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COMPLETED
NCT04560998
PHASE3

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

View on ClinicalTrials.gov

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

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.

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.

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