Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Glucagon.

It had two arms (groups): Usual care (no intervention) and Dasiglucagon (experimental).

During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension.

The registry classes the interventions as drug.

More on the Plan

A randomized, open-label, two-arm, two-week crossover study will be conducted to assess the study objectives.

Upon study enrollment, participants will complete two consecutive 2-week periods - a 'usual care' period and 'dasiglucagon' period.

During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age ≥ 18 years. T1D ≥ 2 years. Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) ≥ 6 months. Use of carbohydrate counting and bolus calculator (self-reported).

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: known or suspected allergies to glucagon or related products; history of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients; patients with pheochromocytoma or insulinoma.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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.

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Glucagon study: the participants and staff both knew the treatment.

It started in 2021-04-27 with completion listed for 2021-12-30.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Difference in percentage of time in range between the two study periods (time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period).

It also tracked 13 secondary outcomes, for example Difference in percentage of time in hypoglycemia between the two study periods, Difference in percentage of time in hyperglycemia between the two study periods, Difference in coefficient of variation (%) between the two study periods, Difference between successful cases (%) of hypoglycemia treatment between the two study periods, Difference in time from hypoglycemia treatment to euglycemia between the two study periods and Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 24 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.