# LEADER: liraglutide and cardiovascular events in type 2 diabetes Study · id `cardio:leader-trial` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: LEADER Browse, organ or system: Metabolism Browse, condition area: Diabetes and metabolic disease ## In plain language A large trial of people with type 2 diabetes at high risk of heart and blood-vessel disease. Half took liraglutide and half took placebo, both on top of usual care. Fewer people on liraglutide had the combined event of a heart attack, a stroke or a heart-related death, and fewer died from any cause. Stomach and bowel side effects were the most common reason for stopping liraglutide. ## Technical summary Double-blind randomized trial sponsored by Novo Nordisk (NCT01179048). The primary hypothesis was noninferiority of liraglutide to placebo for the first death from cardiovascular causes, nonfatal myocardial infarction or nonfatal stroke (margin 1.30 for the upper boundary of the 95% CI); 608 of 4668 patients on liraglutide and 694 of 4672 on placebo had the outcome (hazard ratio 0.87, 95% CI 0.78 to 0.97). Median follow-up 3.8 years. The registry counts 9341 enrolled; the paper reports 9340 randomized. ## Key facts - Design: Multicenter, international, randomized, double-blind, placebo-controlled trial with parallel groups (registry official title). The registry records phase 3 and double masking. - Phase: Phase 3 - Enrolled: 9341 participants (enrolled count; Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results, snapshot `cardio:ctgov-nct01179048-2026-10-14`, retrieved 2026-10-14); 9340 patients (randomized count; Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes, snapshot `cardio:pubmed-27295427-2026-10-14`, retrieved 2026-10-14) - Started: 2010-08-31 (actual) (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results, snapshot `cardio:ctgov-nct01179048-2026-10-14`, retrieved 2026-10-14) - Primary completion: 2015-12-17 (actual) (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results, snapshot `cardio:ctgov-nct01179048-2026-10-14`, retrieved 2026-10-14) - Completion: 2015-12-17 (actual) (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results, snapshot `cardio:ctgov-nct01179048-2026-10-14`, retrieved 2026-10-14) - Results first posted: 2017-03-01 (actual) (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results, snapshot `cardio:ctgov-nct01179048-2026-10-14`, retrieved 2026-10-14) - Countries: United States; Australia; Austria; Belgium; Brazil; Canada; China; Czechia; Denmark; Finland; France; Germany; Greece; India; Ireland; Israel; Italy; Mexico; Netherlands; Norway; Poland; Puerto Rico; Romania; Russia; Serbia; South Africa; South Korea; Spain; Sweden; Taiwan; United Arab Emirates; United Kingdom; Türkiye (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results, snapshot `cardio:ctgov-nct01179048-2026-10-14`, retrieved 2026-10-14) - Care setting: Not reported - Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct01179048-2026-10-14`, retrieved 2026-10-14) ## Claims, with the population each applies to ## Context: Adults with type 2 diabetes and high cardiovascular risk (LEADER) Recipient: Adult; Population: Patients with type 2 diabetes and high cardiovascular risk. The registry gives a minimum age of 50 years.; Care setting: Multicenter, international trial (registry official title). The care setting is not described further in the sources read.; Geography: Multinational. The registry lists the sites by country on the study page.; Life stage: Patients aged 50 years or older (registry minimum age 50 years); Follow-up: Median follow-up 3.8 years. ### In LEADER, patients with type 2 diabetes and high cardiovascular risk were randomly assigned to liraglutide or placebo in addition to standard care. Over a median of 3.8 years, a first death from cardiovascular causes, nonfatal heart attack or nonfatal stroke occurred in 608 of 4668 patients (13.0%) on liraglutide and 694 of 4672 (14.9%) on placebo (hazard ratio 0.87, 95% CI 0.78 to 0.97; P<0.001 for noninferiority; P=0.01 for superiority). Death from cardiovascular causes was lower, in 219 patients (4.7%) against 278 (6.0%) (hazard ratio 0.78, 95% CI 0.66 to 0.93), and so was death from any cause, in 381 (8.2%) against 447 (9.6%) (hazard ratio 0.85, 95% CI 0.74 to 0.97). Nonfatal heart attack, nonfatal stroke and hospitalization for heart failure were lower in the liraglutide group, but not by a significant margin. Gastrointestinal events were the most common adverse events that led to stopping liraglutide. - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: Recipient: Adult; Population: Patients with type 2 diabetes and high cardiovascular risk. The registry gives a minimum age of 50 years.; Care setting: Multicenter, international trial (registry official title). The care setting is not described further in the sources read.; Geography: Multinational. The registry lists the sites by country on the study page.; Life stage: Patients aged 50 years or older (registry minimum age 50 years); Follow-up: Median follow-up 3.8 years. - Limitations: The primary hypothesis was noninferiority of liraglutide to placebo, with a margin of 1.30; superiority was tested afterwards. The abstract says no adjustment for multiplicity was made for the prespecified exploratory outcomes. The registry counts 9341 enrolled and the paper 9340 randomized, a difference this atlas does not reconcile. Funded by Novo Nordisk and the National Institutes of Health (abstract). Only the PubMed abstract was read; the PMC copy is not in the open-access subset. - Last checked: 2026-10-14 - Sources: 1. Supports: Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:48Z. Source state: Current. Snapshot hash: d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26. How it applies: Primary outcome counts by arm, hazard ratio and the noninferiority and superiority p-values. 2. Supports: Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, RESULTS, sentence 4; Abstract, RESULTS, sentence 5. Retrieved 2026-10-14T18:18:48Z. Source state: Current. Snapshot hash: d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26. How it applies: Cardiovascular death and all-cause death. 3. Supports: Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, RESULTS, sentence 6; Abstract, RESULTS, sentence 7; Abstract, RESULTS, sentence 8. Retrieved 2026-10-14T18:18:48Z. Source state: Current. Snapshot hash: d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26. How it applies: Outcomes that were not significantly different, and adverse events. 4. Supports: Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, RESULTS, sentence 1; Abstract, RESULTS, sentence 2. Retrieved 2026-10-14T18:18:48Z. Source state: Current. Snapshot hash: d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26. How it applies: Number randomized and median follow-up. 5. Background: Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, METHODS, sentence 1; Abstract, METHODS, sentence 2; Abstract, METHODS, sentence 3; Abstract, METHODS, sentence 4. Retrieved 2026-10-14T18:18:48Z. Source state: Current. Snapshot hash: d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26. How it applies: Design, primary outcome, noninferiority margin and multiplicity. 6. Background: Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, CONCLUSIONS, sentence 1; Abstract, CONCLUSIONS, sentence 2. Retrieved 2026-10-14T18:18:48Z. Source state: Current. Snapshot hash: d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26. How it applies: Conclusion and funding line. ## Connected pages - Lists type 2 diabetes as a condition: Type 2 diabetes (`cardio:type-2-diabetes`) - Tests liraglutide, a member of the class; the class has no separate liraglutide record: GLP-1 receptor agonists (drug class) (`cardio:glp1-receptor-agonists`) - Lead sponsor: Novo Nordisk (`cardio:novo-nordisk`) ## Provenance Content hash: 2ef40aaa28753b17151ff7e6d281176b953461a6809fa647d59cec52dcddb0c2 Last substantive edit: 2026-10-14 Evidence last checked: Not recorded