Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration

What Was Tested

This registered phase 1 trial tested Glucagon.

Furthermore, the trial aims to assess the potential effect of dasiglucagon on corrected QT interval (QTc) prolongation via a concentrationresponse analysis.

It had three arms (groups): IV Dasiglucagon (experimental), one (experimental) and IV Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Hypoglycemia in patients with diabetes is defined as episodes of an abnormally low plasma glucose concentration.

Hypoglycemia is a common, unpredictable, and potentially dangerous side effect of treatment of diabetes mellitus, especially with insulin or sulfonylureas.

Dasiglucagon (ZP4207) is a stable peptide analog of human glucagon, available in a ready-to-use liquid formulation.

Dasiglucagon is in development for the treatment of severe hypoglycemia in patients with diabetes mellitus.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: 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 subject). Healthy female or male subjects aged between 18 and 45 years, both inclusive. Body weight between 60 and 90 kg, both inclusive. Subjects in good health according to age (medical history, physical examination, vital signs, and laboratory assessments), as judged by the investigator. Systolic Blood Pressure (SBP) ≥90 mmHg, ≤140 mmHg and Diastolic Blood Pressure (DBP) ≤90 mmHg measured after at least 5 min rest in supine position.

The full record lists 22 inclusion and 23 exclusion criteria; among the exclusions: previous participation in any trial with dasiglucagon. participation defined as enrolled into trial; known or suspected hypersensitivity to trial product(s) or related products; history of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction.

How the Study Was Run

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

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2018-11-07 with completion listed for 2019-06-24.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: day 1, day 2, day 28).

It also tracked 9 secondary outcomes, for example Clinical assessment of local tolerability at injection site by physical examination, Occurrence of anti-drug antibodies (ADA), Plasma dasiglucagon profiles following IV administration, Area Under the Curve (AUC), Plasma dasiglucagon profiles following SC administration, Area Under the Curve (AUC), Change-from-baseline in ECG for QTcF and Change-from-baseline in ECG for heart rate (HR).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 60 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.