Study S002369

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)

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

Registration

Registration: NCT03021187
Acronym: PIONEER 8
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 731
Start: 2017-02-02
Primary completion: 2018-01-18
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:semaglutide; DRUG:placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2016-000988-16; OTHER:U1111-1180-3637; OTHER:JapicCTI-173508; NIH:2016

Registered primary outcomes

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

Linked records (9)

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:NCT03021187
R0037882	721-P: Insulin-Sparing Effects of Oral Semaglutide: An Analysis of PIONEER 8 Vanita R. Aroda, Diabetes	2022	Other trial	DOI	cites ClinicalTrials.gov:NCT03021187
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:NCT03021187; 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:NCT03021187; 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:NCT03021187; 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:NCT03021187; registry reference DERIVED:31903692
R0037754	956-P: Efficacy and Safety of Oral Semaglutide When Added to Basal, Premix, or Basal-Bolus Insulin Ofri Mosenzon, Diabetes	2020	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03021187
R0013053	Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Zinman B, Diabetes care	2019	Randomized trial	PMID 31530667 DOI	cites ClinicalTrials.gov:NCT03021187; registry reference RESULT:31530667
R0048616	985-P: Oral Semaglutide as Add-On to Insulin in T2D: PIONEER 8 Bernard Zinman, Diabetes	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03021187