Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

What Was Tested

This registered phase 1 trial tested Liraglutide and Lixisenatide for acid reflux and gerd.

The present study will compare lixisenatide and liraglutide in a population of subjects with T2DM not optimally controlled on OADs and / or insulin, which is the target population for these medications.

It had two arms (groups): Liraglutide (experimental) and Lixisenatide (experimental).

The registry classes the interventions as drug.

Who Took Part

109 actual participants took part.

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

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female aged 18-65 years (both inclusive).

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: contraindications (including known or suspected hypersensitivity) to glp-1 mimetics; use of glp-1 mimetics or dpp-iv inhibitors.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Liraglutide group and the comparison group ran side by side rather than switching.

Only one side, usually the acid reflux and gerd participants, was kept unaware of whether Liraglutide was given.

Those kept unaware of assignments: investigator.

It started in 2015-07-16 with completion listed for 2018-07-23.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline (week -1) in the number of reflux episodes (time frame: 24 hours after 10 weeks of treatment).

It also tracked 1 secondary outcome, for example Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide and Lixisenatide in 109 people with acid reflux and gerd.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page and the Lixisenatide compound page, Acid reflux and GERD research.