Study S002025

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

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: NCT02827708
Acronym: PIONEER 5
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 324
Start: 2016-09-20
Primary completion: 2018-04-10
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:2015-005326-19; OTHER:U1111-1176-9230; NIH:2015

Registered primary outcomes

Change in HbA1c [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
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT02827708; registry reference DERIVED:39963952
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:NCT02827708
R0019127	Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Mosenzon O, Cardiovascular diabetology	2022	Randomized trial	PMID 36056351 DOI	cites ClinicalTrials.gov:NCT02827708; registry reference DERIVED:36056351
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:NCT02827708; 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:NCT02827708; 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:NCT02827708; 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:NCT02827708; registry reference DERIVED:31903692
R0021335	Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial. Mosenzon O, The lancet. Diabetes & endocrinology	2019	Randomized trial	PMID 31189517 DOI	cites ClinicalTrials.gov:NCT02827708; cites EudraCT:2015-005326-19; registry reference RESULT:31189517
R0054288	1004-P: Oral Semaglutide vs. Placebo in Patients with Type 2 Diabetes and Moderate Renal Impairment: PIONEER 5 Ofri Mosenzon, Diabetes	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02827708