A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
STRIDE
Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
3 other identifiers
interventional
792
21 countries
194
Brief Summary
This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Oct 2020
Longer than P75 for phase_3 diabetes-mellitus-type-2
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2024
CompletedResults Posted
Study results publicly available
July 8, 2025
CompletedDecember 12, 2025
November 1, 2025
3.7 years
September 18, 2020
June 3, 2025
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Maximum Walking Distance on a Constant Load Treadmill Test
Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Baseline (week 0), end of treatment (week 52)
Secondary Outcomes (15)
Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test
Baseline (week 0), end of follow-up (week 57)
Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score
Baseline (week 0), end of treatment (week 52)
Change in Pain-free Walking Distance on a Constant Load Treadmill Test
Baseline (week 0), end of treatment (week 52)
Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test
Baseline (week 0), end of follow-up (week 57)
Change in Glycosylated Haemoglobin (HbA1c)
Baseline (week 0), end of treatment (week 52)
- +10 more secondary outcomes
Study Arms (2)
Semaglutide
EXPERIMENTALSemaglutide given in addition to standard-of-care treatment
Placebo (semaglutide)
PLACEBO COMPARATORPlacebo given in addition to standard-of-care treatment
Interventions
Semaglutide is administered subcutaneously (s.c.; under the skin) once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.
Placebo (semaglutide) is administered s.c. once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.
Eligibility Criteria
You may qualify if:
- Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan: Male or female, age above or equal to 20 years at time of signing informed consent
- Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
- Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following:
- Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview.
- Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.
- Screening constant load treadmill test with fixed inclination of 12% and a fixed speed of 3.2 km/h (2 mph): Walking distance equal to or less than 600 meters/1968 feet.
- Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.7 (the leg with lowest index is chosen in case of bilateral disease).
You may not qualify if:
- Current or previous treatment with any GLP-1 receptor agonist (GLP-1-RA) within 90 days prior to the day of screening.
- Walking ability limited by conditions other than PAD (e.g. aortic aneurism, dysregulated arrhythmia or hypertension, angina pectoris, heart failure, chronic obstructive or restrictive pulmonary disease, Parkinson's disease, severe peripheral neuropathy, amputations, wheel chair or walker dependency, osteoarthritis, morbid obesity, severe varicose veins, etc.).
- Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability).
- Vascular revascularisation procedure of any kind 180 days prior to the day of screening.
- Planned arterial revascularisation known on the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening.
- Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (194)
Cardiology, PC
Birmingham, Alabama, 35211, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205, United States
Cardio Innovation & Resch Ctr
Long Beach, California, 90813, United States
Angel City Research, Inc.
Los Angeles, California, 90010, United States
St. Joseph Heritage Healthcare_Mission Viejo
Mission Viejo, California, 92691, United States
Rocky Mount Reg VA Med-DN
Aurora, Colorado, 80045, United States
Univ of Colorado at Denver
Aurora, Colorado, 80045, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, 33511, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216, United States
DMI Research
Pinellas Park, Florida, 33782, United States
University of South Florida
Tampa, Florida, 33606, United States
Accel Research Site-Georgia
Eatonton, Georgia, 31024, United States
Reg Infectious Dis Infuse Ctr
La Grange, Georgia, 30240, United States
Aiyan Diabetes Center
Martinez, Georgia, 30907, United States
Endeavor Health Glenbook Hosp
Glenview, Illinois, 60026, United States
Central IL Diabetes and Clinical Research
Springfield, Illinois, 62701, United States
Cardiovascular Rsrch of NW_IN
Munster, Indiana, 46321, United States
Central Cardio Assoc HPS
Elizabethtown, Kentucky, 42701, United States
Cambridge Medical Trials
Alexandria, Louisiana, 71301, United States
LOUISIANA HEART Center
Covington, Louisiana, 70433, United States
Clinical Trials of Ame, LLC
Monroe, Louisiana, 71201, United States
Ascension Saint Agnes Heart Ca
Baltimore, Maryland, 21229, United States
Boston Medical Center_Cary
Boston, Massachusetts, 02118, United States
Minneapolis Cardiology Assoc
Minneapolis, Minnesota, 55407-1195, United States
Amicis Centers of Clinical Research
St Louis, Missouri, 63128, United States
Nebraska West Iowa Hlth System
Omaha, Nebraska, 68105, United States
Methodist Phys Clin Heart Cons
Omaha, Nebraska, 68114, United States
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03766, United States
NYU Langone Med Assoc Chelsea
New York, New York, 10001, United States
Accellacare_NC
Wilmington, North Carolina, 28401, United States
Capital Area Research LLC
Camp Hill, Pennsylvania, 17011, United States
Penn Presb Med Ctr
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt U Med Ctr_Nashville
Nashville, Tennessee, 37232, United States
PharmaTex Research
Amarillo, Texas, 79106, United States
Northwest Houston Cardiology, P.A.
