Cardiovascular outcomes · Phase 3
LEADER: cardiovascular outcomes
What was tested?
Liraglutide versus placebo added to standard care in people with type 2 diabetes and high cardiovascular risk. ↗
Registered primary question: Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke. ↗
What the reviewed report found
Journal year 2016 · Article summary reviewed 2026-08-19
The primary composite cardiovascular outcome occurred in 13.0% of the liraglutide group and 14.9% of the placebo group, with a reported hazard ratio of 0.87. Gastrointestinal events were the most common events leading to discontinuation.↗
Keep in context: The reported median follow-up was 3.8 years. The study population had type 2 diabetes and high cardiovascular risk; it does not establish the same result in lower-risk populations. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 9,341 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Double
- Design
- Parallel
- Eligible ages
- 50 Years; maximum not specified
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2019-07-17; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
LEADER cardiovascular-outcomes trial
- Design in the report
- A double-blind, randomized, placebo-controlled cardiovascular-outcomes trial followed participants for a median of 3.8 years.↗
- Participants in the report
- The trial randomized 9,340 adults with type 2 diabetes and high cardiovascular risk in addition to standard care.↗
- Limitations
- The sponsor-funded findings apply to a high-cardiovascular-risk type 2 diabetes population receiving standard care and do not establish the same effect in lower-risk populations.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results ↗
Protocol identifier: EX2211-3748. Sponsor: Novo Nordisk A/S.
Retrieved 2026-09-20; SHA-256 8a335efbfff8122f74c28763c67a049097d0d5cd7a882f485cb8ed28aa4bda9c.
PMID 27295427
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes ↗
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 27295427. SHA-256 0e6795be99af1c93f3a3e2726fc8a17152661ca29e8dead110bff36feb856127.
Scientific summary uses the original 2026-08-19 source snapshot: SHA-256 d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26.