Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human) and Liraglutide for lung health, asthma & copd.

This trial is conducted in Europe.

The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.

It had four arms (groups): one (experimental), NNC 90-1170 (experimental), Insulin (active comparator) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 32 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: No clinically important abnormal physical findings. No clinically relevant abnormalities in the results of laboratory screening evaluation.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis; subjects with first and/or second degree relative(s) with diabetes mellitus; current addiction to alcohol or substances of abuse.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

In the crossover set-up each of the lung health, asthma & copd participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2001-10 with completion listed for 2001-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ratio of the areas under the plasma NN 90-1170 curves.

It also tracked 6 secondary outcomes, for example The maximum concentration (Cmax), The time to maximum concentration (tmax), Mean residence time (MRT), Area under the curve, Terminal rate constant and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Liraglutide in 32 people with lung health, asthma & copd.

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 Insulin (regular human) compound page and the Liraglutide compound page, Lung health, asthma & COPD research.