Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial

What Was Tested

This randomized controlled trial paper looks at Semaglutide.

Oral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes.

Who Took Part

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

Participants and site staff were masked to assignment.

Endpoints were change from baseline to week 26 in HbA1c (primary endpoint) and bodyweight (confirmatory secondary endpoint), assessed in all participants with sufficient data.

How the Study Was Run

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

Because people in this Semaglutide 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 Semaglutide, so expectations could not easily colour the readings.

A placebo (an inactive look-alike) gave the Semaglutide group a baseline to be compared against.

This randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries.

This trial is registered on ClinicalTrials.gov, number NCT02827708, and the European Clinical Trials Registry, number EudraCT 2015-005326-19, and is now complete.

What Was Measured

The subject headings attached to it are Diabetes Mellitus, Type 2, Diabetic Nephropathies, Glucagon-Like Peptides, Renal Insufficiency, Glucagon-Like Peptide-1 Receptor Agonists and Semaglutide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2019 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Semaglutide compound page.