unaware of who received Glucagon.

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

It started in 2017-06-06 with completion listed for 2017-09-04.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clinical safety laboratory (time frame: Up to 10 weeks). Physical examination (time frame: Up to 10 weeks). ECG parameters (time frame: Up to 10 weeks).

It also tracked 7 secondary outcomes, for example AUCPK 0-30min, AUC PK 0-4h, ΔAUCPG 0-30min, ΔAUCPG 0-4h and ΔPG 30min.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 27 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.