GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

What Was Tested

The trial (phase 3) is built around Lixisenatide.

It had four arms (groups): Placebo (Two-Step Titration) (placebo comparator), Placebo (One-Step Titration) (placebo comparator), Lixisenatide (Two-Step Titration) (experimental) and Lixisenatide (One-Step Titration) (experimental).

The registry classes the interventions as device and drug.

More on the Plan

This is a double-blind, randomized, placebo-controlled, 4-arm, unbalanced design, parallel group study with a two-step titration regimen or a one-step titration regimen.

The study is double-blind with regard to active and placebo treatments; however neither the study drug volume nor the titration regimens (that is, two-step or one-step) are blinded.

Who Took Part

The registry lists 361 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 2 months at the time of the screening visit, not treated with any antidiabetic agent.

The full record lists 1 inclusion and 25 exclusion criteria; among the exclusions: at the time of screening age \< legal age of majority; type 1 diabetes mellitus; type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Lixisenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Lixisenatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-05 with completion listed for 2009-12.

It ran at 12 sites in United States (1), Belgium (1), India (1), Israel (1), Japan (1) and Mexico (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 12 (time frame: Baseline, Week 12).

It also tracked 6 secondary outcomes, for example Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12, Change From Baseline in Body Weight at Week 12, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lixisenatide in 361 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.