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A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
Sponsor: Novo Nordisk A/S
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.
Official title: Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
792
Start Date
2020-10-01
Completion Date
2024-07-12
Last Updated
2026-06-05
Healthy Volunteers
No
Interventions
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 (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.
Locations (283)
Cardiology, PC
Birmingham, Alabama, United States
Cardiovascular Associates of the Southeast
Birmingham, Alabama, United States
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Chandler Regional Medical Center
Chandler, Arizona, United States
Abrazo Diabetes Care Center
Glendale, Arizona, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
Cardio Innovation & Resch Ctr
Long Beach, California, United States
Angel City Research, Inc.
Los Angeles, California, United States
St. Joseph Heritage Healthcare_Mission Viejo
Mission Viejo, California, United States
Adventist Hlth St Helena Hosp
St. Helena, California, United States
Stanford University Medical Center
Stanford, California, United States
Stanford University_Stanford
Stanford, California, United States
Rocky Mount Reg VA Med-DN
Aurora, Colorado, United States
UC Health Heart & Vascular Center
Aurora, Colorado, United States
Univ of Colorado at Denver
Aurora, Colorado, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
CV Res Ctr of S Florida
Miami, Florida, United States
Cardiovascular Institute of Central Florida
Ocala, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Cardiovascular Ctr of Sarasota
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Accel Research Site-Georgia
Eatonton, Georgia, United States
Reg Infectious Dis Infuse Ctr
La Grange, Georgia, United States
Aiyan Diabetes Center
Martinez, Georgia, United States
Atlanta Heart Specialists, LLC
Tucker, Georgia, United States
Northwestern University_Chicago
Chicago, Illinois, United States
Endeavor Health Glenbook Hosp
Glenview, Illinois, United States
Central IL Diabetes and Clinical Research
Springfield, Illinois, United States
Cardiovascular Rsrch of NW_IN
Munster, Indiana, United States
Central Cardio Assoc HPS
Elizabethtown, Kentucky, United States
Cambridge Medical Trials
Alexandria, Louisiana, United States
LOUISIANA HEART Center
Covington, Louisiana, United States
Clinical Trials of Ame, LLC
Monroe, Louisiana, United States
Ascension Saint Agnes Heart Ca
Baltimore, Maryland, United States
Boston Medical Center_Boston_1
Boston, Massachusetts, United States
Boston Medical Center_Cary
Boston, Massachusetts, United States
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Minneapolis Cardiology Assoc
Minneapolis, Minnesota, United States
University of Minnesota_Minneapolis_1
Minneapolis, Minnesota, United States
Amicis Centers of Clinical Research
St Louis, Missouri, United States
Nebraska West Iowa Hlth System
Omaha, Nebraska, United States
Methodist Phys Clin Heart Cons
Omaha, Nebraska, United States
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, United States
NJ Heart
Linden, New Jersey, United States
NYU Langone Med Assoc Chelsea
New York, New York, United States
Mount Sinai Hosp at NYC
New York, New York, United States
UNC- Chapel Hill
Chapel Hill, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Accellacare_NC
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Mount Carmel Heart and Vascular
Columbus, Ohio, United States
Advanced Med Res Maumee
Maumee, Ohio, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States
Capital Area Research LLC
Camp Hill, Pennsylvania, United States
Penn Presb Med Ctr
Philadelphia, Pennsylvania, United States
Thomas Jefferson Univ Di Rsrch Ctr
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Vanderbilt U Med Ctr_Nashville
Nashville, Tennessee, United States
PharmaTex Research
Amarillo, Texas, United States
St. David's Medical Center
Austin, Texas, United States
Soltero Cardiovascular Research Center
Dallas, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
UT Southwestern
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Northwest Houston Cardiology, P.A.
