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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Peripheral Arterial Disease
• Intervention / Treatment: Drug: Semaglutide; Drug: Placebo (semaglutide)

• Study Type: Interventional
• Enrollment (Actual): 792
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Universitätsklinik für Innere Medizin Graz
  • Innsbruck, Austria, 6020
    • Univ.-Klinik für Innere Medizin III
  • Vienna, Austria, 1090
    • Akh Wien
  • Vienna, Austria, 1030
    • Klinik Landstraße
• Belgium
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg AV - Thoracic
  • Ghent, Belgium, 9000
    • UZ Gent - Thoracale Vasculaire Heelkunde
  • Ghent, Belgium, 9000
    • UZ Gent_Gent_1
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - Thoracic Vascular Surgery
  • Leuven, Belgium, 3000
    • UZ Leuven - Hart en Vaatziekten
• Canada
  • Moncton, Canada
    • G.A. Research Associates Ltd.
  • Québec, Canada, G1V 4G5
    • Institut universitaire de cardiologie
  • Québec, Canada, G1L 3L5
    • CHU de Québec-Université Laval
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St Pauls Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg Clinic
  • Ontario
    • Barrie, Ontario, Canada, L4N 7L3
      • LMC Diabetes & Endocrinology (Barrie)
    • Brampton, Ontario, Canada, L6S 0C6
      • LMC ClinRsrh Inc.Brampton
    • Cambridge, Ontario, Canada, N1R 6V6
      • Cambridge Cardiac Care Centre
    • London, Ontario, Canada, N6A 5W9
      • Children's Hosptial London Health Sciences Centre
    • Mississauga, Ontario, Canada, L5M 0N7
      • Intrepid Health
    • Nepean, Ontario, Canada, K2J 0V2
      • LMC Research Inc. Ottawa
    • North York, Ontario, Canada, M6B 3H7
      • North York Diagnostic and Cardiac Centre
    • North York, Ontario, Canada, M6B 3H7
      • North York Diagn & Cardiac Ctr
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital, Civic Campus
    • Peterborough, Ontario, Canada, K9J 0B2
      • Kawartha Cardiology Clinical Trials
  • Quebec
    • Brossard, Quebec, Canada, J4Z 2K9
      • ViaCar Recherche Clinique Inc
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Ecogene-21
    • Montreal, Quebec, Canada, H1T 3Y7
      • Clinique Sante Cardio MC
    • Montreal, Quebec, Canada, QC H1T 1C8
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H1Y 3H5
      • Recherche GCP Research
    • Québec, Quebec, Canada, G1J 1Z4
      • CHU de Québec-Université Laval
    • Saint-Jérôme, Quebec, Canada, J7Z 5T3
      • CISSS des Laurentides
    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Diex Recherche Trois-Rivieres
• China
  • Tianjin, China, 300121
    • Tianjin Union Medicine Centre
  • Tianjin, China, 300121
    • Tianjin Union Medical Center-Cardiology
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Xuanwu Hospital Capital Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050051
      • Hebei General Hospital
  • Jilin
    • Changchun, Jilin, China, 130061
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130061
      • The First Bethune hospital of Jilin University-Endocrinology
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • 1st Affiliated Hosp of Xi'an JiaoTong Uni Medical College
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an JiaoTong University-Cardiovascular
• Czechia
  • Hodonín, Czechia, 695 01
    • Matmed s.r.o.
  • Jaroměř, Czechia, 55101
    • EDUMED Jaromer
  • Ostrava Dubina, Czechia, 700 30
    • Kucera
  • Ostrava Dubina, Czechia, 700 30
    • Pedicor Care s.r.o.
