Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted in Europe.

The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes.

Liraglutide or placebo is administered by injection once daily in the evening.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 177 actual participants took part.

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

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

Examples of who could join: Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy. Body Mass Index (BMI): max 40 kg/m\^2.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: subjects treated with thiazolidinediones or insulin; subjects with any serious medical conditions.

How the Study Was Run

The set-up was randomized, parallel-group 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.

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2005-01 with completion listed for 2005-10.

It ran at 39 sites in France (12), Slovakia (12), Denmark (8) and Netherlands (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: after 14 weeks treatment).

It also tracked 3 secondary outcomes, for example Body weight after 14 weeks, Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks and Safety and tolerability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 177 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.