Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

What Was Tested

The trial (phase 3) is built around Lixisenatide.

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

Placebo (matched to lixisenatide) QD for 24 Weeks.

The registry classes the interventions as drug.

More on the Plan

Approximately 31 weeks including 24 week treatment period.

Who Took Part

350 actual participants took part.

It was open to people of any sex aged from 70 years with no upper age limit.

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

Examples of who could join: Signed written informed consent.

The full record lists 2 inclusion and 21 exclusion criteria; among the exclusions: at screening participants on both basal insulin and sulfonylurea or basal insulin and meglitinides; type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit; type 2 diabetes mellitus diagnosed less than 1 year prior to screening.

How the Study Was Run

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

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.

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 2013-06 with completion listed for 2015-02.

It ran at 83 sites in United States (14), Canada (8), Germany (8), Peru (8), Australia (6) and Spain (6).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 10 secondary outcomes, for example Change in 2-Hour PPG From Baseline to Week 24, Change in Average 7-point SMPG Profiles From Baseline to Week 24, Change in Body Weight From Baseline to Week 24, Change in FPG From Baseline to Week 24, Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period and Change in Plasma Glucose Excursions From Baseline to Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lixisenatide in 350 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.