Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

What Was Tested

The trial (phase 3) is built around Lixisenatide.

It had two arms (groups): Lixisenatide Main Meal (experimental) and Lixisenatide Breakfast (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

Who Took Part

Enrollment: 451 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: Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit.

The full record lists 2 inclusion and 14 exclusion criteria; among the exclusions: treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin; participants who usually did not eat breakfast; type 1 diabetes mellitus.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Everyone knew when Lixisenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-02 with completion listed for 2013-05.

It ran at 82 sites in United States (17), Canada (11), Russia (9), Poland (8), Spain (8) and Germany (7).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 9 secondary outcomes, for example Change in Average 7-point SMPG Profiles From Baseline to Week 24, Change in FPG From Baseline to Week 24, Change in Body Weight From Baseline to Week 24 and Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lixisenatide in 451 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.