LivingGLP1
Study S000251

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

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

Registration

Registration
NCT02863328
Acronym
PIONEER 2
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
822
Start
2016-08-10
Primary completion
2017-08-01
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes; Diabetes Mellitus, Type 2
Interventions
DRUG:semaglutide; DRUG:empagliflozin
Results posted
TRUE
Secondary identifiers
EUDRACT_NUMBER:2015-005209-36; OTHER:U1111-1176-6006; NIH:2015

Registered primary outcomes

  • Change in HbA1c [Week 0, week 26]

Linked records (16)

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
R0020952Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study.
Pulleyblank R, PharmacoEconomics - open
2023Nonrandomized studyPMID 37178435DOIcites ClinicalTrials.gov:NCT02863328; registry reference DERIVED:37178435
R0008394Abstract 25: Glycemic variability of oral semaglutide versus empagliflozin: A post hoc analysis of PIONEER 2
, Indian Journal of Endocrinology and Metabolism
2022Randomized trialcites ClinicalTrials.gov:NCT02863328
R0019127Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials.
Mosenzon O, Cardiovascular diabetology
2022Randomized trialPMID 36056351DOIcites ClinicalTrials.gov:NCT02863328; registry reference DERIVED:36056351
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
R0022514Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting.
Eliasson B, PharmacoEconomics - open
2022Nonrandomized studyPMID 35064550DOIcites ClinicalTrials.gov:NCT02863328; registry reference RESULT:35064550
R0024725Abstract 34: Time spent in glycemic control after initiating treatment with oral semaglutide versus empagliflozin: An exploratory analysis of the PIONEER 2 trial
, Indian Journal of Endocrinology and Metabolism
2022Randomized trialcites ClinicalTrials.gov:NCT02863328
R0046993Abstract 25: Glycemic variability of oral semaglutide versus empagliflozin: A post hoc analysis of PIONEER 2
D Shabeer, Indian Journal of Endocrinology and Metabolism
2022Randomized trialDOIcites ClinicalTrials.gov:NCT02863328
R0051271Abstract 34: Time spent in glycemic control after initiating treatment with oral semaglutide versus empagliflozin: An exploratory analysis of the PIONEER 2 trial
Prashanth S Prakash, Indian Journal of Endocrinology and Metabolism
2022Randomized trialDOIcites ClinicalTrials.gov:NCT02863328
R0050257670-P: Time Spent in Glycemic Control after Initiating Treatment with Oral Semaglutide vs. Empagliflozin: An Exploratory Analysis of the PIONEER 2 Trial
Julio Rosenstock, Diabetes
2021Randomized trialDOIcites ClinicalTrials.gov:NCT02863328
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:NCT02863328; registry reference DERIVED:32267058
R0018492Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis.
Lingvay I, The Journal of clinical endocrinology and metabolism
2020Systematic reviewPMID 32827435DOIcites ClinicalTrials.gov:NCT02863328; registry reference DERIVED:32827435
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:NCT02863328
R0018857Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Husain M, Diabetes, obesity & metabolism
2020OtherPMID 31903692DOIcites ClinicalTrials.gov:NCT02863328; registry reference DERIVED:31903692
R00521011163-P: Cost Effectiveness of Oral Semaglutide 14mg vs. Empagliflozin 25mg in Canada
Aiden R. Liu, Diabetes
2020Randomized trialDOIcites ClinicalTrials.gov:NCT02863328
R0018256Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial.
Rodbard HW, Diabetes care
2019Randomized trialPMID 31530666DOIcites ClinicalTrials.gov:NCT02863328; registry reference RESULT:31530666
R005084654-OR: Oral Semaglutide vs. Empagliflozin Added On to Metformin Monotherapy in Uncontrolled Type 2 Diabetes: PIONEER 2
Eduard Montanya, Diabetes
2019Randomized trialDOIcites ClinicalTrials.gov:NCT02863328