  • Pilsen, Czechia, 301 00
    • Diabetologicka ambulance Plzen
  • Prague, Czechia, 140 21
    • Institut klinické a experimentální medicíny
  • Prague, Czechia, 128 08
    • II. interni klinika - klinika kardiologie a angiologie 1. LF
• Denmark
  • Kolding, Denmark, 6000
    • Kolding Sygehus Karkirurgi
  • København Ø, Denmark, 2100
    • Rigshospitalet Karkirurgisk afd. RK 3111
  • Odense, Denmark, 5000
    • Hjerte-, Lunge- og Karkirurgisk afdeling T
  • Viborg, Denmark, 8800
    • Regionshospitalet Viborg - Karkirurgisk Afsnit
• Germany
  • Bad Homburg, Germany, 61348
    • Kardiologische Praxis, Bad Homburg
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
  • Dresden, Germany, 01277
    • Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden)
  • Dresden, Germany, 01307
    • Uniklinik TU Dresden - Med. Klinik und Poliklinik III Angiologie
  • Frankfurt, Germany, 60389
    • MVZ CCB Frankfurt und Main-Taunus GbR
  • Lübeck, Germany, 23538
    • Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
  • Mainz, Germany, 55131
    • Universitätsmedizin der JGU Mainz - Kardiologie I
  • Münster, Germany, 48145
    • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  • Nuremberg, Germany, 90402
    • Gemeinschaftspraxis Haggenmiller/Jeserich
  • Saint Ingbert-Oberwürzbach, Germany, 66386
    • Zentrum für klinische Studien Alexander Segner
• Greece
  • Athens, Greece, 11527
    • "Laiko" General Hospital of Athens
  • Athens, Greece, 14233
    • Konstantopouleio G.H. of Athens, "Agia Olga"
  • Athens, Greece, 15123
    • "Hygeia" General Hospital of Athens
  • Chios, Greece, 82100
    • General Hospital of Chios "Skilitsio" - Cardiology Clinic
  • Lamia, Greece, 35100
    • General Hospital of Lamia
  • Thessaloniki, Greece, 54642
    • 'Ippokrateio' General Hospital of Thessaloniki
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki "G.Papanikolaou"
  • Attica
    • Athens, Attica, Greece, 12462
      • University Hospital of Athens ATTIKON
• Hungary
  • Budapest, Hungary, 1032
    • Szent Margit Rendelőintézet Nonprofit Kft.
  • Budapest, Hungary, 1115
    • Szent Imre Egyetemi Oktatókórház Angiológia
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
  • Pécs, Hungary, 7623
    • Coromed SMO Kft.
  • Csongrád-Csanád
    • Szeged, Csongrád-Csanád, Hungary, 6725
      • Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia
  • Zala County
    • Zalaegerszeg, Zala County, Hungary, 8900
      • Léda Platán Magánklinika
• India
  • Hyderabad, India, 600034
    • Care Hospital
  • New Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • Sanjeevani Superspeciality Hospital
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Pvt. Ltd.
    • Surat, Gujarat, India, 395001
      • Shri B D Mehta Mahavir Heart Institute
    • Surat, Gujarat, India, 395001
      • Shri B. D. Mehta Mahavir Heart Institute
    • Surat, Gujarat, India, 395001
      • Unicare heart institute and research centre
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • Ramaiah Memorial Hospital
    • Bengaluru, Karnataka, India, 560069
      • Sri Jayadeva Institute of Cardiovascular Sciences & Research
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Seth GS medical college and KEM Hospital
    • Nagpur, Maharashtra, India, 440012
      • Shri Krishna Hrudayalaya & Critical Care Centre
    • Nagpur, Maharashtra, India, 440012
      • Shrikrishna Hrudayalaya and critical care centre
    • Nashik, Maharashtra, India, 422005
      • Vijan Hospital & Research Centre
    • Pune, Maharashtra, India, 411001
      • Grant Medical Foundation
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110002
      • G B Pant Institute of Postgraduate Medical Education and Research
    • New Delhi, National Capital Territory of Delhi, India, 110062
      • Batra Hospital and Medical Research Center
  • New Delhi
    • New Dehli, New Delhi, India, 110029
      • VMMC & Safdarjung Hospital
  • Punjab
    • Chandigarh, Punjab, India, 160012
      • Post Graduate Institute of Medical Education & Research
    • Ludhiana, Punjab, India, 141001
      • Dayanand Medical College & Hospital
  • Rajasthan
    • Bikaner, Rajasthan, India, 334003
      • SP Medical College
    • Jaipur, Rajasthan, India, 302017
      • Eternal Heart Care Centre
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 013
      • M.V.Hospital for Diabetes Pvt. Ltd.
