GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA)

What Was Tested

In this phase 3 trial, researchers set out to test Lixisenatide.

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

The registry classes the interventions as device and drug.

Who Took Part

311 actual participants took part.

It was open to people of any sex aged from 19 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 at the time of the screening visit, insufficiently controlled with basal insulin with or without sulfonylurea.

The full record lists 1 inclusion and 29 exclusion criteria; among the exclusions: at the time of screening age \<legal age of majority; type 1 diabetes mellitus; treatment with basal insulin for less than 3 months prior to screening or insulin regimen changed during the last 3 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

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 Lixisenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2009-03 with completion listed for 2010-06.

It ran at 4 sites in Japan (1), Philippines (1), South Korea (1) and Taiwan (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline, Week 24).

It also tracked 8 secondary outcomes, for example Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24, Change From Baseline in Body Weight at Week 24, Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 and Percentage of Patients Requiring Rescue Therapy During 24-Week Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lixisenatide in 311 people.

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.