The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted in Europe and North America.

The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks.

It had five arms (groups): one (experimental), one (experimental), Sita -> Sita (active comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 665 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 metformin alone for at least three months. Body Mass Index (BMI) less than or equal to 45.0.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: previous treatment with insulin, glucagon like peptide-1 (glp-1) receptor agonists or dipeptidyl peptidase-4 (dpp-4) inhibitors; treatment with anti-diabetic drugs other than metformin within the last three months; any serious medical condition.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2008-06 with completion listed for 2009-06.

It ran at 166 sites in United States (60), United Kingdom (20), Germany (12), Canada (11), Netherlands (10) and Italy (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (time frame: Week 0, Week 26). Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (time frame: Week 0, Week 52). Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 (time frame: Week 0, Week 78).

It also tracked 71 secondary outcomes, for example Mean Change From Baseline in Body Weight at Week 26, Mean Change From Baseline in Body Weight at Week 52, Mean Change in Body Weight From Week 52 to Week 78, Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 and Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 665 people.

With 665 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.