Houston, Texas, 77070, United States
Houston Heart & Vascular Associates
Humble, Texas, 77338, United States
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339, United States
Texas Tech University Health Science Center
Lubbock, Texas, 79430-8183, United States
North Dallas Research Associates
McKinney, Texas, 75069, United States
Victoria Heart and Vasc Ctr
Victoria, Texas, 77901, United States
Selma Medical Associates
Winchester, Virginia, 22601-3834, United States
Universitätsklinik für Innere Medizin Graz
Graz, 8036, Austria
Univ.-Klinik für Innere Medizin III
Innsbruck, 6020, Austria
Klinik Landstraße
Vienna, 1030, Austria
AKH Wien
Vienna, 1090, Austria
Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery
Bonheiden, 2820, Belgium
Ziekenhuis Oost-Limburg AV - Thoracic
Genk, 3600, Belgium
UZ Gent - Thoracale Vasculaire Heelkunde
Ghent, 9000, Belgium
UZ Gent_Gent_1
Ghent, 9000, Belgium
AZ Groeninge - Thoracic Vascular Surgery
Kortrijk, 8500, Belgium
UZ Leuven - Hart en Vaatziekten
Leuven, 3000, Belgium
North York Diagn & Cardiac Ctr
North York, Ontario, M6B 3H7, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7, Canada
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
ViaCar Recherche Clinique Inc
Brossard, Quebec, J4Z 2K9, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Clinique Sante Cardio MC
Montreal, Quebec, H1T 3Y7, Canada
Montreal Heart Institute
Montreal, Quebec, QC H1T 1C8, Canada
CISSS des Laurentides
Saint-Jérôme, Quebec, J7Z 5T3, Canada
CHU de Quebec-Universite Laval
Québec, G1L 3L5, Canada
Institut universitaire de cardiologie
Québec, G1V 4G5, Canada
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Jilin, 130061, China
The first hospital of Jilin University
Changchun, Jilin, 130061, China
1st Affiliated Hosp of Xi'an JiaoTong Uni Medical College
Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xi'an JiaoTong University-Cardiovascular
Xi'an, Shaanxi, 710061, China
Tianjin Union Medical Center-Cardiology
Tianjin, 300121, China
Tianjin Union Medicine Centre
Tianjin, 300121, China
CTC Hodonin s.r.o.
