Cardiovascular outcomes · Phase 3
EXSCEL: cardiovascular safety and efficacy
What was tested?
Extended-release exenatide versus placebo alongside usual care in people with type 2 diabetes. ↗
Registered primary question: Time to the first major cardiovascular event, tested for both safety noninferiority and efficacy superiority. ↗
What the reviewed report found
Journal year 2017 · Article summary reviewed 2026-08-19
The primary cardiovascular outcome occurred in 11.4% of the exenatide group and 12.2% of the placebo group. The comparison met noninferiority for safety but not superiority for efficacy.↗
Keep in context: The safety noninferiority criterion was met, but the superiority criterion for reducing cardiovascular events was not. Those are different questions. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 14,752 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Triple
- Design
- Parallel
- Eligible ages
- 18 Years to 130 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2018-08-08; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
EXSCEL cardiovascular-outcomes trial
- Design in the report
- A sponsor-funded randomized placebo-controlled cardiovascular-outcomes trial followed participants for a median of 3.2 years alongside usual care.↗
- Participants in the report
- The trial randomized 14,752 adults with type 2 diabetes; 73.1% had previous cardiovascular disease.↗
- Limitations
- The pragmatic trial included participants with and without prior cardiovascular disease, and its borderline superiority result should not be reframed as proof of cardiovascular benefit.↗
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
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus ↗
Protocol identifier: D5551C00003. Sponsor: AstraZeneca.
Retrieved 2026-09-20; SHA-256 1356baa2d4803e5af4fc098e707e1b1db863dc03f8209d742f5091dc0721fefa.
PMID 28910237
Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes ↗
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. 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 28910237. SHA-256 0e6795be99af1c93f3a3e2726fc8a17152661ca29e8dead110bff36feb856127.
Scientific summary uses the original 2026-08-19 source snapshot: SHA-256 63ec335a3a836425cbeda76243629bf58816c0c94abb17e82892e75e64dd09ce.