Study S001571

Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04707469
Acronym: PIONEER PLUS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 1606
Start: 2021-01-15
Primary completion: 2023-03-07
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Oral semaglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1247-0210; REGISTRY:2020-000299-39

Registered primary outcomes

Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52) [Baseline (week 0), week 52]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0045424	2836-LB: HbA1c and Weight Outcomes among Adults with Type 2 Diabetes on 25 mg Oral Semaglutide Previously Treated with Metformin Only: A Post hoc Analysis from PIONEER PLUS LIN XIE, Diabetes	2026	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04707469
R0045467	2843-LB: HbA1c and Weight Outcomes for Individuals with T2D Persistent on 25mg Oral Semaglutide: A PIONEER PLUS Post-Hoc Analysis Yeshaben Patel, Diabetes	2026	Other trial	DOI	cites ClinicalTrials.gov:NCT04707469
R0021620	Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. Aroda VR, Lancet (London, England)	2023	Randomized trial	PMID 37385279 DOI	cites ClinicalTrials.gov:NCT04707469; cites EudraCT:2020-000299-39; registry reference RESULT:37385279