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Study · Randomized controlled trial · n = 792 · 2025

4 results

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 MP, Catarig AM, Houlind K, Ludvik B, Nordanstig J, Ramesh CK, Rasouli N, Sourij H, Videmark A, Verma S

Lancet (London, England)29 Mar 2025Cited by 102 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes and symptomatic peripheral artery disease, semaglutide increased the maximum walking distance on a treadmill at week 52 more than placebo.

    In plain wordsIn adults with type 2 diabetes and leg artery disease, semaglutide improved treadmill walking distance after 52 weeks more than placebo.

    Outcome
    IncreaseRatio to baseline of maximum walking distance at week 52
    Study

    n = 792

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Exercise and physical function · Cardiovascular
    Studied dose
    1.0 mg once per week · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment ratio
    1.13 ratio
    semaglutide vs placebo, week 52

    Source sentences

    Summary
    The estimated median ratio to baseline in maximum walking distance at week 52 was significantly greater in the semaglutide group than the placebo group (1·21 [IQR 0·95-1·55] vs 1·08 [0·86-1·36]; estimated treatment ratio 1·13 [95% CI 1·06-1·21]; p=0·0004).
    3 context sentences
    Summary · context
    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.
    Summary · context
    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.
    Summary · context
    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.
  2. 02HumanRandomized controlled trialSafety outcome

    Treatment-related serious adverse events occurred in five participants (1%) on semaglutide and six participants (2%) on placebo.

    In plain wordsSerious side effects linked to treatment were rare, in 1% of people on semaglutide and 2% on placebo.

    Outcome
    No significant changeTreatment-related serious adverse events
    Study

    n = 792

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.0 mg once per week · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Six serious adverse events in five (1%) participants in the semaglutide group and nine serious adverse events in six (2%) participants in the placebo group were possibly or probably treatment related
    2 context sentences
    Summary · context
    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.
    Summary · context
    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.
  3. 03HumanRandomized controlled trialSafety outcome

    Serious gastrointestinal events were the most frequent treatment-related serious events: two events in two participants (1%) on semaglutide and five events in three participants (1%) on placebo.

    In plain wordsSerious stomach and gut events linked to treatment were rare: 1% of people on semaglutide and 1% on placebo.

    Outcome
    No significant changeTreatment-related serious gastrointestinal events
    Study

    n = 792

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.0 mg once per week · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    with the most frequent being serious gastrointestinal events (two events reports by two [1%] in the semaglutide group and five events reported by three [1%] in the placebo group).
    2 context sentences
    Summary · context
    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.
    Summary · context
    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.
  4. 04HumanRandomized controlled trialSafety outcome

    There were no treatment-related deaths.

    In plain wordsNo deaths were linked to the treatment.

    Outcome
    No significant changeTreatment-related deaths
    Study

    n = 792

    Comparator
    Placebo
    Outcome group
    Mortality · Whole body
    Studied dose
    1.0 mg once per week · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no treatment-related deaths.
    2 context sentences
    Summary · context
    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.
    Summary · context
    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.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT04560998

A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

Novo Nordisk A/Sn = 7921 Oct 2020 to 12 Jul 2024

Diabetes Mellitus, Type 2 · Peripheral Arterial Disease

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 00:04 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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