Hodonín, 695 01, Czechia
EDUMED Jaromer
Jaroměř, 55101, Czechia
Kucera
Ostrava Dubina, 700 30, Czechia
Diabetologicka ambulance Plzen
Pilsen, 30100, Czechia
II. interni klinika - klinika kardiologie a angiologie 1. LF
Prague, 128 08, Czechia
Kolding Sygehus Karkirurgi
Kolding, 6000, Denmark
Rigshospitalet Karkirurgisk afd. RK 3111
København Ø, 2100, Denmark
Hjerte-, Lunge- og Karkirurgisk afdeling T
Odense, 5000, Denmark
Regionshospitalet Viborg - Karkirurgisk Afsnit
Viborg, 8800, Denmark
Kardiologische Praxis
Bad Homburg, 61348, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Kreutzmann
Dresden, 01277, Germany
Uniklinik TU Dresden - Med. Klinik und Poliklinik III Angiologie
Dresden, 01307, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, 60389, Germany
Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, 23538, Germany
Universitätsmedizin der JGU Mainz - Kardiologie I
Mainz, 55131, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145, Germany
Gemeinschaftspraxis Haggenmiller/Jeserich
Nuremberg, 90402, Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386, Germany
University Hospital of Athens ATTIKON
Athens, Attica, 12462, Greece
"Laiko" General Hospital of Athens
Athens, 11527, Greece
Konstantopouleio G.H. of Athens, "Agia Olga"
Athens, 14233, Greece
"Hygeia" General Hospital of Athens
Athens, 15123, Greece
General Hospital of Chios "Skilitsio" - Cardiology Clinic
Chios, 82100, Greece
General Hospital of Lamia
Lamia, 35100, Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, 54642, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, 57010, Greece
Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia
Szeged, Csongrád-Csanád, 6725, Hungary
Léda Platán Magánklinika
Zalaegerszeg, Zala County, 8900, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest, 1032, Hungary
Szent Imre Egyetemi Oktatókórház Angiológia
Budapest, 1115, Hungary
Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
Budapest, 1122, Hungary
Coromed SMO Kft.
Pécs, 7623, Hungary
Sanjeevani Superspeciality Hospital
Ahmedabad, Gujarat, 380015, India
Shri B D Mehta Mahavir Heart Institute
Surat, Gujarat, 395001, India
Shri B. D. Mehta Mahavir Heart Institute
Surat, Gujarat, 395001, India
Shri Krishna Hrudayalaya & Critical Care Centre
Nagpur, Maharashtra, 440012, India
Shrikrishna Hrudayalaya and critical care centre
Nagpur, Maharashtra, 440012, India
Vijan Hospital & Research Centre
Nashik, Maharashtra, 422005, India
VMMC & Safdarjung Hospital
New Dehli, New Delhi, 110029, India
SP Medical College
Bikaner, Rajasthan, 334003, India
Osmania General Hospital
Hyderabad, Telangana, 500012, India
Udyaan Health Care
Lucknow, Uttar Pradesh, 226002, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
New Tokyo Heart Clinic_Matsudo-shi, Chiba,
Chiba, 271-0077, Japan
Akaicho Clinic
Chiba-shi, Chiba, 260-0804, Japan
Takahashi Hospital_Cardiology
Hyōgo, 654-0026, Japan
Higashi Takarazuka Satoh Hospital_Cardiology
Hyōgo, 665-0873, Japan
Higashi Takarazuka Satoh Hospital
Hyōgo, 665-0873, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
Naka Kinen Clinic
Ibaraki, 311-0113, Japan
Nishiyamado Keiwa Hospital_Internal Medicine
Ibaraki, 331-0133, Japan
Omihachiman Community Medical Center_Omihachiman-shi, Siga
Omihachiman-shi, Siga, 523-0082, Japan
Minamiosaka Hospital_Internal medicine
Osaka, 559-0012, Japan
Saitama Cardiovascular and Respiratory Center
Saitama, 360-0197, Japan
Omi Medical Center_Cardiovascular Medicine
Shiga, 525-8585, Japan
Omi Medical Center
Shiga, 525-8585, Japan
Minamino Cardiovascular Hospital_Cardiovascular medicine
Tokyo, 192-0918, Japan
Stradini PAD
Riga, LV-1002, Latvia
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
University Technology MARA (UiTM) - Sg Buloh
Sungai Buloh, Selangor, 47000, Malaysia
National Heart Institute
Kuala Lumpur, 50400, Malaysia
Hospital Queen Elizabeth II
Sabak Bernam, 88300, Malaysia
Haukeland universitetssykehus - Karkirurgisk avdeling
Bergen, 5021, Norway
Sørlandet sykehus HF Kristiansand
Kristiansand, 4615, Norway
OUS, Aker
Oslo, 0586, Norway
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261, Poland
UniCardia & UniMedica & UniEstetica
Krakow, 31-271, Poland
Centrum Medyczne OMEDICA
Poznan, 60-111, Poland
Velocity Nova Sp. z o.o.
