ZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon

What Was Tested

In this phase 2 trial, researchers set out to test Glucagon.

It had two arms (groups): ZP4207(dasiglucagon) (experimental) and Glucagon (Native glucagon) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The patients will stay at the clinical site over night between Day 1 and Day 2.

Who Took Part

38 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: Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the patient). Male and female patients with T1DM for at least 1 year, as defined by the American Diabetes Association1. Age between 18 and 64 years, both inclusive. C-peptide negative defined as below the lower limit of quantification. Stable insulin regimen via an insulin infusion pump for at least 1 month prior to screening.

The full record lists 8 inclusion and 29 exclusion criteria; among the exclusions: unable to provide informed consent (e.g., impaired cognition or judgement); receipt of any medicinal product in clinical development within 3 months prior screening; previous exposure to zp4207(dasiglucagon) or previously randomized to 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.

As a double-blind Glucagon study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2016-12-01 with completion listed for 2017-04-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUC 0-240 min (time frame: AUC 0-240 min during all treatment periods (V2-V5)). PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: Cmax. PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: tmax.

It also tracked 23 secondary outcomes, for example PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: MRT, PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: Vz/f,, PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: λz, PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: t½,, PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: CL/f and PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUC 0-30min.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 38 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.