Houston, Texas, United States
Houston Heart & Vascular Associates
Humble, Texas, United States
Texas Cardiology Associates of Houston
Kingwood, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
North Dallas Research Associates
McKinney, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Univ Of Texas Hlth Science Cntr
San Antonio, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
San Antonio Endovascular and Heart Institute
San Antonio, Texas, United States
Cardiovascular Associates East Texas
Tyler, Texas, United States
Victoria Heart and Vasc Ctr
Victoria, Texas, United States
Alpine Research Organization Inc
Farmington, Utah, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Carient Heart and Vascular
Manassas, Virginia, United States
Roanoke Heart Institute
Roanoke, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
Winchester Medical Center
Winchester, Virginia, United States
Aspirus Research Institute
Wausau, Wisconsin, United States
Universitätsklinik für Innere Medizin Graz
Graz, Austria
Univ.-Klinik für Innere Medizin III
Innsbruck, Austria
Klinik Landstraße
Vienna, Austria
AKH Wien
Vienna, Austria
Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery
Bonheiden, Belgium
Ziekenhuis Oost-Limburg AV - Thoracic
Genk, Belgium
UZ Gent - Thoracale Vasculaire Heelkunde
Ghent, Belgium
UZ Gent_Gent_1
Ghent, Belgium
AZ Groeninge - Thoracic Vascular Surgery
Kortrijk, Belgium
UZ Leuven - Hart en Vaatziekten
Leuven, Belgium
St Pauls Hospital
Vancouver, British Columbia, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
LMC Diabetes & Endocrinology (Barrie)
Barrie, Ontario, Canada
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, Canada
Children's Hosptial London Health Sciences Centre
London, Ontario, Canada
Intrepid Health
Mississauga, Ontario, Canada
LMC Research Inc. Ottawa
Nepean, Ontario, Canada
North York Diagn & Cardiac Ctr
North York, Ontario, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, Canada
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada
ViaCar Recherche Clinique Inc
Brossard, Quebec, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Clinique Sante Cardio MC
Montreal, Quebec, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, Quebec, Canada
CISSS des Laurentides
Saint-Jérôme, Quebec, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
G.A. Research Associates Ltd.
Moncton, Canada
CHU de Quebec-Universite Laval
Québec, Canada
Institut universitaire de cardiologie
Québec, Canada
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Jilin, China
The first hospital of Jilin University
Changchun, Jilin, China
1st Affiliated Hosp of Xi'an JiaoTong Uni Medical College
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an JiaoTong University-Cardiovascular
Xi'an, Shaanxi, China
Tianjin Union Medical Center-Cardiology
Tianjin, China
Tianjin Union Medicine Centre
Tianjin, China
Matmed s.r.o.
Hodonín, Czechia
EDUMED Jaromer
Jaroměř, Czechia
Kucera
Ostrava Dubina, Czechia
Pedicor Care s.r.o.
Ostrava Dubina, Czechia
Diabetologicka ambulance Plzen
Pilsen, Czechia
II. interni klinika - klinika kardiologie a angiologie 1. LF
Prague, Czechia
Institut klinické a experimentální medicíny
Prague, Czechia
Kolding Sygehus Karkirurgi
Kolding, Denmark
Rigshospitalet Karkirurgisk afd. RK 3111
København Ø, Denmark
Hjerte-, Lunge- og Karkirurgisk afdeling T
Odense, Denmark
Regionshospitalet Viborg - Karkirurgisk Afsnit
Viborg, Denmark
Kardiologische Praxis, Bad Homburg
Bad Homburg, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, Germany
Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden)
Dresden, Germany
Uniklinik TU Dresden - Med. Klinik und Poliklinik III Angiologie
Dresden, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, Germany
Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, Germany
Universitätsmedizin der JGU Mainz - Kardiologie I
Mainz, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, Germany
Gemeinschaftspraxis Haggenmiller/Jeserich
Nuremberg, Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, Germany
University Hospital of Athens ATTIKON
Athens, Attica, Greece
"Laiko" General Hospital of Athens
Athens, Greece
Konstantopouleio G.H. of Athens, "Agia Olga"
Athens, Greece
"Hygeia" General Hospital of Athens
Athens, Greece
General Hospital of Chios "Skilitsio" - Cardiology Clinic
Chios, Greece
General Hospital of Lamia
Lamia, Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, Greece
Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia
Szeged, Csongrád-Csanád, Hungary
Léda Platán Magánklinika
Zalaegerszeg, Zala County, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest, Hungary
Szent Imre Egyetemi Oktatókórház Angiológia
Budapest, Hungary
Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
Budapest, Hungary
Coromed SMO Kft.
