Comparison of Two Liraglutide Formulations in Healthy Volunteers

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 two formulations of liraglutide.

It had two arms (groups): Phase 2 formulation (experimental) and Phase 3 formulation (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 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. Body Mass Index (BMI) of 18-27 kg/m\^2 incl.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: impaired renal function; uncontrolled treated/untreated hypertension; active hepatitis b and/or active hepatitis c.

How the Study Was Run

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

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

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

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2004-05-28 with completion listed for 2004-06-30.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the Curve (AUC) (0-t). Cmax, maximum concentration.

It also tracked 5 secondary outcomes, for example AUC (0-infinity), tmax, time to maximum concentration, 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.