Comparison of Two Liraglutide Formulations 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 test for bioequivalence of the phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).

It had two arms (groups): Formulation 3 (experimental) and Formulation 4 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments. BMI (Body Mass Index) of 18.0-27.0 kg/m\^2, both inclusive.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: impaired renal function; active hepatitis b and/or active hepatitis c; positive human immunodeficiency virus (hiv) antibodies.

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2006-04 with completion listed for 2006-06.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the curve (0-t). Cmax, maximum concentration.

It also tracked 5 secondary outcomes, for example Area under the curve, tmax, time to reach Cmax, t½, terminal half-life, Terminal elimination rate constant and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 22 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.