Pécs, Hungary
Sanjeevani Superspeciality Hospital
Ahmedabad, Gujarat, India
Shri B D Mehta Mahavir Heart Institute
Surat, Gujarat, India
Shri B. D. Mehta Mahavir Heart Institute
Surat, Gujarat, India
Unicare heart institute and research centre
Surat, Gujarat, India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, India
Ramaiah Memorial Hospital
Bangalore, Karnataka, India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bengaluru, Karnataka, India
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, India
Shri Krishna Hrudayalaya & Critical Care Centre
Nagpur, Maharashtra, India
Shrikrishna Hrudayalaya and critical care centre
Nagpur, Maharashtra, India
Vijan Hospital & Research Centre
Nashik, Maharashtra, India
Grant Medical Foundation
Pune, Maharashtra, India
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi, National Capital Territory of Delhi, India
Batra Hospital and Medical Research Center
New Delhi, National Capital Territory of Delhi, India
VMMC & Safdarjung Hospital
New Dehli, New Delhi, India
Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, India
Dayanand Medical College & Hospital
Ludhiana, Punjab, India
SP Medical College
Bikaner, Rajasthan, India
Eternal Heart Care Centre
Jaipur, Rajasthan, India
M.V.Hospital for Diabetes Pvt. Ltd.
Chennai, Tamil Nadu, India
Osmania General Hospital
Hyderabad, Telangana, India
Udyaan Health Care
Lucknow, Uttar Pradesh, India
Gandhi Memorial Hospital- King George's Medical University
Lucknow, Uttar Pradesh, India
Care Hospital
Hyderabad, India
Sir Ganga Ram Hospital
New Delhi, India
New Tokyo Heart Clinic_Cardiology
Chiba, Japan
New Tokyo Heart Clinic_Matsudo-shi, Chiba,
Chiba, Japan
Akaicho Clinic
Chiba-shi, Chiba, Japan
Takahashi Hospital_Cardiology
Hyōgo, Japan
Higashi Takarazuka Satoh Hospital_Cardiology
Hyōgo, Japan
Higashi Takarazuka Satoh Hospital
Hyōgo, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, Japan
Naka Kinen Clinic
Ibaraki, Japan
Nishiyamado Keiwa Hospital_Internal Medicine
Ibaraki, Japan
Omihachiman Community Medical Center_Cardiovascular Medicine
Omihachiman-shi, Siga, Japan
Omihachiman Community Medical Center_Omihachiman-shi, Siga
Omihachiman-shi, Siga, Japan
Minamiosaka Hospital_Internal medicine
Osaka, Japan
Saitama Cardiovascular and Respiratory Center
Saitama, Japan
Omi Medical Center_Cardiovascular Medicine
Shiga, Japan
Omi Medical Center
Shiga, Japan
Minamino Cardiovascular Hospital_Cardiovascular medicine
Tokyo, Japan
P. Stradins Clinical University Hospital
Riga, Latvia
Stradini PAD
Riga, Latvia
Health Center-4
Riga, Latvia
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Hospital Serdang
Serdang, Selangor, Malaysia
Sunway Medical Centre
Subang Jaya, Selangor, Malaysia
University Technology MARA (UiTM) - Sg Buloh
Sungai Buloh, Selangor, Malaysia
National Heart Institute
Kuala Lumpur, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Hospital Queen Elizabeth II
Sabak Bernam, Malaysia
Haukeland universitetssykehus - Karkirurgisk avdeling
Bergen, Norway
Sørlandet sykehus HF Kristiansand
Kristiansand, Norway
OUS, Aker
Oslo, Norway
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, Poland
UniCardia & UniMedica & UniEstetica
Krakow, Poland
Clinical Best Solutions Sp. z o.o., Sp. k
Lublin, Poland
Centrum Medyczne OMEDICA
Poznan, Poland
Uniwersytetu Medycznego im.Karola Marcinkowskiego w Poznaniu
Poznan, Poland
Velocity Nova Sp. z o.o.
