To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c

What Was Tested

This registered phase 3 trial tested Liraglutide.

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

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes.

The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension.

It had four arms (groups): Lira 1.8 (experimental), Lira 1.2 (experimental), Glimepiride - 1 (active comparator) and Glimepiride - 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 746 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. Body Mass Index (BMI) less than or equal to 45 kg/m\^2.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness; treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound); any serious medical condition.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

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 2006-02 with completion listed for 2008-11.

It ran at 117 sites in United States (102), Mexico (14) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (time frame: week 0, week 52). Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (time frame: week 0, week 104). Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (time frame: week 0, week 156).

It also tracked 14 secondary outcomes, for example Change in Body Weight at Week 52, Change in Body Weight at Week 104, Change in Body Weight at Week 156, Change in Fasting Plasma Glucose at Week 52, Change in Fasting Plasma Glucose at Week 104 and Change in Fasting Plasma Glucose at Week 156.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 746 people.

With 746 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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