24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and 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

Maximum duration is of 39 weeks +/- 7 days.

Who Took Part

446 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.

The full record lists 0 inclusion and 25 exclusion criteria; among the exclusions: at the time of screening age \< legal age of majority; type 1 diabetes mellitus; history of hypoglycemia unawareness.

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 Insulin Glargine and who got the comparison, which limits bias.

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 Insulin Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2009-10 with completion listed for 2011-08.

It ran at 140 sites in United States (23), Canada (11), India (10), Romania (8), Argentina (7) and Hungary (7).

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 10 secondary outcomes, for example Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24, Change From Baseline in Glucose Excursion at Week 24, Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24, Change From Baseline in Body Weight at Week 24, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 and Percentage of Patients Requiring Rescue Therapy During the Double-blind Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Lixisenatide in 446 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Lixisenatide compound page, all human trials.