Micro Glucagon During Exercise in Type 1 Diabetes

What Was Tested

In this early phase 1 trial, researchers set out to test Glucagon.

It had three arms (groups): one (experimental), one (experimental) and No treatment (no intervention).

No treatment before the start of exercise.

The registry classes the interventions as drug.

More on the Plan

People with type 1 diabetes (T1D) are recommended to engage in regular exercise for a variety of health and fitness reasons.

Moreover, there is little information on the effects of subcutaneous glucagon on glycogen stores and changes in exercise metabolism.

Secondly, to investigate exercise-metabolism following Dasiglucagon injection using 3 tesla magnetic resonance spectroscopy (MRS) and indirect calorimetry.

Third, to assess participant experience of Dasiglucagon during exercise and the incidence of adverse events.

Who Took Part

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

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

Examples of who could join: T1D for \>1 year. Male aged 18-45 years old. Regular physical activity (defined as meeting 150 min moderate-intensity exercise per week). Using either continuous subcutaneous insulin infusion or multiple daily injections. Written informed consent.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the results as judged by the investigator; current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, sglt2 inhibitors, glp1 agonists; relevant diabetic complications as judged by the investigator.

How the Study Was Run

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

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 2023-04 with completion listed for 2024-04.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Time to hypoglycaemia (time frame: 60 minutes).

It also tracked 8 secondary outcomes, for example Change in glycaemia during exercise, Glucose during exercise, Glucagon during exercise, Time in target, Time in target during exercise and Hypoglycaemia.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.