Study S001153

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus

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

Registration

Registration: NCT02849080
Acronym: PIONEER 7
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 504
Start: 2016-09-20
Primary completion: 2018-02-28
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:semaglutide; DRUG:sitagliptin
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2015-005593-38; OTHER:U1111-1177-5103; NIH:2015

Registered primary outcomes

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) [Week 52]

Linked records (10)

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:NCT02849080
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
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:NCT02849080; registry reference DERIVED:33660198
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:NCT02849080; 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:NCT02849080; 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:NCT02849080; registry reference DERIVED:31903692
R0023369	Long-term efficacy and safety of oral semaglutide and the effect of switching from sitagliptin to oral semaglutide in patients with type 2 diabetes: a 52-week, randomized, open-label extension of the PIONEER 7 trial. Buse JB, BMJ open diabetes research & care	2020	Randomized trial	PMID 33318068 DOI	cites ClinicalTrials.gov:NCT02849080; registry reference RESULT:33318068
R0046810	Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial J.C. LaRocque, Carolina Digital Repository (University of North Carolina at Chapel Hill)	2020	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02849080; cites EudraCT:2015-005593-38
R0020392	Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial. Pieber TR, The lancet. Diabetes & endocrinology	2019	Randomized trial	PMID 31189520 DOI	cites ClinicalTrials.gov:NCT02849080; cites EudraCT:2015-005593-38; registry reference RESULT:31189520
R0050695	983-P: Effect and Safety of Flexible Dose Adjustment with Oral Semaglutide vs. Sitagliptin in Type 2 Diabetes: PIONEER 7 John B. Buse, Diabetes	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02849080