Study S001741

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only.

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: NCT02906930
Acronym: PIONEER 1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 703
Start: 2016-09-20
Primary completion: 2017-10-30
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:2015-005622-19; OTHER:U1111-1177-5112; OTHER:JapicCTI-163384; NIH:2015

Registered primary outcomes

Change in HbA1c [Week 0, week 26]

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
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:NCT02906930; registry reference DERIVED:36056351
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
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
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:NCT02906930; 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:NCT02906930; 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:NCT02906930; registry reference DERIVED:31903692
R0018373	PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes. Aroda VR, Diabetes care	2019	Randomized trial	PMID 31186300 DOI	cites ClinicalTrials.gov:NCT02906930; registry reference RESULT:31186300
R0027467	Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: The PIONEER 1 randomized clinical trial as an example. Aroda VR, Diabetes, obesity & metabolism	2019	Randomized trial	PMID 31168921 DOI	registry reference BACKGROUND:31168921
R0028588	Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Kolotkin RL, Clinical obesity	2019	Randomized trial	PMID 30993900 DOI	cites ClinicalTrials.gov:NCT02906930; registry reference BACKGROUND:30993900
R0055149	Effect and Safety of Oral Semaglutide Monotherapy in Type 2 Diabetes—PIONEER 1 Trial Vanita R. Aroda, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02906930