Study S001381
A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)
Registration
Registered primary outcomes
- Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke [Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.]
Linked records (24)
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 39963952DOI | cites ClinicalTrials.gov:NCT02692716; registry reference DERIVED:39963952 |
| R0016776 | Effect of semaglutide versus placebo on cardiorenal outcomes by prior cardiovascular disease and baseline body mass index: Pooled post hoc analysis of SUSTAIN 6 and PIONEER 6. Zhou J, Diabetes, obesity & metabolism | 2025 | Other trial | PMID 40704485DOI | cites ClinicalTrials.gov:NCT02692716 |
| R0018274 | Cardiovascular, Metabolic, and Safety Outcomes with Semaglutide by Baseline Age: Post Hoc Analysis of SUSTAIN 6 and PIONEER 6. Bain SC, Diabetes therapy : research, treatment and education of diabetes and related disorders | 2025 | Other trial | PMID 39520501DOI | cites ClinicalTrials.gov:NCT02692716; registry reference DERIVED:39520501 |
| R0042126 | Effects of semaglutide on stroke subtypes in type 2 diabetes: post hoc analysis of the randomised SUSTAIN 6 & PIONEER 6 WD Strain (14423826), Figshare | 2025 | Randomized trial | cites ClinicalTrials.gov:NCT02692716 | |
| R0020454 | Semaglutide and cardiovascular outcomes by baseline HbA1c in diabetes: the SUSTAIN 6 and PIONEER 6 trials. Mellbin LG, European heart journal | 2024 | Nonrandomized study | PMID 38416593DOI | cites ClinicalTrials.gov:NCT02692716 |
| R0039098 | Effect of semaglutide on major adverse cardiovascular events by baseline kidney parameters in participants with type 2 diabetes and at high risk of cardiovascular disease: SUSTAIN 6 and PIONEER 6 post hoc pooled analysis Rossing, Peter, Figshare | 2024 | Other trial | DOI | cites ClinicalTrials.gov:NCT02692716 |
| R0020475 | Effect of semaglutide on major adverse cardiovascular events by baseline kidney parameters in participants with type 2 diabetes and at high risk of cardiovascular disease: SUSTAIN 6 and PIONEER 6 post hoc pooled analysis. Rossing P, Cardiovascular diabetology | 2023 | Other trial | PMID 37620807DOI | cites ClinicalTrials.gov:NCT02692716; registry reference DERIVED:37620807 |
| R0022330 | Semaglutide reduces the risk of major adverse cardiovascular events consistently across baseline triglyceride levels in patients with type 2 diabetes: Post hoc analyses of the SUSTAIN 6 and PIONEER 6 trials. Verma S, Diabetes, obesity & metabolism | 2023 | Randomized trial | PMID 37016488DOI | cites ClinicalTrials.gov:NCT02692716 |
| R0007143 | Semaglutide reduces cardiovascular events regardless of metformin use: a post hoc subgroup analysis of SUSTAIN 6 and PIONEER 6. Husain M, Cardiovascular diabetology | 2022 | Systematic review | PMID 35484580DOI | cites ClinicalTrials.gov:NCT02692716; registry reference RESULT:35484580 |
| R0010495 | Effects of Semaglutide on Stroke Subtypes in Type 2 Diabetes: Post Hoc Analysis of the Randomized SUSTAIN 6 and PIONEER 6. Strain WD, Stroke | 2022 | Randomized trial | PMID 35582947DOI | cites ClinicalTrials.gov:NCT02692716; registry reference DERIVED:35582947 |
| 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 35373893DOI | registry reference RESULT:35373893 |
| R0017715 | A population-adjusted indirect comparison of cardiovascular benefits of once-weekly subcutaneous semaglutide and dulaglutide in the treatment of patients with type 2 diabetes, with or without established cardiovascular disease. Evans LM, Endocrinology, diabetes & metabolism | 2021 | Randomized trial | PMID 34277983DOI | registry reference RESULT:34277983 |
| R0020208 | Applying REWIND cardiovascular disease criteria to SUSTAIN 6 and PIONEER 6: An exploratory analysis of cardiovascular outcomes with semaglutide. Verma S, Diabetes, obesity & metabolism | 2021 | Other trial | PMID 33606902DOI | cites ClinicalTrials.gov:NCT02692716; registry reference DERIVED:33606902 |
| R0052406 | 664-P: Incorporating Treatment Pauses, Dosing Flexibility, and Education to Support GLP-1RA Therapy Persistence Vanita R. Aroda, Diabetes | 2021 | Other trial | DOI | cites ClinicalTrials.gov:NCT02692716 |
| 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 32267058DOI | cites ClinicalTrials.gov:NCT02692716; 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 32998732DOI | cites ClinicalTrials.gov:NCT02692716; 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 31903692DOI | cites ClinicalTrials.gov:NCT02692716; registry reference DERIVED:31903692 |
| R0041631 | APPLYING REWIND CVD CRITERIA TO SUSTAIN 6 AND PIONEER 6: AN EXPLORATORY ANALYSIS OF CV OUTCOMES WITH SEMAGLUTIDE Subodh Verma, Journal of the American College of Cardiology | 2020 | Other trial | DOI | cites ClinicalTrials.gov:NCT02692716 |
| R0048083 | Estimating cardiovascular disease-free life-years with the addition of semaglutide in people with type 2 diabetes using pooled data from SUSTAIN 6 and PIONEER 6 Jan Westerink, European Heart Journal | 2020 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT02692716 |
| R0049018 | Abstract 13814: Semaglutide Reduces Mace Consistently Across Baseline Triglyceride Levels in Patients With Type 2 Diabetes: A Post Hoc Analysis of the Sustain 6 and Pioneer 6 Trials Subodh Verma, Circulation | 2020 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT02692716 |
| R0049459 | Effects of liraglutide and semaglutide on stroke subtypes in patients with type 2 diabetes: a post hoc analysis of the LEADER, SUSTAIN 6 and PIONEER 6 trials William David Strain, European Heart Journal | 2020 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT02692716 |
| R0013172 | Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: Rationale, design and patient baseline characteristics for the PIONEER 6 trial. Bain SC, Diabetes, obesity & metabolism | 2019 | Protocol | PMID 30284349DOI | registry reference RESULT:30284349 |
| R0013782 | Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. Husain M, The New England journal of medicine | 2019 | Randomized trial | PMID 31185157DOI | cites ClinicalTrials.gov:NCT02692716; registry reference RESULT:31185157 |
| R0028687 | Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum. Cefalu WT, Diabetes care | 2018 | Other trial | PMID 29263194DOI | registry reference RESULT:29263194 |