A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM

What Was Tested

This registered phase 3 trial tested Glucagon.

It had two arms (groups): Dasiglucagon batch A crossover to dasiglucagon batch B (experimental) and Dasiglucagon batch B crossover to dasiglucagon batch A (experimental).

The registry classes the interventions as drug.

More on the Plan

To avoid bias in the evaluation of clinical assessments, the trial was conducted in a double-blinded manner.

Who Took Part

Enrollment: 92 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: Type 1 diabetes mellitus for at least 1 year according to the diagnostic criteria as defined by the American Diabetes Association.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: history of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening; previous participation in a clinical trial within the dasiglucagon program.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

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, care provider, investigator and outcomes assessor.

It started in 2019-03-26 with completion listed for 2019-07-30.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to plasma glucose recovery.

It also tracked 18 secondary outcomes, for example Plasma glucose changes from baseline, Safety - Adverse events, Safety - Number of rescue infusions, Safety - Time to first rescue infusion and Immunogenicity - Occurrence of anti-drug antibodies.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 92 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.