  • Telangana
    • Hyderabad, Telangana, India, 500012
      • Osmania General Hospital
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226002
      • Udyaan Health Care
    • Lucknow, Uttar Pradesh, India, 226003
      • Gandhi Memorial Hospital- King George's Medical University
• Japan
  • Chiba, Japan, 271-0077
    • New Tokyo Heart Clinic_Matsudo-shi, Chiba,
  • Chiba, Japan, 271-0077
    • New Tokyo Heart Clinic_Cardiology
  • Chiba-shi, Chiba, Japan, 260-0804
    • Akaicho Clinic
  • Hyōgo, Japan, 654-0026
    • Takahashi Hospital_Cardiology
  • Hyōgo, Japan, 665-0873
    • Higashi Takarazuka Satoh Hospital_Cardiology
  • Hyōgo, Japan, 665-0873
    • Higashi Takarazuka Satoh Hospital
  • Ibaraki, Japan, 311-0113
    • Naka Kinen Clinic
  • Ibaraki, Japan, 311-0113
    • Naka Kinen Clinic_Internal medicine
  • Ibaraki, Japan, 331-0133
    • Nishiyamado Keiwa Hospital_Internal Medicine
  • Omihachiman-shi, Siga, Japan, 523-0082
    • Omihachiman Community Medical Center_Omihachiman-shi, Siga
  • Omihachiman-shi, Siga, Japan, 523-0082
    • Omihachiman Community Medical Center_Cardiovascular Medicine
  • Osaka, Japan, 559-0012
    • Minamiosaka Hospital_Internal medicine
  • Saitama, Japan, 360-0197
    • Saitama Cardiovascular and Respiratory Center
  • Shiga, Japan, 525-8585
    • Omi Medical Center
  • Shiga, Japan, 525-8585
    • Omi Medical Center_Cardiovascular Medicine
  • Tokyo, Japan, 192-0918
    • Minamino Cardiovascular Hospital_Cardiovascular medicine
• Latvia
  • Riga, Latvia, 1002
    • P. Stradins Clinical University Hospital
  • Riga, Latvia, LV-1002
    • Stradini PAD
  • Riga, Latvia, LV1012
    • Health Center-4
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia, 50400
    • National Heart Institute
  • Sabak Bernam, Malaysia, 88300
    • Hospital Queen Elizabeth II
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Hospital Universiti Sains Malaysia
  • Kuala Lumpur
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Hospital Tengku Ampuan Afzan
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10990
      • Hospital Pulau Pinang
  • Selangor
    • Serdang, Selangor, Malaysia, 43000
      • Hospital Serdang
    • Subang Jaya, Selangor, Malaysia, 47500
      • Sunway Medical Centre
    • Sungai Buloh, Selangor, Malaysia, 47000
      • University Technology MARA (UiTM) - Sg Buloh
• Norway
  • Bergen, Norway, 5021
    • Haukeland universitetssykehus - Karkirurgisk avdeling
  • Kristiansand, Norway, 4615
    • Sørlandet sykehus HF Kristiansand
  • Oslo, Norway, 0586
    • OUS, Aker
• Poland
  • Krakow, Poland, 31-271
    • UniCardia & UniMedica & UniEstetica
  • Lublin, Poland, 20-078
    • Clinical Best Solutions Sp. z o.o., Sp. k
  • Poznan, Poland, 60-111
    • Centrum Medyczne OMEDICA
  • Poznan, Poland, 61-848
    • Uniwersytetu Medycznego im.Karola Marcinkowskiego w Poznaniu
  • Puławy, Poland, 24-100
    • Velocity Nova Sp. z o.o.
