Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 2) is built around Liraglutide and Lixisenatide.

The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY \[PYY3-36\] and oxyntomodulin); and to assess the clinical and laboratory safety profile.

It had two arms (groups): Lixisenatide (experimental) and Liraglutide (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

The duration of the study for each patient is up to 7 weeks including a screening period up to 2 weeks, a treatment period of 4 weeks (Day 1 to Day 28), and an end-of-study visit 7 +/- 2 days after last study drug administration.

Who Took Part

Enrollment: 148 actual participants took part.

It was open to people of any sex aged from 18 years up to 74 years.

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

Examples of who could join: Covered by Health Insurance System where applicable and/or in compliance with the recommendations of the National (German) Law in force relating to biomedical research. Not under any administrative or legal supervision.

The full record lists 4 inclusion and 24 exclusion criteria; among the exclusions: at the time of screening age \<18 years or \>=75 years; body mass index (bmi): \<=20 kilogram per square meter (kg/m\^2) or \>=37 kg/m\^2; history of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2010-08 with completion listed for 2010-11.

It ran at 7 sites in Germany (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28.

It also tracked 9 secondary outcomes, for example Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28, Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28, Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28, Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28, Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28 and Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide and Lixisenatide in 148 people.

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

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