- Question
- Does semaglutide improve walking capacity in patients with symptomatic peripheral artery disease and type 2 diabetes?
- Design
- Phase 3b, double-blind, 1:1 randomised, placebo-controlled trial conducted at 112 outpatient sites in 20 countries across North America, Asia and Europe. A total of 792 patients were randomised and treated for 52 weeks.
- Population
- Adults aged 18 years or older with type 2 diabetes and peripheral artery disease with intermittent claudication (Fontaine IIa, able to walk more than 200 m), with an ankle-brachial index ≤0.90 or toe-brachial index ≤0.70. Median age was 68.0 years and 75% were men.
- Intervention
- Subcutaneous semaglutide 1.0 mg once weekly for 52 weeks, added to standard of care.
- Control
- Weekly subcutaneous placebo for 52 weeks, added to standard of care.
- Primary outcome
- Ratio to baseline of maximum walking distance at week 52, measured on a constant-load treadmill.
- Results
- The estimated median ratio to baseline was 1.21 with semaglutide vs 1.08 with placebo; estimated treatment ratio 1.13 (95% CI 1.06-1.21; p=0.0004).
- Safety
- Serious adverse events possibly or probably treatment related were uncommon: 6 events in 5 participants (1%) with semaglutide and 9 events in 6 participants (2%) with placebo, mostly gastrointestinal. There were no treatment-related deaths.
- Conclusion
- Semaglutide increased walking distance in patients with symptomatic peripheral artery disease and type 2 diabetes.
- Why it matters
- It provided evidence for a drug therapy that improves functional capacity in claudication, an area with few therapeutic options. Efficacy and safety in patients without type 2 diabetes remain to be defined.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026