Study S001496
A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
Registration
Registered primary outcomes
- Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]
Linked records (63)
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 |
|---|---|---|---|---|---|
| R0035390 | Improving the Efficiency of Subgroup Analysis in Randomized Controlled Trials with TMLE Sky Qiu, arXiv (Cornell University) | 2026 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| 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:NCT01179048; registry reference DERIVED:39963952 |
| R0016413 | Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease. Verma S, Diabetes, obesity & metabolism | 2022 | Other | PMID 35332654DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:35332654 |
| R0026225 | A higher non-severe hypoglycaemia rate is associated with an increased risk of subsequent severe hypoglycaemia and major adverse cardiovascular events in individuals with type 2 diabetes in the LEADER study. Heller SR, Diabetologia | 2022 | Randomized trial | PMID 34704120DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:34704120 |
| R0012296 | Evaluation of Consistency of Treatment Response Across Regions-the LEADER Trial in Relation to the ICH E17 Guideline. Nielsen HK, Frontiers in medicine | 2021 | Other trial | PMID 34136501DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0027428 | Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial. Persson F, Diabetes care | 2021 | Randomized trial | PMID 33504496DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:33504496 |
| R0047600 | FC 058THE IMPORTANCE OF ADDRESSING MULTIPLE RISK MARKERS IN TYPE 2 DIABETES: RESULTS FROM THE LEADER AND SUSTAIN 6 TRIALS Emilie H. Zobel, Nephrology Dialysis Transplantation | 2021 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0006154 | Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Verma S, Diabetes, obesity & metabolism | 2020 | Randomized trial | PMID 32744418DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:32744418 |
| R0006812 | The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Leiter LA, Diabetes, obesity & metabolism | 2020 | Other | PMID 32372454DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:32372454 |
| R0011982 | Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial. Buse JB, Diabetes care | 2020 | Other trial | PMID 32366578DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:32366578 |
| R0012692 | Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease. Mann JFE, Clinical journal of the American Society of Nephrology : CJASN | 2020 | Randomized trial | PMID 32132141DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:32132141 |
| R0012962 | Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure. Marso SP, Journal of the American College of Cardiology | 2020 | Randomized trial | PMID 32164886DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:32164886 |
| R0019976 | Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Verma S, Diabetes, obesity & metabolism | 2020 | Randomized trial | PMID 32643857DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:32643857 |
| R0024638 | Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial. Crowley MJ, Diabetes care | 2020 | Other trial | PMID 32647053DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:32647053 |
| R0024734 | Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920. Nauck MA, Diabetes care | 2020 | Randomized trial | PMID 31959650DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:31959650 |
| R0034582 | Joint Model of eGFR Slope: Data from LEADER in Patients with Type 2 Diabetes and High Risk of Cardiovascular Events Johannes F.E. Mann, Journal of the American Society of Nephrology | 2020 | Other trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0043360 | Neoplasms reported with liraglutide or placebo in people with type 2 diabetes: Results from the LEADER randomized trial M.A. Nauck, Carolina Digital Repository (University of North Carolina at Chapel Hill) | 2020 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0043973 | Hypoglycemia, cardiovascular outcomes, and death: The LEADER experience B. Zinman, Carolina Digital Repository (University of North Carolina at Chapel Hill) | 2020 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0044861 | The impact of liraglutide on diabetes-related foot ulceration and associated complications in patients with type 2 diabetes at high risk for cardiovascular events: Results from the LEADER trial R. Simpson, Carolina Digital Repository (University of North Carolina at Chapel Hill) | 2020 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0044882 | Cardiovascular risk reduction with liraglutide: An exploratory mediation analysis of the leader trial MARTIN LINDER, Carolina Digital Repository (University of North Carolina at Chapel Hill) | 2020 | Other trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0047322 | Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials Maria Sejersten Ripa, Carolina Digital Repository (University of North Carolina at Chapel Hill) | 2020 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| 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:NCT01179048 |