  • Szczecin, Poland, 71-531
    • Gabinety Lekarskie LabMed
  • Warsaw, Poland, 04-628
    • Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego
  • Warsaw, Poland, 05-077
    • DoktorA
  • Wroclaw, Poland, 51-162
    • Centrum Badan Klinicznych
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-261
      • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
• Russia
  • Barnaul, Russia, 656043
    • Multispecialty Medical Clinic Anturium LLC
  • Chelyabinsk, Russia, 454048
    • Road Clinical Hospital at station Chelyabinsk
  • Irkutsk, Russia, 664049
    • Irkutsk State Medical Academy of Postgraduate Education
  • Izhevsk, Russia, 426061
    • Limited Liability Company "Alliance Biomedical Ural Group"
  • Kazan', Russia, 420010
    • KSFMU, Inrereginal Clinical Diagnostic center
  • Kazan', Russia, 420097
    • SRMC "Your Health" LLC
  • Kemerovo, Russia, 650066
    • LLC Medical center "Maksimum Zdorovia"
  • Moscow, Russia, 117292
    • FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
  • Moscow, Russia, 129226
    • Pirogov Russian National Research Medical University MoH
  • Moscow, Russia, 127486
    • Federal Bureau for Medical and Social Expertise
  • Novosibirsk, Russia, 630087
    • State Novosibirsk regional clinical hospital
  • Novosibirsk, Russia, 630005
    • LLC RC Medical
  • Novosibirsk, Russia, 630068
    • SGIoH of Novosibirsk region "CC Hospital #19"
  • Omsk, Russia, 644024
    • LLC "Clinical diagnostic center Ultramed"
  • Ryazan, Russia, 390026
    • Ryazan State Medical University
  • Saint Petersburg, Russia, 190013
    • Joint Stock Company "Polyclinic Complex"
  • Saint Petersburg, Russia, 194156
    • Limited Liability Company "Energiya Zdoroviya"
  • Saint Petersburg, Russia, 194044
    • Limited Liability Company "Clinic" MEDINEF "
  • Saint Petersburg, Russia, 198328
    • SGHI "Polyclinic #106"
  • Saint Petersburg, Russia, 195067
    • St.Petersburg State Medical Academy named after Mechnikov
  • Saratov, Russia, 410031
    • SHI Saratov City Clinical Hospital #9
  • Saratov, Russia, 410028
    • Regional clinical cardiology dispensary
  • Tomsk, Russia, 634012
    • Tomsk National Research Medical Center of the RAS
  • Voronezh, Russia, 394018
    • Voronezh Regional Clinical Consultive-diagnostic Centre
  • Yoshkar-Ola, Russia, 424004
    • Polyclinic #2 in Yoshkar-Ola
• Spain
  • Almería, Spain, 04009
    • Centro Periférico de Especialidades Bola Azul
  • Castilleja de la Cuesta, Spain, 41950
    • Hospital Vithas Sevilla
  • Córdoba, Spain, 14004
    • Hospital Reina Sofia
  • Madrid, Spain, 28009
    • Hospital Gregorio Marañón
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Málaga, Spain, 29009
    • Hospital Civil de Málaga
  • Seville, Spain, 41009
    • Hospital Virgen de la Macarena
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska US - Kärlkirurgen
  • Uppsala, Sweden, 751 85
    • Uppsala US - Kärlmottagningen
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 433
    • Kuang Tien General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital_main
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou Branch
• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital-cardio
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital_Cardiology
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital_Cardiology
  • Chiang Mai, Thailand, 50200
    • Research Institute for Health Sciences, CMU
  • Chiang Mai, Thailand, 50200
    • RIHES-CMU_Research Institute for Health Sciences
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Nakhon Ratchasima, Thailand, 30000
    • Maharat Nakhon Ratchasima Hospital_Ratchasima
  • Nakhon Ratchasima, Thailand, 30000
    • Maharat Nakhon Ratchasima Hospital_Cardiology
  • Pathum Thani, Thailand, 12120
    • Thammasat University Hospital_Pathumthani
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital
  • Changwat Khon Kaen
    • Muang, Changwat Khon Kaen, Thailand, 40002
      • Srinagarind Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Cardiovascular Associates of the Southeast
    • Birmingham, Alabama, United States, 35211
      • Cardiology, PC
    • Birmingham, Alabama, United States, 35294
      • Univ of Alabama Birmingham
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Regional Medical Center
    • Glendale, Arizona, United States, 85308
      • Abrazo Diabetes Care Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Veteran's Healthcare System
  • California
    • Long Beach, California, United States, 90813
      • Cardio Innovation & Resch Ctr
    • Los Angeles, California, United States, 90010
      • Angel City Research, Inc.
