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

What Was Tested

This registered phase 3 trial tested Lixisenatide.

It had two arms (groups): Lixisenatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as device and drug.

More on the Plan

Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patient.

Who Took Part

The registry lists 859 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.

Examples of who could join: Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with a sulfonylurea alone or a sulfonylurea in association with metformin.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Lixisenatide and who got the comparison, which limits bias.

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

As a double-blind Lixisenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2008-07 with completion listed for 2011-01.

It ran at 16 sites in United States (1), Bulgaria (1), Czechia (1), Egypt (1), Germany (1) and India (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline, Week 24).

It also tracked 11 secondary outcomes, for example Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change From Baseline in Body Weight at Week 24, Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24, Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24 and Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin at Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lixisenatide in 859 people.

With 859 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 Lixisenatide compound page, all human trials.