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Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial
Plain-language guide to PMID 31186120 (2019): double-blind randomized controlled trial study of Semaglutide and Liraglutide.
Key Facts
- PMID
- 31186120
- Journal
- Lancet (London, England)
- Year
- 2019
- Study type
- Randomized Controlled Trial
- Authors
- Pratley R et al. (9 authors)
- DOI
- 10.1016/S0140-6736(19)31271-1
- Registered trial
- NCT02863419
What This Study Did, in Plain Language
What Was Tested
The paper reports a study of Semaglutide and Liraglutide, published as a randomized controlled trial.
Oral semaglutide, a novel GLP-1 agonist, was compared with subcutaneous liraglutide and placebo in patients with type 2 diabetes.
Who Took Part
By PubMed's age tags, the people studied were middle-aged adults and older adults, both men and women.
In this randomised, double-blind, double-dummy, phase 3a trial, the researchers recruited patients with type 2 diabetes from 100 sites in 12 countries.
Two estimands were defined: treatment policy (regardless of study drug discontinuation or rescue medication) and trial product (assumed all participants were on study drug without rescue medication) in all participants who were randomly assigned.
How the Study Was Run
In design terms this was a randomized, double-blind and placebo-controlled study.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.
The comparison arm used a placebo, so changes seen with Semaglutide could be set against what happens without it.
The treatment policy estimand was the primary estimand.
This trial is registered on Clinicaltrials.gov, number NCT02863419, and the European Clinical Trials registry, number EudraCT 2015-005210-30.
What Was Measured
Topics PubMed links to this paper include Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Liraglutide, Metformin and Semaglutide.
What This Means in Plain Language
The paper is a randomized, double-blind and placebo-controlled study of Semaglutide and Liraglutide.
Results are reported in around 11 sentences of the abstract; we leave them to the paper itself rather than summarise them.
The publication is from 2019 (Lancet (London, England)), a journal based in England.
More context: the Semaglutide compound page and the Liraglutide compound page.
Our Notes on the Compounds
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
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.