    • Mission Viejo, California, United States, 92691
      • St. Joseph Heritage Healthcare_Mission Viejo
    • St. Helena, California, United States, 94574
      • Adventist Hlth St Helena Hosp
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
    • Stanford, California, United States, 94305
      • Stanford University_Stanford
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mount Reg VA Med-DN
    • Aurora, Colorado, United States, 80045
      • Univ of Colorado at Denver
    • Aurora, Colorado, United States, 80045
      • UC Health Heart & Vascular Center
  • Florida
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology Associates, P.A.
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Consultants
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Ctr For Clin Res
    • Miami, Florida, United States, 33173
      • CV Res Ctr of S Florida
    • Ocala, Florida, United States, 34471
      • Cardiovascular Institute of Central Florida
    • Pinellas Park, Florida, United States, 33782
      • DMI Research
    • Sarasota, Florida, United States, 34239
      • Cardiovascular Ctr of Sarasota
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Eatonton, Georgia, United States, 31024
      • Accel Research Site-Georgia
    • La Grange, Georgia, United States, 30240
      • Reg Infectious Dis Infuse Ctr
    • Martinez, Georgia, United States, 30907
      • Aiyan Diabetes Center
    • Tucker, Georgia, United States, 30084
      • Atlanta Heart Specialists, LLC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University_Chicago
    • Glenview, Illinois, United States, 60026
      • Endeavor Health Glenbook Hosp
    • Springfield, Illinois, United States, 62701
      • Central IL Diabetes and Clinical Research
  • Indiana
    • Munster, Indiana, United States, 46321
      • Cardiovascular Rsrch of NW_IN
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Central Cardio Assoc HPS
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Cambridge Medical Trials
    • Covington, Louisiana, United States, 70433
      • LOUISIANA HEART Center
    • Monroe, Louisiana, United States, 71201
      • Clinical Trials of Ame, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Ascension Saint Agnes Heart Ca
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Steward St. Elizabeth's Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center_Cary
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center_Boston_1
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota_Minneapolis_1
    • Minneapolis, Minnesota, United States, 55407-1195
      • Minneapolis Cardiology Assoc
  • Missouri
    • St Louis, Missouri, United States, 63128
      • Amicis Centers of Clinical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Nebraska West Iowa Hlth System
    • Omaha, Nebraska, United States, 68114
      • Methodist Phys Clin Heart Cons
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Med Ctr
  • New Jersey
    • Linden, New Jersey, United States, 07036
      • NJ Heart
  • New York
    • New York, New York, United States, 10001
      • NYU Langone Med Assoc Chelsea
    • New York, New York, United States, 10029
      • Mount Sinai Hosp at NYC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC- Chapel Hill
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research
    • Wilmington, North Carolina, United States, 28401
      • Accellacare_NC
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research LLC
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43213
      • Mount Carmel Heart and Vascular
    • Maumee, Ohio, United States, 43537
      • Advanced Med Res Maumee
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • South Oklahoma Heart Research, LLC
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research LLC
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presb Med Ctr
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Univ Di Rsrch Ctr
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt U Med Ctr_Nashville
  • Texas
    • Amarillo, Texas, United States, 79106
      • PharmaTex Research
    • Austin, Texas, United States, 78705
      • St. David's Medical Center
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Dallas, Texas, United States, 75226
      • Soltero Cardiovascular Research Center
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Res-Dallas
    • Dallas, Texas, United States, 75390-9302
      • UT Southwestern Med Cntr
    • Houston, Texas, United States, 77030-2703
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77070
      • Northwest Houston Cardiology, P.A.
    • Humble, Texas, United States, 77338
      • Houston Heart & Vascular Associates
    • Kingwood, Texas, United States, 77339
      • Texas Cardiology Associates of Houston
    • Lubbock, Texas, United States, 79430-8183
      • Texas Tech University Health Science Center
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio
    • San Antonio, Texas, United States, 78258
      • San Antonio Endovascular and Heart Institute
    • San Antonio, Texas, United States, 78229
      • Univ Of Texas Hlth Science Cntr
    • Tyler, Texas, United States, 75701
      • Cardiovascular Associates East Texas
    • Victoria, Texas, United States, 77901
      • Victoria Heart and Vasc Ctr
  • Utah
    • Farmington, Utah, United States, 84025
      • Alpine Research Organization Inc
  • Virginia
    • Falls Church, Virginia, United States, 22042-3300
      • Inova Heart and Vascular Institute
    • Manassas, Virginia, United States, 20109
      • Carient Heart and Vascular
    • Roanoke, Virginia, United States, 24014
      • Roanoke Heart Institute
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center
    • Winchester, Virginia, United States, 22601-3834
      • Selma Medical Associates
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. 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.
