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Cited by 176Peripheral Artery Disease ManagementDiabetes Treatment and ManagementDiabetes, Cardiovascular Risks, and Lipoproteins

Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial

Bonaca, Marc P, Catarig, Andrei-Mircea, Houlind, Kim, Ludvik, Bernhard, Nordanstig, Joakim, Ramesh, Chethana Kalmady, Rasouli, Neda, Sourij, Harald +2 more·2025·The Lancet
DOI 10.1016/s0140-6736(25)00509-4
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Abstract

Background Peripheral artery disease is a highly morbid type of atherosclerotic vascular disease involving the legs and is estimated to affect over 230 million individuals globally. Few therapies improve functional capacity and health-related quality of life in people with lower limb peripheral artery disease. We aimed to evaluate whether semaglutide improves function as measured by walking ability as well as symptoms, quality of life, and outcomes in people with peripheral artery disease and type 2 diabetes. Methods STRIDE was a double-blind, randomised, placebo-controlled trial done at 112 outpatient clinical trial sites in 20 countries in North America, Asia, and Europe. Participants were aged 18 years and older, with type 2 diabetes and peripheral artery disease with intermittent claudication (Fontaine stage IIa, able to walk >200 m) and an ankle-brachial index of less than or equal to 0·90 or toe-brachial index of less than or equal to 0·70. Participants were randomly assigned (1:1) using an interactive web response system to receive subcutaneous semaglutide 1·0 mg once per week for 52 weeks or placebo. The primary endpoint was the ratio to baseline of the maximum walking distance at week 52 measured on a constant load treadmill in the full analysis set. Safety was evaluated in the safety analysis set. This trial is registered with ClinicalTrials.gov, NCT04560998 and is now completed. Findings From Oct 1, 2020, to July 12, 2024, 1363 patients were screened for eligibilit…

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  • Recent clinical trial evidence supports a symptomatic benefit of GLP-1 RA in people with diabetes and PAD.

    “or the initiation of GLP-1 RA, as recent clinical trial evidence supports a symptomatic benefit of GLP-1 RA in people with diabetes and PAD (235).”

    From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [235]

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Authors
Bonaca, M. P., Catarig, A.-M., Houlind, K., Ludvik, B., Nordanstig, J., Ramesh, C. K., Rasouli, N., Sourij, H., Videmark, A., & Verma, S.
Affiliations
  • University of Colorado Anschutz (US)
  • Novo Nordisk (Denmark) (DK)
  • University of Southern Denmark (DK)
  • University of Gothenburg (SE)
  • Novo Nordisk (India) (IN)
  • Medical University of Graz (AT)
  • St. Michael's Hospital (CA)
Corresponding author
Bonaca, Marc P
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2025-05
Volume
405
Issue
10489
Pages
1580-1593
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(25)00509-4
OpenAlex
W4408991563
Cited by
176
References
5
Citations by year
2026: 125 · 2025: 51
FWCI
164.08
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
Funders
Novo Nordisk AS
Topics
  • Health Sciences › Medicine › Surgery › Peripheral Artery Disease Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
semaglutide, peripheral arterial disease, type 2 diabetes, intermittent claudication, walking capacity, maximum walking distance, GLP-1 receptor agonists, ankle-brachial index, health-related quality of life, ankle pain, ankle swelling, adverse events, STRIDE trial, atherosclerosis, treadmill walking test, toe-brachial index
MeSH terms
Glucagon-Like Peptide-1 Receptor Agonists, Semaglutide, Aged, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Humans, Intermittent Claudication, Male, Middle Aged, Quality of Life, Walking, Treatment Outcome, Glucagon-Like Peptide 1, Ankle Brachial Index, Peripheral Arterial Disease

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