The Impact of Lixisenatide on Postprandial Glucose Tolerance in Pancreatectomised Subjects

What Was Tested

In this not phased trial, researchers set out to test Lixisenatide for pancreatitis (after the acute phase).

Postprandial glucose (PPG) excursions are not only determined by insulin-mediated glucose disposal and endogenous glucose production (regulated by insulin and glucagon); also the rate of gastric emptying constitutes an important determinant of PPG levels 1.

The short-acting glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide is used in the treatment of type 2 diabetes.

It had four arms (groups): Pancreatectomised + Lixisenatide (active comparator), Pancreatectomized + lixisenatide-placebo (placebo comparator), Healthy + Lixisenatide (active comparator) and Healthy + lixisenatide-placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Caucasians above 18 years of age who have undergone total pancreatectomy. Informed consent Healthy subjects. Normal fasting plasma glucose (FPG) and normal HbA1C (according to the World Health Organization (WHO) criteria). Age above 18 years.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: inflammatory bowel disease; operation within the last 3 months; ongoing chemotherapy or chemotherapy within the last 3 months.

How the Study Was Run

The set-up was randomized, crossover and double-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.

In the crossover set-up each of the pancreatitis (after the acute phase) participants took both Lixisenatide and the comparison in turn, acting as their own control.

Neither the pancreatitis (after the acute phase) 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 and investigator.

It started in 2015-08 with completion listed for 2016-07.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: PPG excursions measured as incremental area under curve (iAUC) (time frame: -120,-45,-30,-15,0,5,10,15,20,25,30,40,50,60,70,80,90,105,120,135,150,180 minutes).

It also tracked 6 secondary outcomes, for example differences in gastric emptying, measurement of s-paracetamol, food intake and appetite, resting energy expenditure (REE), p-glucose mmol/L, p-C-peptide pmol/l and glucagon, gastrin, cholecystokinin, GIP, GLP-1, oxyntomodulin.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Lixisenatide in 24 people with pancreatitis (after the acute phase).

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, Pancreatitis (after the acute phase) research.