Lixisenatide-The Effects on Glucose and Lipid Metabolism in Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Lixisenatide.

Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which consist of very low-density lipoproteins, (VLDL) synthesised by the liver which contain the higher molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are synthesised in the intestine in response to an intake of dietary fat and contain the lower molecular weight form of apoB, apoB-48.

It had two arms (groups): Placebo (placebo comparator) and Lixisenatide (experimental).

The registry classes the interventions as other.

More on the Plan

Chylomicron and VLDL production and clearance rates will be measured in a repeated meal study (Visits 4 and 8) by labelling apoB-100 and apoB-48 with 1-13C leucine (infusion for 8 hours) and by labelling triglycerides with \[1,1,2,3,3-2H5 \]glycerol (as a bolus injection) and 13C triolein.

Blood samples will be taken for 4 hours prior to during the 8 hr isotopic infusion to measure the enrichment of apoB-100 and apoB-48 with 1-13C leucine by gas chromatography mass spectrometry.

At Visits 3 and 7, glucose flux in response to a mixed fluid meal containing U-13C glucose will be investigated.

Endogenous glucose production will also be measured by infusing \[6,6-2H2\] glucose for 6hours.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to men only aged from 40 years up to 65 years.

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

Examples of who could join: Subjects with type 2 diabetes inadequately controlled by metformin. 40-65 years (inclusive). BMI 27-40 kg/m2 (inclusive). Able and willing to self-administer placebo/lixisenatide injection. Able and willing to perform self-blood glucose monitoring.

The full record lists 10 inclusion and 23 exclusion criteria; among the exclusions: subjects treated with insulin, any oral hypoglycaemic agents (oha) (other than metformin), any insulin secretagogue or thiazolidinediones (tzds); ischemic cerebrovascular disease, including:; history of ischemic stroke.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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.

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

Neither the participants nor the staff measuring them knew who was on Lixisenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-01 with completion listed for 2016-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Postprandial glucose kinetics (time frame: Two years).

It also tracked 1 secondary outcome, for example Postprandial and intestinal triglyceride-rich lipoproteins (TRL) kinetics.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Lixisenatide in 8 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.