Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial

What Was Tested

This randomized controlled trial paper looks at Semaglutide.

Given the unique phenotype of type 2 diabetes in Japanese patients, novel therapies such as oral semaglutide require evaluation in this population.

Who Took Part

The abstract describes 2 patients taking part.

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

The primary endpoint was change in HbA1c from baseline to week 26 with the trial product (primary) estimand (which assumes all patients remained on trial product without rescue medication use) in all randomly assigned patients.

How the Study Was Run

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

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

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

PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan.

This trial is registered with ClinicalTrials.gov, NCT03018028.

What Was Measured

Given the unique phenotype of type 2 diabetes in Japanese patients, novel therapies such as oral semaglutide require evaluation in this population.

Topics PubMed links to this paper include Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Glycated Hemoglobin, Hypoglycemic Agents, Glucagon-Like Peptide-1 Receptor Agonists and Semaglutide.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Semaglutide in 2 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 6 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, all human trials.