GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

What Was Tested

This registered phase 3 trial tested Exenatide and Lixisenatide.

It had two arms (groups): Lixisenatide (experimental) and Exenatide (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

Patients who complete the 24-week main open-label treatment would undergo a variable open-label extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 24) for the last randomized patient.

Who Took Part

Enrollment: 639 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

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

Because people in this Exenatide 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 Exenatide study did not mask who received what.

It started in 2008-06 with completion listed for 2010-11.

It ran at 18 sites in United States (1), Argentina (1), Austria (1), Brazil (1), Colombia (1) and Denmark (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline, Week 24).

It also tracked 5 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change From Baseline in Body Weight at Week 24 and Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Lixisenatide in 639 people.

With 639 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 Exenatide compound page and the Lixisenatide compound page, all human trials.