A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus

What Was Tested

In this phase 3 trial, researchers set out to test Glucagon.

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

The registry classes the interventions as drug.

More on the Plan

Patients with previous exogenic glucagon exposure were not excluded from the trial, but the information on previous glucagon administration was recorded to enable subgroup analyses.

It was expected that 112 patients in total would be randomly assigned to treatment groups and treated.

A total of 90 patients were expected to complete the trial (45 in each treatment arm).

To qualify as completed, the patient had to be dosed according to the procedure described in the protocol and to have blood drawn for the antidrug antibody analyses as scheduled.

Who Took Part

Enrollment: 112 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 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). Availability for the entire trial period. Age between 18 and 70 years, both inclusive. Male or female patients with T1DM for at least 1 year. Diagnostic criteria as defined by the American Diabetes Association.

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: previous administration of dasiglucagon (previously referred to as zp4207); known or suspected allergy to trial medication(s) or related products; history of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

The Glucagon group and the comparison group ran side by side rather than switching.

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 2017-06-28 with completion listed for 2018-02-13.

It ran at 7 sites in Canada (3), United States (2), Austria (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Patients With ADA.

It also tracked 16 secondary outcomes, for example Percentage of Patients With Treatment-induced ADA, Percentage of Patients With Treatment-boosted ADA, Characterization of ADA Response - Neutralizing Activity, Characterization of ADA Response - Titer of Neutralizing Activity, Characterization of ADA Response - Cross-reactivity and Characterization of ADA Response - Timing.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 112 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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