Comparison of Liraglutide Injected at Three Different Injection Sites in Healthy Volunteers

What Was Tested

This registered phase 1 trial tested Liraglutide.

It had three arms (groups): Abdomen (experimental), Thigh (experimental) and Upper arm (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 21 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): 18.5-27.5 kg/m\^2, both inclusive.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; the receipt of any investigational drug within 3 months prior to this trial; impaired renal function.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

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

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

It started in 2007-02 with completion listed for 2007-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the Curve (AUC) of liraglutide for each injection site.

It also tracked 7 secondary outcomes, for example AUC, Cmax, maximum concentration, tmax, time to maximum concentration, t½, terminal half-life, Terminal elimination rate constant and Relative Bioavailability.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 21 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.