Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: Rationale, design and patient baseline characteristics for the PIONEER 6 trial

What Was Tested

Researchers studied Semaglutide in this clinical study publication.

To assess the cardiovascular (CV) safety of oral semaglutide, the first tablet formulation of a glucagon-like peptide-1 receptor agonist.

Who Took Part

PubMed indexes the participants as middle-aged adults, older adults and people over 80, both men and women.

PIONEER 6 is a multinational, randomized, placebo-controlled, double-blind trial in patients with type 2 diabetes at high risk of CV events (defined as being aged ≥50 years and having established CV disease [CVD] or moderate [stage 3] chronic kidney disease [CKD], or being aged ≥60 years with ≥1 other CV risk factor).

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Some participants received a placebo instead of Semaglutide, giving a reference point.

More than one site took part, so the participants came from several places.

PIONEER 6 is event-driven, with follow-up continuing until accrual of at least 122 primary outcome events.

There is no pre-defined minimal duration.

What Was Measured

Topics PubMed links to this paper include Cardiovascular Diseases, Cardiovascular System, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Glucagon-Like Peptides, Hypoglycemic Agents and Metformin.

The authors tagged it with the keywords GLP-1 receptor agonist, cardiovascular outcomes trial, oral semaglutide and type 2 diabetes.

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 3 sentences; this page does not restate them, so read the paper for the findings and their limits.

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

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