Safety and Tolerability of Insulin Degludec/Liraglutide (A3) in Healthy Subjects

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Europe.

The aim of this trial is to compare the bioavailability of insulin degludec and liraglutide, when administered either combined or as separate administrations.

It had three arms (groups): IDegLira (experimental), IDeg (active comparator) and Lira (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). Body Mass Index (BMI) between 20.0 and 27.0 kg/m\^2 (both inclusive). Body weight between 75 kg and 90 kg (both inclusive).

The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; previous participation in this trial. participation is defined as randomised; family or personal history of men2 (multiple endocrine neoplasia syndrome type 2) or familial medullary thyroid carcinoma (fmtc).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

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

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2011-03 with completion listed for 2011-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The area under insulin degludec concentration-time curve (time frame: from 0-infinity hours after trial product administration). The area under liraglutide concentration-time curve (time frame: from 0-infinity hours after trial product administration).

It also tracked 5 secondary outcomes, for example The area under insulin degludec concentration-time curve, The area under liraglutide concentration-time curve, Maximum concentration of insulin degludec, Maximum concentration of liraglutide and Number of hypoglycaemic episodes.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide 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 Liraglutide compound page, all human trials.