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Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial
Plain-language guide to PMID 30903796 (2019): double-blind randomized controlled trial study of Semaglutide in 2463 patients.
Key Facts
- PMID
- 30903796
- Journal
- JAMA
- Year
- 2019
- Study type
- Randomized Controlled Trial
- Authors
- Rosenstock J et al. (10 authors)
- DOI
- 10.1001/jama.2019.2942
- Registered trial
- NCT02607865
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Semaglutide.
Phase 3 trials have not compared oral semaglutide, a glucagon-like peptide 1 receptor agonist, with other classes of glucose-lowering therapy.
Who Took Part
The abstract describes 2463 patients taking part.
PubMed indexes the participants as adults and middle-aged adults, both men and women.
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
How the Study Was Run
In design terms this was a randomized, double-blind and parallel-group 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.
Blinding on both sides kept the patients and researchers unaware of who received Semaglutide.
Groups ran in parallel: each of the patients stayed in one arm throughout.
The timeline in the abstract includes 78 weeks.
Randomized, double-blind, double-dummy, parallel-group, phase 3a trial conducted at 206 sites in 14 countries over 78 weeks from February 2016 to March 2018.
What Was Measured
The subject headings attached to it are Diabetes Mellitus, Type 2, Glucagon-Like Peptide 1, Glucagon-Like Peptides, Glycated Hemoglobin, Hypoglycemic Agents, Metformin and Sitagliptin Phosphate.
What This Means in Plain Language
The paper is a randomized, double-blind and parallel-group study of Semaglutide in 2463 patients over 78 weeks.
With several hundred people or more, it is a fairly large study for this kind of research.
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 (JAMA), a journal based in United States.
More context: the Semaglutide compound page.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.