Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial

What Was Tested

This randomized controlled trial paper looks at Semaglutide and Dulaglutide.

New glucose-lowering medications need to be investigated in east Asian populations, as the clinical characteristics of type 2 diabetes differ between western and east Asian patients.

Who Took Part

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults, both men and women.

The primary endpoint was the number of treatment-emergent adverse events over 57 weeks.

How the Study Was Run

In design terms this was a randomized and open-label study.

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

Being open-label, the Semaglutide study did not mask who received what.

A time span of 57 weeks appears in the methods.

PIONEER 10 was an open-label, randomised, active-controlled, phase 3a trial done at 36 sites (clinics and university hospitals) in Japan.

Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA1c and bodyweight at 52 weeks.

This trial is registered with ClinicalTrials.gov, NCT03015220.

What Was Measured

Topics PubMed links to this paper include Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Glycated Hemoglobin, Hypoglycemic Agents, Immunoglobulin Fc Fragments, Recombinant Fusion Proteins and Semaglutide.

What This Means in Plain Language

The paper is a randomized and open-label study of Semaglutide and Dulaglutide over 57 weeks.

The abstract goes on to report its results in about 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2020 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Semaglutide compound page and the Dulaglutide compound page.