Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 142 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Participants with T2DM diagnosed at least 1 year before the screening visit. Body mass index (BMI) between 20 and 40 kg/m\^2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: pregnant women or breastfeeding women; allergic reaction to any glucagon-like peptide-1 (glp-1) agonist in the past (eg, exenatide) or to metacresol; history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.

How the Study Was Run

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

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.

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

It started in 2012-05 with completion listed for 2013-07.

It ran at 8 sites in Germany (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours.

It also tracked 16 secondary outcomes, for example Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours, Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56, Change From Baseline to Day 56 in PPG Excursion, Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG), Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG) and Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine and Liraglutide in 142 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 Liraglutide compound page, all human trials.