Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

What Was Tested

This registered phase 2 trial tested Lixisenatide.

Primary Objective: To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides.

Secondary Objectives: The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation.

The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity.

It had two arms (groups): lixisenatide (experimental) and metformin (no intervention).

The registry classes the interventions as drug.

More on the Plan

Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (Final/End-of-treatment Visit).

Who Took Part

Enrollment: 2 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Abdominal obesity (waist circumference \>102 cm in men and \>88 cm in women). According to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001).

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Because people in this Lixisenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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 2015-04 with completion listed for 2015-08.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min) (time frame: After 10 weeks of treatment).

It also tracked 11 secondary outcomes, for example Change from baseline in plasma triglyceride, Change from baseline in plasma cholesterol, Change from baseline in APO B48, Change from baseline in free fatty acid levels, Change from baseline in lipoprotein distribution and Change from baseline in LDL oxidation.

What This Means in Plain Language

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

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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