Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp. to Marketed Glucagon

What Was Tested

This registered phase 2 trial tested Glucagon.

It had two arms (groups): ZP4207 (experimental) and GlucaGen (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 81 actual participants took part.

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

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

Examples of who could join: Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient). Male and female patients with T1D for at least one year, as defined by the American Diabetes Association. Having been treated with insulin for T1D for at least 1 year. Expected stable insulin treatment during participation in trial and 3 month prior to the screening visit. Age between 18 and 50 years, both inclusive.

The full record lists 8 inclusion and 21 exclusion criteria; among the exclusions: previously treated with zp4207; known or suspected allergy to trial product(s) or related products; previous participation (randomization) in this trial.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2016-01 with completion listed for 2016-06.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PD endpoint: Plasma glucose profiles 0-360 min above baseline (Area under the effect curve 0-360 min) (time frame: During visit 2 and 3 (0-360min)). PD endpoint: Time to peak plasma glucose concentration (tmax) (time frame: During visit 2 and 3 (0-360min)). PK endpoint: Plasma ZP4207 and glucagon profiles 0-360 min (time frame: During visit 2 and 3 (0-360min)).

It also tracked 15 secondary outcomes, for example PK endpoints: Baseline adjusted glucagon profiles 0-360 min, PK endpoints: AUC0-inf for plasma ZP4207 concentration, Exploratory endpoint: Insulin concentrations, Exploratory endpoint: Changes in hypoglycaemic symptom scores from 0-30 minutes, Safety and Tolerability: Number of participants with adverse events and Safety and Tolerability: Changes or findings from baseline in physical examination.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 81 people.

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.