Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People

What Was Tested

This registered phase 1, phase 2 trial tested Lixisenatide for low blood pressure and orthostatic hypotension.

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

The registry classes the interventions as drug.

More on the Plan

The study would determine and evaluate for the first time the magnitude of, and the relationship between lixisenatide on glycaemia with those on gastric emptying with scintigraphy.

Postprandial hypotension represents an important clinical disorder that occurs frequently in the elderly and people with type 2 diabetes and for which current management is suboptimal.

While the mechanisms mediating postprandial hypotension are poorly understood, impaired regulation of splanchnic blood flow, gastric distension, the rate of small intestinal delivery and neural and hormonal mechanisms have been identified as possible pathophysiological mechanisms.

However, patients with postprandial hypotension, these responses are inadequate to maintain blood pressure.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Male or female (females using appropriate contraceptive method or willing to undergo pregnancy test). Body Mass Index (BMI) 19 - 30 kg/m2. Type 2 Diabetic Patients:.

How the Study Was Run

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

The low blood pressure and orthostatic hypotension participants were allocated by chance, so the Lixisenatide group and the comparison group should start out alike.

In the crossover set-up each of the low blood pressure and orthostatic hypotension participants took both Lixisenatide and the comparison in turn, acting as their own control.

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 2013-11 with completion listed for 2016-04.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Blood Pressure (time frame: 4.5 hours per study).

It also tracked 3 secondary outcomes, for example Heart rate, Gastric emptying rate and Blood glucose concentration.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Lixisenatide in 30 people with low blood pressure and orthostatic hypotension.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lixisenatide compound page, Low blood pressure and orthostatic hypotension research.