A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

What Was Tested

This registered phase 3 trial tested Glucagon.

Additionally to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.

It had three arms (groups): Dasiglucagon (experimental), Placebo (placebo comparator) and GlucaGen® (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 170 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Female or male subjects with type 1 diabetes mellitus (T1DM) for at least 1 year, diagnostic criteria as defined by the American Diabetes Association.

The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: previously treated with dasiglucagon (previously referred to as zp4207); known or suspected allergy to trial product(s) or related products; females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating.

How the Study Was Run

It was run as a randomized, parallel-group 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2017-12-07 with completion listed for 2018-04-27.

It ran at 5 sites in Germany (2), United States (1), Austria (1) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to Plasma Glucose Recovery.

It also tracked 11 secondary outcomes, for example Plasma Glucose Recovery, Plasma Glucose Changes From Baseline, Time to Target, Rescue Infusion of IV Glucose During the Hypoglycemic Clamp Procedure and Time to First Rescue Infusion of IV Glucose.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 170 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.