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

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted in the United States of America (USA) and Canada.

This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.

The registry classes the interventions as drug.

Who Took Part

576 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. Treated with oral anti-diabetic (OAD) drugs for at least 3 months. Treated with one or more OAD and in moderate to poor glycemic control. Body Mass Index (BMI) less than or equal to 45.0 kg/m2.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the investigator; any serious medical condition; treatment with any drug that could interfere with glucose level.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

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 2007-08.

It ran at 89 sites in United States (71) and Canada (18).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: after 26 weeks of treatment).

It also tracked 3 secondary outcomes, for example body weight, Safety and tolerability and Glycaemic control.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 576 people.

With 576 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.