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

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 patients.

Who Took Part

Enrollment: 496 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 basal insulin with or without metformin.

The full record lists 1 inclusion and 30 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

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

Because people in this Lixisenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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, care provider, investigator and outcomes assessor.

It started in 2008-07 with completion listed for 2011-02.

It ran at 15 sites in United States (1), Brazil (1), Canada (1), Chile (1), Egypt (1) and France (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 8 secondary outcomes, for example Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24, Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24, 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 Lixisenatide in 496 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.