Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake

What Was Tested

In this phase 2 trial, researchers set out to test Dulaglutide.

The aim of this study is to elucidate whether GLP-1 analogues influence not only appetite but also thirst perception.

It had two arms (groups): Dulaglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 17 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

The full record lists 0 inclusion and 9 exclusion criteria; among the exclusions: known or probable central or nephrogenic diabetes insipidus, based on patient's history; polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia; primary polydipsia, defined as more than 4 liters fluid intake per day.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

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

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-10-17 with completion listed for 2017-05.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Fluid intake (time frame: 8 hours).

It also tracked 16 secondary outcomes, for example Thirst, Urine volume, Urinary sodium, Electrolytes, Urine electrolytes and copeptin.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 17 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 Dulaglutide compound page, all human trials.