The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Europe.

The aim of this trial is to investigate if liraglutide adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment with liraglutide or placebo.

It had three arms (groups): Low (experimental), Medium (experimental) and High (experimental).

The registry classes the interventions as drug.

Who Took Part

45 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 mellitus (as diagnosed clinically) for at least 12 months prior to randomisation. Body mass index (BMI) between 20.0 and 28.0 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: use of liraglutide or exenatide within 3 months of randomisation.

How the Study Was Run

Design: randomized, crossover and double-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2012-02 with completion listed for 2012-08.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target [amount hidden]/L) ).

It also tracked 3 secondary outcomes, for example Geometric mean glucagon concentration at plasma glucose levels other than nadir, Geometric mean concentrations of adrenaline and noradrenaline at nadir and Time from termination of insulin infusion at nadir to reach plasma glucose 4.0.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 45 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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