Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes

What Was Tested

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

It had three arms (groups): one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

However, the instability in aqueous solution of currently available glucagon and the need for reconstitution with sterile water immediately prior to administration has limited its clinical role outside emergency settings.

Due to the stability and ready-to-use formulation, dasiglucagon does not hold the limitations known for the currently available glucagon preparations.

Who Took Part

The registry lists 20 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: Age 18-64 years. Duration of T1D ≥ 3 years. Use of CSII or MDI therapy for ≥ 6 months. Current use of Novorapid (change from another fast-acting insulin to Novorapid prior to study initiation is allowed). Regular use of carbohydrate counting in the judgement of the investigator.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: history of allergy or intolerance to glucagon or glucagon-like products; patients with pheochromocytoma; females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection).

How the Study Was Run

It was run as a randomized, crossover and single-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.

In this single-blind Glucagon study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2020-07-02 with completion listed for 2021-01-04.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Difference between study visits in time (min) in hypoglycemia (plasma glucose < [amount hidden]/l) from 0-180 minutes post-intervention.

It also tracked 24 secondary outcomes, for example Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention, Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention, Difference between study visits in incremental peak in plasma glucose concentration from 0-180 minutes post-intervention, Difference between study visits in mean plasma glucose concentration from 0-180 minutes post-intervention, Difference between study visits in plasma glucose Area Under the Curve (AUC) from 0-180 minutes post-intervention and Difference between study visits in time (min) to peak plasma glucose concentration from 0-180 minutes post-intervention.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 20 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.