To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted in Europe, Oceania, Africa, Asia and South America.

This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride.

Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

It had five arms (groups): Lira 0.6 + Met (experimental), Lira 1.2 + Met (experimental), Lira 1.8 + Met (experimental), Met Mono (active comparator) and Met + Glim (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1091 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: Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months. Body Mass Index (BMI) less than or equal 40 kg/m2.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: subjects treated with insulin within the last three months; subjects with any serious medical condition; females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods.

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 190 sites in Germany (42), Australia (22), Spain (15), Italy (14), United Kingdom (14) and Denmark (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated A1c (HbA1c) at Week 26 (time frame: week 0, week 26). Change in Glycosylated A1c (HbA1c) at Week 104 (time frame: week 0, week 104).

It also tracked 12 secondary outcomes, for example Change in Body Weight at Week 26, Change in Body Weight at Week 104, Change in Fasting Plasma Glucose (FPG) at Week 26, Change in Fasting Plasma Glucose (FPG) at Week 104, Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26 and Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 1091 people.

With 1091 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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