Puławy, 24-100, Poland
Gabinety Lekarskie LabMed
Szczecin, 71-531, Poland
Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego
Warsaw, 04-628, Poland
DoktorA
Warsaw, 05-077, Poland
Centrum Badan Klinicznych
Wroclaw, 51-162, Poland
Multispecialty Medical Clinic Anturium LLC
Barnaul, 656043, Russia
Road Clinical Hospital at station Chelyabinsk
Chelyabinsk, 454048, Russia
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk, 664049, Russia
Limited Liability Company "Alliance Biomedical Ural Group"
Izhevsk, 426061, Russia
SRMC "Your Health" LLC
Kazan', 420097, Russia
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, 117292, Russia
Federal Bureau for Medical and Social Expertise
Moscow, 127486, Russia
Pirogov Russian National Research Medical University MoH
Moscow, 129226, Russia
LLC RC Medical
Novosibirsk, 630005, Russia
SGIoH of Novosibirsk region "CC Hospital #19"
Novosibirsk, 630068, Russia
State Novosibirsk regional clinical hospital
Novosibirsk, 630087, Russia
LLC "Clinical diagnostic center Ultramed"
Omsk, 644024, Russia
Ryazan State Medical University
Ryazan, 390026, Russia
Joint Stock Company "Polyclinic Complex"
Saint Petersburg, 190013, Russia
Limited Liability Company "Clinic" MEDINEF "
Saint Petersburg, 194044, Russia
Limited Liability Company "Energiya Zdoroviya"
Saint Petersburg, 194156, Russia
SGHI "Polyclinic #106"
Saint Petersburg, 198328, Russia
Regional clinical cardiology dispensary
Saratov, 410028, Russia
SHI Saratov City Clinical Hospital #9
Saratov, 410031, Russia
Voronezh Regional Clinical Consultive-diagnostic Centre
Voronezh, 394018, Russia
Polyclinic #2 in Yoshkar-Ola
Yoshkar-Ola, 424004, Russia
Centro Periférico de Especialidades Bola Azul
Almería, 04009, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Gregorio Marañón
Madrid, 28009, Spain
Hospital Civil de Málaga
Málaga, 29009, Spain
Hospital Virgen de la Macarena
Seville, 41009, Spain
Hospital Vithas Sevilla
Seville, 41950, Spain
Kärlkirurgen/kärllab
Gothenburg, 413 45, Sweden
Kärlmottagningen
Uppsala, 751 85, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Kuang Tien General Hospital
Taichung, 433, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital_main
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan District, 333, Taiwan
Srinagarind Hospital
Muang, Changwat Khon Kaen, 40002, Thailand
King Chulalongkorn Memorial Hospital, Cardiology department
Bangkok, 10330, Thailand
Phramongkutklao Hospital-cardio
Bangkok, 10400, Thailand
Research Institute for Health Sciences, CMU
Chiang Mai, 50200, Thailand
Rihes - Research Institute for Health Sciences
Chiang Mai, 50200, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Maharat Nakhon Ratchasima Hospital_Ratchasima
Nakhon Ratchasima, 30000, Thailand
Maharat Nakhon Ratchasima Hospital_
Nakhon Ratchasima, 30000, Thailand
Thammasat University Hospital_Pathumthani
Pathum Thani, 12120, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Related Publications (1)
Bonaca MP, Catarig AM, Houlind K, Ludvik B, Nordanstig J, Ramesh CK, Rasouli N, Sourij H, Videmark A, Verma S; STRIDE Trial Investigators. 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. Lancet. 2025 May 3;405(10489):1580-1593. doi: 10.1016/S0140-6736(25)00509-4. Epub 2025 Mar 29.
PMID: 40169145DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Reporting Office (2834)
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Clinical Transparency (1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2020
First Posted
September 23, 2020
Study Start
October 1, 2020
Primary Completion
June 5, 2024
Study Completion
July 12, 2024
Last Updated
December 12, 2025
Results First Posted
July 8, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com