| R0049649 | The Importance of Addressing Multiple Risk Markers in Type 2 Diabetes: Results from the LEADER Trial Emilie H. Zobel, Journal of the American Society of Nephrology | 2020 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0053890 | Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials J.B. Buse, Carolina Digital Repository (University of North Carolina at Chapel Hill) | 2020 | Other trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0011044 | Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial. Tack CJ, Diabetes, obesity & metabolism | 2019 | Randomized trial | PMID 31282028DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:31282028 |
| R0011102 | Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network. Hinton W, Diabetes, obesity & metabolism | 2019 | Nonrandomized study | PMID 30900349DOI | registry reference BACKGROUND:30900349 |
| R0017025 | Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Verma S, Diabetes, obesity & metabolism | 2019 | Other trial | PMID 30851070DOI | cites ClinicalTrials.gov:NCT01179048; registry reference BACKGROUND:30851070 |
| R0024583 | Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Nauck MA, Diabetes care | 2019 | Randomized trial | PMID 31399438DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:31399438 |
| R0024688 | Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial. Verma S, JAMA cardiology | 2019 | Randomized trial | PMID 31721979DOI | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:31721979 |
| R0025377 | Health-related quality of life in people with type 2 diabetes participating in the LEADER trial. Nauck MA, Diabetes, obesity & metabolism | 2019 | Other trial | PMID 30260088DOI | registry reference RESULT:30260088 |
| R0025415 | Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled Trial. Gilbert MP, Annals of internal medicine | 2019 | Randomized trial | PMID 30508430DOI | registry reference RESULT:30508430 |
| R0043277 | LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ Buse, John, Carolina Digital Repository (University of North Carolina at Chapel Hill) | 2019 | Other trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0007117 | Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Wittbrodt ET, The American journal of managed care | 2018 | Nonrandomized study | PMID 29693361 | cites ClinicalTrials.gov:NCT01179048; registry reference DERIVED:29693361 |
| R0013052 | Cardiovascular outcomes in patients who experienced a myocardial infarction while treated with liraglutide versus placebo in the LEADER trial. Nauck MA, Diabetes & vascular disease research | 2018 | Randomized trial | PMID 29947247DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:29947247 |
| R0015703 | Effects of Liraglutide Versus Placebo on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease. Mann JFE, Circulation | 2018 | Randomized trial | PMID 30566006DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:30566006 |
| R0021336 | Effects of Liraglutide on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus With or Without History of Myocardial Infarction or Stroke. Verma S, Circulation | 2018 | Randomized trial | PMID 30566004DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:30566004 |
| R0024991 | Myocardial Infarction Subtypes in Patients With Type 2 Diabetes Mellitus and the Effect of Liraglutide Therapy (from the LEADER Trial). Marso SP, The American journal of cardiology | 2018 | Other trial | PMID 29627109DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:29627109 |
| R0025004 | No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in Response to Liraglutide for Up to 5 Years in the LEADER Trial. Hegedüs L, Diabetes care | 2018 | Randomized trial | PMID 29279300DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:29279300 |
| R0025075 | Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial. Nauck MA, Diabetes care | 2018 | Randomized trial | PMID 29898902DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:29898902 |
| R0025227 | The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial. Dhatariya K, Diabetes care | 2018 | Randomized trial | PMID 30072400DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:30072400 |
| R0025408 | Hypoglycemia, Cardiovascular Outcomes, and Death: The LEADER Experience. Zinman B, Diabetes care | 2018 | Randomized trial | PMID 29903847DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:29903847 |
| R0025563 | Liraglutide and Glycaemic Outcomes in the LEADER Trial. Zinman B, Diabetes therapy : research, treatment and education of diabetes and related disorders | 2018 | Other trial | PMID 30392095DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:30392095 |
