LivingGLP1
Study S000133

Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT02863419
Acronym
PIONEER 4
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
711
Start
2016-08-10
Primary completion
2017-08-19
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes; Diabetes Mellitus, Type 2
Interventions
DRUG:semaglutide; DRUG:liraglutide; DRUG:placebo
Results posted
TRUE
Secondary identifiers
EUDRACT_NUMBER:2015-005210-30; OTHER:U1111-1176-6029; NIH:2015

Registered primary outcomes

  • Change in HbA1c (Week 26) [Week 0, week 26]

Linked records (11)

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.
RecordTitleYearDesignIdentifiersLink basis
R0048770Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses
Buse J.B, Carolina Digital Repository (University of North Carolina at Chapel Hill)
2024Other trialDOIcites ClinicalTrials.gov:NCT02863419
R0008944Early use of oral semaglutide in the UK: A cost-effectiveness analysis versus continuing metformin and SGLT-2 inhibitor therapy.
Ren H, BMJ open
2023Other trialPMID 37775297DOIcites ClinicalTrials.gov:NCT02863419; registry reference DERIVED:37775297
R0021795Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme.
Aroda VR, Diabetes, obesity & metabolism
2022Other trialPMID 35373893DOIregistry reference RESULT:35373893
R0012356Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses.
Pratley RE, Diabetes therapy : research, treatment and education of diabetes and related disorders
2021Other trialPMID 33660198DOIcites ClinicalTrials.gov:NCT02863419; registry reference DERIVED:33660198
R0020297Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials.
Araki E, Diabetes, obesity & metabolism
2021Randomized trialPMID 34472698DOIregistry reference RESULT:34472698
R0007971Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme.
Thethi TK, Diabetes, obesity & metabolism
2020Randomized trialPMID 32267058DOIcites ClinicalTrials.gov:NCT02863419; registry reference DERIVED:32267058
R0018529Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Husain M, Cardiovascular diabetology
2020Randomized trialPMID 32998732DOIcites ClinicalTrials.gov:NCT02863419
R0018857Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Husain M, Diabetes, obesity & metabolism
2020OtherPMID 31903692DOIcites ClinicalTrials.gov:NCT02863419; registry reference DERIVED:31903692
R0050869927-P: Effect of Oral Semaglutide with or without Background SGLT2i in Patients with T2D: Subgroup Analysis of PIONEER 4
Richard E. Pratley, Diabetes
2020Randomized trialDOIcites ClinicalTrials.gov:NCT02863419
R0015836Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial.
Pratley R, Lancet (London, England)
2019Randomized trialPMID 31186120DOIcites ClinicalTrials.gov:NCT02863419; cites EudraCT:2015-005210-30; registry reference RESULT:31186120
R004867655-OR: Oral Semaglutide vs. Liraglutide and Placebo in T2D: PIONEER 4
Richard E. Pratley, Diabetes
2019Randomized trialDOIcites ClinicalTrials.gov:NCT02863419