Effect of Liraglutide or Glimepiride Added to Metformin 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 Asia.

The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes.

It had four arms (groups): Lira 0.6 + Met (experimental), Lira 1.2 + Met (experimental), Lira 1.8 + Met (experimental) and Glim + Met (experimental).

Liraglutide + metformin + glimepiride placebo.

The registry classes the interventions as drug.

Who Took Part

The registry lists 929 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. Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months. BMI less than 45.0 kg/m\^2.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: treatment with insulin within the last 3 months prior to the trial; impaired liver or/and renal function; known retinopathy or maculopathy.

How the Study Was Run

Design: 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 2008-01 with completion listed for 2009-02.

It ran at 50 sites in India (24), China (16) and South Korea (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycosylated Haemoglobin A1c (HbA1c) (time frame: week 0, week 16).

It also tracked 7 secondary outcomes, for example Change in Body Weight, Change in Self-measured Fasting Plasma Glucose, 7-point Self-measured Plasma Glucose Profiles, Change in Beta-cell Function, Change in Fasting Lipid Profile and Change in Fasting Lipid Profile, APO-B.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 929 people.

With 929 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.