Puławy, Poland
Gabinety Lekarskie LabMed
Szczecin, Poland
Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego
Warsaw, Poland
DoktorA
Warsaw, Poland
Centrum Badan Klinicznych
Wroclaw, Poland
Multispecialty Medical Clinic Anturium LLC
Barnaul, Russia
Road Clinical Hospital at station Chelyabinsk
Chelyabinsk, Russia
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk, Russia
Limited Liability Company "Alliance Biomedical Ural Group"
Izhevsk, Russia
KSFMU, Inrereginal Clinical Diagnostic center
Kazan', Russia
SRMC "Your Health" LLC
Kazan', Russia
LLC Medical center "Maksimum Zdorovia"
Kemerovo, Russia
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, Russia
Federal Bureau for Medical and Social Expertise
Moscow, Russia
Pirogov Russian National Research Medical University MoH
Moscow, Russia
LLC RC Medical
Novosibirsk, Russia
SGIoH of Novosibirsk region "CC Hospital #19"
Novosibirsk, Russia
State Novosibirsk regional clinical hospital
Novosibirsk, Russia
LLC "Clinical diagnostic center Ultramed"
Omsk, Russia
Ryazan State Medical University
Ryazan, Russia
Joint Stock Company "Polyclinic Complex"
Saint Petersburg, Russia
Limited Liability Company "Clinic" MEDINEF "
Saint Petersburg, Russia
Limited Liability Company "Energiya Zdoroviya"
Saint Petersburg, Russia
St.Petersburg State Medical Academy named after Mechnikov
Saint Petersburg, Russia
SGHI "Polyclinic #106"
Saint Petersburg, Russia
Regional clinical cardiology dispensary
Saratov, Russia
SHI Saratov City Clinical Hospital #9
Saratov, Russia
Tomsk National Research Medical Center of the RAS
Tomsk, Russia
Voronezh Regional Clinical Consultive-diagnostic Centre
Voronezh, Russia
Polyclinic #2 in Yoshkar-Ola
Yoshkar-Ola, Russia
Centro Periférico de Especialidades Bola Azul
Almería, Spain
Hospital Vithas Sevilla
Castilleja de la Cuesta, Spain
Hospital Reina Sofia
Córdoba, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Civil de Málaga
Málaga, Spain
Hospital Virgen de la Macarena
Seville, Spain
Sahlgrenska US - Kärlkirurgen
Gothenburg, Sweden
Uppsala US - Kärlmottagningen
Uppsala, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Kuang Tien General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital_main
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan, Taiwan
Srinagarind Hospital
Muang, Changwat Khon Kaen, Thailand
King Chulalongkorn Memorial Hospital_Cardiology
Bangkok, Thailand
Phramongkutklao Hospital-cardio
Bangkok, Thailand
Phramongkutklao Hospital_Cardiology
Bangkok, Thailand
Research Institute for Health Sciences, CMU
Chiang Mai, Thailand
RIHES-CMU_Research Institute for Health Sciences
Chiang Mai, Thailand
Srinagarind Hospital
Khon Kaen, Thailand
Maharat Nakhon Ratchasima Hospital_Cardiology
Nakhon Ratchasima, Thailand
Maharat Nakhon Ratchasima Hospital_Ratchasima
Nakhon Ratchasima, Thailand
Thammasat University Hospital_Pathumthani
Pathum Thani, Thailand
Songklanagarind Hospital
Songkhla, Thailand