| R0025668 | Liraglutide Reduces Cardiovascular Events and Mortality in Type 2 Diabetes Mellitus Independently of Baseline Low-Density Lipoprotein Cholesterol Levels and Statin Use. Verma S, Circulation | 2018 | Randomized trial | PMID 30354517DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:30354517 |
| R0025753 | Effect of Liraglutide on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Polyvascular Disease: Results of the LEADER Trial. Verma S, Circulation | 2018 | Randomized trial | PMID 29760228DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:29760228 |
| R0049483 | P2518Arrythmias and heart rate increase in the LEADER trial and relation to risk of cardiovascular events Mansoor Husain, European Heart Journal | 2018 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0049736 | Implications of cardiovascular outcome trials with injectable antidiabetic agents Richard E. Pratley, Journal of Diabetes | 2018 | Randomized trial | PMID 29971941DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0049824 | Liraglutide Effects in Insulin-Treated Patients in LEADER CORNELIS TACK, Diabetes | 2018 | Randomized trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0052766 | P2858Liraglutide reduces cardiovascular events and mortality in type 2 diabetes independent of LDL cholesterol and statin use: results of the LEADER trial Subodh Verma, European Heart Journal | 2018 | Other trial | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0021512 | Liraglutide and Renal Outcomes in Type 2 Diabetes. Mann JFE, The New England journal of medicine | 2017 | Randomized trial | PMID 28854085DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:28854085 |
| R0025434 | Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial. Steinberg WM, Diabetes care | 2017 | Randomized trial | PMID 28476871DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:28476871 |
| R0011428 | LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial. Petrie JR, Journal of hypertension | 2016 | Randomized trial | PMID 26855018DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:26855018 |
| R0022060 | Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. Marso SP, The New England journal of medicine | 2016 | Randomized trial | PMID 27295427DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:27295427 |
| R0027699 | LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial. Masmiquel L, Cardiovascular diabetology | 2016 | Other trial | PMID 26864124DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:26864124 |
| R0027910 | LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ. Rutten GE, Diabetology & metabolic syndrome | 2016 | Other trial | PMID 27274772DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:27274772 |
| R0048786 | LEADER-8: Patienten mit Typ 2 Diabetes mellitus und hohem kardiovaskulären Risiko: ein Vergleich ost- und westeuropäischer Teilnehmer in der LEADER Studie Edward Franek, Diabetologie und Stoffwechsel | 2016 | Other | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0049605 | LEADER-5: Prävalenz und kardiometabolischer Einfluss von Übergewicht und Adipositas bei kardiovaskulären Hochrisikopatienten mit Typ 2 Diabetes mellitus: Baseline-Daten aus der LEADER-Studie Simon N. Jacob, Diabetologie und Stoffwechsel | 2016 | Other | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0049931 | SGLT2 inhibitors: providing cardiovascular protection in type 2 diabetes? Raul Dias Santos | 2016 | Other trial | cites ClinicalTrials.gov:NCT01179048 | |
| R0052649 | LEADER-4: Blutdruckkontrolle bei Patienten mit Typ 2 Diabetes mellitus und hohem kardiovaskulären Risiko: Baseline-Daten aus der LEADER Studie Sylvia Jacob, Diabetologie und Stoffwechsel | 2016 | Other | DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0027226 | LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations. Daniels GH, Diabetes, obesity & metabolism | 2015 | Randomized trial | PMID 25656058DOI | registry reference RESULT:25656058 |
| R0027001 | LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial. Steinberg WM, Pancreas | 2014 | Randomized trial | PMID 25275271DOI | cites ClinicalTrials.gov:NCT01179048; registry reference RESULT:25275271 |
| R0048972 | Comment on Andersen et al, Pancreatitis–Diabetes–Pancreatic Cancer Alan Charles Moses, Pancreas | 2014 | Randomized trial | PMID 24713674DOI | cites ClinicalTrials.gov:NCT01179048 |
| R0027038 | Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Marso SP, American heart journal | 2013 | Randomized trial | PMID 24176437DOI | registry reference RESULT:24176437 |
| R0035682 | LEADER Study: Testing the Cardiovascular Safety of Liraglutide M. Mosley, MD Conference Express | 2013 | Other trial | DOI | cites ClinicalTrials.gov:NCT01179048 |