Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data

What Was Tested

This randomized controlled trial paper looks at Relamorelin.

To assess the safety and tolerability of relamorelin across phase 2 trials.

Who Took Part

The age groups tagged for this paper are teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

Safety assessments in patients aged 18-75 years (weight, adverse events [AEs] and laboratory tests) from two randomised, double-blind phase 2 trials (NCT01571297, NCT02357420; results published previously) were reviewed descriptively.

Analysis of covariance assessed treatment effect on glycated haemoglobin (HbA1c) and blood glucose post hoc.

How the Study Was Run

The researchers set it up as a randomized, double-blind, single-blind and placebo-controlled study.

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

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

In this single-blind Relamorelin study one party knew the assignments and the other did not.

The comparison arm used a placebo, so changes seen with Relamorelin could be set against what happens without it.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Diabetes Mellitus, Type 2, Diabetic Neuropathies, Gastric Emptying, Gastroparesis and Oligopeptides.

What This Means in Plain Language

The paper is a randomized, double-blind and single-blind study of Relamorelin.

Its findings take up roughly 8 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2020 (Alimentary pharmacology & therapeutics), a journal based in England.

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