Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in Europe.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male or female, age 18-60 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) greater than or equal to 27.0 and less than 35.0 kg/m\^2. Bodyweight up to 130.0 kg (inclusive).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods.

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.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2014-08 with completion listed for 2014-09.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Number of treatment emergent adverse events (TEAEs).

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.