Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

What Was Tested

The trial (phase 4) is built around Liraglutide.

The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion.

Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration.

The effect of liraglutide on insulin release will be tested using graded glucose infusion test (GGIT) in healthy volunteers.

It had 1 arm (groups): Liraglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 10 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Weight 50-100 kg.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: chronic disease; concomitant drug use; pregnancy or lactation.

How the Study Was Run

It was run as a single-group and open-label study.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-06 with completion listed for 2015-03.

It ran at 1 site in Estonia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in the glucose-sensitivity of the beta cells.

It also tracked 1 secondary outcome, for example Effects on adrenal hormones.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 10 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.