Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Europe and Oceania.

The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.

It had three arms (groups): Lira --> placebo (experimental), Placebo --> glim (placebo comparator) and Glim --> lira (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 43 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: Type 2 diabetes mellitus. Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy. Body mass index (BMI) between 27-40 kg/m\^2 (both inclusive). Subjects should be unrestrained eaters.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: recurrent severe hypoglycaemia; impaired liver function; impaired renal function.

How the Study Was Run

The set-up was randomized, crossover and double-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.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2005-11 with completion listed for 2007-09.

It ran at 2 sites in Australia (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10.

It also tracked 7 secondary outcomes, for example The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10, Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10, Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10, Total duration of eating at the buffet meal (satiation), Weight and Waist circumference.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 43 people.

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.