  2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.
  3. 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.
  4. 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide; Semaglutide given in addition to standard-of-care treatment	Drug: Semaglutide; 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 Comparator: Placebo (semaglutide); Placebo given in addition to standard-of-care treatment	Drug: Placebo (semaglutide); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up 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, which-ever 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 follow-up (week 57)
Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score	Change in VascuQoL-6 score is presented. VascuQoL-6 is a peripheral artery disease-specific questionnaire with 6 items covering social, emotional, functional as well as pain- and symptom-related aspects of the patient´s overall quality of life. Each item has a 4-point response scale (where 1 = worst score and 4 = best score). The endpoint analysed is the total score (range: 6-24) generated by summing the scores from all items. A higher score indicates better health status. 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)
Change in Pain-free Walking Distance on a Constant Load Treadmill Test	Change in pain-free 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 are instructed to when pain starts in either leg and to continue on the treadmill without stopping at this stage. The distance walked is noted as the pain-free 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)
Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test	Change in pain-free 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 are instructed to when pain starts in either leg and to continue on the treadmill without stop-ping at this stage. The distance walked is noted as the pain-free 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 follow-up (week 57)
Change in Glycosylated Haemoglobin (HbA1c)	Change in HbA1c from baseline to week 52 in percentage-point is presented. The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)
Change in Body Weight	Change in body weight from baseline to week 52 in kilogram (kg) is presented. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)
Change in Systolic Blood Pressure	Change in systolic blood pressure from baseline to week 52 is presented.The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)
Change in Total Cholesterol	Change in total cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)
Change in Low-density Lipoprotein (LDL)-Cholesterol	Change in LDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)
Change in High Density Lipoprotein (HDL)-Cholesterol	Change in HDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)
Change in Triglycerides	Change in Triglycerides from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)
Change in Ankle-Brachial Index (ABI)	Change in ABI from baseline to week 52 is presented. ABI is calculated as a ratio of the higher ankle systolic pressure to the higher systolic pressure measured in both arms. ABI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. An ABI between 1.0 to 1.4 is considered the normal range. An ABI between 0.90 to 0.99 is considered borderline. An ABI less than 0.90 indicates peripheral artery disease (PAD). The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Screening (week -2), end of treatment (week 52)
Change in Toe-Brachial Index (TBI)	Change in TBI from baseline to week 52 is presented. TBI is calculated as a ratio of the toe systolic pressure to the higher systolic pressure measured in both arms. TBI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. A TBI range of above or equal to 0.7 is considered normal, whereas a TBI less than 0.7 is considered abnormal. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Screening (week -2), end of treatment (week 52)
Change in Walking Impairment Questionnaire (WIQ) Global Score	Change in WIQ global score from baseline to week 52 is presented. WIQ consists of three domains, speed, distance, and stair climbing, consisting of in total 14 questions. Each response is weighted based on the difficulty of the task. Domain scores are determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. Global score is calculated as the mean of the three domain scores (ranged from 0% to 100%). A global score of 0% represents inabil-ity to perform any of the tasks and 100% represents no difficulty with any of the tasks. Higher scores indicate better walking ability and less impairment. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)
Change in Short Form 36 (SF-36) Physical Functioning Domain	Change in SF-36 physical functioning domain from baseline to week 52 is presented. SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2 (acute version) questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores (Range: 19.03 to 57.60) to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A positive change score indicates an improvement in participant health stats. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).	Baseline (week 0), end of treatment (week 52)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (1452), Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Peripheral Arterial Disease; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: NN9535-4533; 2019-003399-38 (Registry Identifier: European Medicines Agency (EudraCT)); U1111-1238-7071 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No