Study S002267

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin 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/

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02607865
Acronym: PIONEER 3
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 1864
Start: 2016-02-15
Primary completion: 2017-02-14
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:semaglutide; DRUG:sitagliptin; DRUG:placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2015-001351-71; OTHER:U1111-1168-4339; OTHER:JAPIC; NIH:2015

Registered primary outcomes

Change in HbA1c: Week 26 [Week 0, week 26]

Linked records (13)

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
R0048770	Oral 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)	2024	Other trial	DOI	cites ClinicalTrials.gov:NCT02607865
R0020952	Cost-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	2023	Nonrandomized study	PMID 37178435 DOI	cites ClinicalTrials.gov:NCT02607865; registry reference DERIVED:37178435
R0021795	Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Aroda VR, Diabetes, obesity & metabolism	2022	Other trial	PMID 35373893 DOI	registry reference RESULT:35373893
R0022514	Long-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	2022	Nonrandomized study	PMID 35064550 DOI	cites ClinicalTrials.gov:NCT02607865; registry reference RESULT:35064550
R0012356	Oral 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	2021	Other trial	PMID 33660198 DOI	cites ClinicalTrials.gov:NCT02607865; registry reference DERIVED:33660198
R0020297	Efficacy 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	2021	Randomized trial	PMID 34472698 DOI	registry reference RESULT:34472698
R0045784	Oral Semaglutide vs. Sitagliptin: Efficacy by Baseline HbA1c and Background OAD in PIONEER 3 Michelle E. Hauser, Diabetologie und Stoffwechsel	2021	Other	DOI	cites ClinicalTrials.gov:NCT02607865
R0007971	Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Thethi TK, Diabetes, obesity & metabolism	2020	Randomized trial	PMID 32267058 DOI	cites ClinicalTrials.gov:NCT02607865; registry reference DERIVED:32267058
R0018529	Effects 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	2020	Randomized trial	PMID 32998732 DOI	cites ClinicalTrials.gov:NCT02607865; registry reference DERIVED:32998732
R0018857	Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Husain M, Diabetes, obesity & metabolism	2020	Other	PMID 31903692 DOI	cites ClinicalTrials.gov:NCT02607865; registry reference DERIVED:31903692
R0015588	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. Rosenstock J, JAMA	2019	Randomized trial	PMID 30903796 DOI	cites ClinicalTrials.gov:NCT02607865; registry reference RESULT:30903796
R0044140	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. J Rosenstock (7710920), Figshare	2019	Randomized trial		cites ClinicalTrials.gov:NCT02607865
R0045615	111-LB: Oral Semaglutide vs. Sitagliptin: Efficacy by Baseline HbA1c and Background OAD in PIONEER 3 Julio Rosenstock, Diabetes	2019	Other	DOI	cites ClinicalTrials.gov:NCT02607865