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

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

This trial is conducted globally (the United States of America excepted).

This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

The registry classes the interventions as drug.

Who Took Part

1041 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Type 2 diabetes. Treatment with oral anti-diabetic drugs for at least 3 months. Body Mass Index (BMI) less than or equal to 45.0 kg/m2.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: treatment with insulin within the last three months; treatment with any drug that could interfere with the glucose level; any serious medical condition.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

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

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2006-05 with completion listed for 2007-05.

It ran at 127 sites in Poland (15), Finland (10), Australia (9), France (9), Italy (8) and Czechia (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: after 26 weeks of treatment).

It also tracked 4 secondary outcomes, for example body weight, Safety and tolerability, beta-cell function and Glycemic control parameters (fasting plasma glucose, -glucose profiles).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 1041 people.

With 1041 participants it is a large trial for this field.

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.