Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Liraglutide.

This is an open-label comparative study in three parallel groups.

It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research.

Distribution in groups * 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1) * 30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2) * 30 healthy subjects (non-diabetics) (group 3) This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).

It had three arms (groups): type 2 diabetics treated with GLP1 analogue (experimental), Type 2 diabetics not treated with incretins (active comparator) and Healthy subjects (other).

The registry classes the interventions as drug and other.

Who Took Part

48 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Persons who have provided written informed consent. Aged \> 18 years. Overweight (BMI \> 27). Persons who have provided written informed consent. Aged \> 18 years.

The full record lists 14 inclusion and 40 exclusion criteria; among the exclusions: type 1 diabetes; decompensated congestive heart failure; acute or chronic infection, progressive cancer, liver cirrhosis.

How the Study Was Run

Design: parallel-group.

Groups ran in parallel: each of the participants stayed in one arm throughout.

It started in 2014-02-04 with completion listed for 2016-08-31.

It ran at 1 site in France.

What Was Measured

Primary outcome: Modifications in wanting (time frame: Up to 3 months).

It also tracked 5 secondary outcomes, for example Modifications in gustatory performance, Modifications in liking, Modifications in salivation following the presentation of foods, Modifications in optimal preferences for sweet and fatty tastes and Anthropometric modifications.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 48 people.

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

More context: the Liraglutide compound page, all human trials.