The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus

What Was Tested

In this not phased trial, researchers set out to test Glucagon.

This project is part of several studies exploring situations, where glucagon potential has lesser glucose elevating effect.

The investigators aims are: 1.

It had three arms (groups): Exercise and glucagon before exercise (experimental), Exercise and glucagon after exercise (active comparator) and Resting and glucagon after resting (active comparator).

The registry classes the interventions as drug.

More on the Plan

Design: A randomized placebo-controlled single-blinded study will be conducted.

The subjects do not know if they get glucagon or placebo but the investigator know if the subject get glucagon or placebo.

Study participants have to complete three study days and serve as their own controls.

After participants have given an informed consent, they will go through three steps: 1.

Who Took Part

The registry lists 14 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: Type 1 Diabetes ≥ 2 year. BMI 20-30 kg/m2. Insulin pump ≥ 1 year. Hypoglycemia awareness (reported by Gold et al.). Use of carbohydrate counting and the insulin pump bolus calculator for all meals.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: liver disease with alat \> 2.5 times the upper limit of the reference interval; known or suspected alcohol or drug abuse; other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation.

How the Study Was Run

Design: randomized, crossover and single-blind.

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.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2016-09 with completion listed for 2017-07-11.

It ran at 1 site in Denmark.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: The primary endpoint is peak plasma glucose achieved within 2 hours after the [amount hidden] subcutaneous glucagon injection. In the primary analysis, the investigators will compare the peak plasma glucose after exercise and after resting.

It also tracked 24 secondary outcomes, for example The time-to-peak value after glucagon injection, Duration of the glucagon effect; equal to the time point from glucagon injection to when plasma glucose is below baseline, The glycaemic effect, calculated as the total area under the curve (tAUC) after each glucagon injection, Changes in plasma ketone bodies after each glucagon injection, Changes in plasma lactic acid after each glucagon injection and Changes in plasma glucagon after each glucagon injection.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 14 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.