24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

What Was Tested

The trial (phase 3) is built around Lixisenatide.

Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.

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

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 319 actual participants took part.

It was open to people of any sex aged from 18 years up to 49 years.

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

Examples of who could join: Patients with obesity (BMI greater than equal to \[\>=\] 30 kg/m\^2) and aged from 18 years to less than 50 years.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

As a double-blind Lixisenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2009-08 with completion listed for 2011-03.

It ran at 92 sites in United States (21), Canada (10), Mexico (10), Romania (8), Brazil (7) and Australia (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Absolute Change From Baseline in HbA1c at Week 24, Change From Baseline in Body Weight at Week 24, Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change From Baseline in Glucose Excursion at Week 24 and Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lixisenatide in 319 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.