Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Lixisenatide.

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 10 years up to 65 years.

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

Examples of who could join: For paediatric population:body weight \>50kg, BMI \>85th percentile for age and gender and BMI ≤ 50 kg/m². For adults: BMI \> 25 kg/m2 and ≤ 37 kg/m2.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: if female, pregnancy (defined as positive serum pregnancy test), breast-feeding; diabetes other than type 2 diabetes; positive test for insulinoma associated protein (ia2) and glutamic acid decarboxylase (gad) autoantibodies.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Lixisenatide and who got the comparison, which limits bias.

Each person switched between Lixisenatide and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant and investigator.

It started in 2012-05 with completion listed for 2014-03.

It ran at 6 sites in United States (3), Mexico (1), South Africa (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value (time frame: D1 at each period up to 4h30 after study drug injection (8 timepoints)).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Lixisenatide in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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