NCT04560998

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

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
792

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2020

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
21 countries

283 active sites

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 8, 2025

Completed
Last Updated

June 5, 2026

Status Verified

May 1, 2026

Enrollment Period

3.7 years

First QC Date

September 18, 2020

Results QC Date

June 3, 2025

Last Update Submit

May 18, 2026

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

EXPERIMENTAL

Semaglutide given in addition to standard-of-care treatment

Drug: Semaglutide

Placebo (semaglutide)

PLACEBO COMPARATOR

Placebo given in addition to standard-of-care treatment

Drug: Placebo (semaglutide)

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.

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.

Placebo (semaglutide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (283)

Cardiology, PC

Birmingham, Alabama, 35211, United States

Location

Cardiovascular Associates of the Southeast

Birmingham, Alabama, 35243, United States

Location

Univ of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

Abrazo Diabetes Care Center

Glendale, Arizona, 85308, United States

Location

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Cardio Innovation & Resch Ctr

Long Beach, California, 90813, United States

Location

Angel City Research, Inc.

Los Angeles, California, 90010, United States

Location

St. Joseph Heritage Healthcare_Mission Viejo

Mission Viejo, California, 92691, United States

Location

Adventist Hlth St Helena Hosp

St. Helena, California, 94574, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Stanford University_Stanford

Stanford, California, 94305, United States

Location

Rocky Mount Reg VA Med-DN

Aurora, Colorado, 80045, United States

Location

UC Health Heart & Vascular Center

Aurora, Colorado, 80045, United States

Location

Univ of Colorado at Denver

Aurora, Colorado, 80045, United States

Location

Bay Area Cardiology Associates, P.A.

Brandon, Florida, 33511, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Jacksonville Ctr For Clin Res

Jacksonville, Florida, 32216, United States

Location

CV Res Ctr of S Florida

Miami, Florida, 33173, United States

Location

Cardiovascular Institute of Central Florida

Ocala, Florida, 34471, United States

Location

DMI Research

Pinellas Park, Florida, 33782, United States

Location

Cardiovascular Ctr of Sarasota

Sarasota, Florida, 34239, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Accel Research Site-Georgia

Eatonton, Georgia, 31024, United States

Location

Reg Infectious Dis Infuse Ctr

La Grange, Georgia, 30240, United States

Location

Aiyan Diabetes Center

Martinez, Georgia, 30907, United States

Location

Atlanta Heart Specialists, LLC

Tucker, Georgia, 30084, United States

Location

Northwestern University_Chicago

Chicago, Illinois, 60611, United States

Location

Endeavor Health Glenbook Hosp

Glenview, Illinois, 60026, United States

Location

Central IL Diabetes and Clinical Research

Springfield, Illinois, 62701, United States

Location

Cardiovascular Rsrch of NW_IN

Munster, Indiana, 46321, United States

Location

Central Cardio Assoc HPS

Elizabethtown, Kentucky, 42701, United States

Location

Cambridge Medical Trials

Alexandria, Louisiana, 71301, United States

Location

LOUISIANA HEART Center

Covington, Louisiana, 70433, United States

Location

Clinical Trials of Ame, LLC

Monroe, Louisiana, 71201, United States

Location

Ascension Saint Agnes Heart Ca

Baltimore, Maryland, 21229, United States

Location

Boston Medical Center_Boston_1

Boston, Massachusetts, 02118, United States

Location

Boston Medical Center_Cary

Boston, Massachusetts, 02118, United States

Location

Steward St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Minneapolis Cardiology Assoc

Minneapolis, Minnesota, 55407-1195, United States

Location

University of Minnesota_Minneapolis_1

Minneapolis, Minnesota, 55455, United States

Location

Amicis Centers of Clinical Research

St Louis, Missouri, 63128, United States

Location

Nebraska West Iowa Hlth System

Omaha, Nebraska, 68105, United States

Location

Methodist Phys Clin Heart Cons

Omaha, Nebraska, 68114, United States

Location

Dartmouth-Hitchcock Med Ctr

Lebanon, New Hampshire, 03766, United States

Location

NJ Heart

Linden, New Jersey, 07036, United States

Location

NYU Langone Med Assoc Chelsea

New York, New York, 10001, United States

Location

Mount Sinai Hosp at NYC

New York, New York, 10029, United States

Location

UNC- Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Accellacare_NC

Wilmington, North Carolina, 28401, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Mount Carmel Heart and Vascular

Columbus, Ohio, 43213, United States

Location

Advanced Med Res Maumee

Maumee, Ohio, 43537, United States

Location

South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, 73135, United States

Location

Capital Area Research LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Penn Presb Med Ctr

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson Univ Di Rsrch Ctr

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Vanderbilt U Med Ctr_Nashville

Nashville, Tennessee, 37232, United States

Location

PharmaTex Research

Amarillo, Texas, 79106, United States

Location

St. David's Medical Center

Austin, Texas, 78705, United States

Location

Soltero Cardiovascular Research Center

Dallas, Texas, 75226, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030-2703, United States

Location

Northwest Houston Cardiology, P.A.

Houston, Texas, 77070, United States

Location

Houston Heart & Vascular Associates

Humble, Texas, 77338, United States

Location

Texas Cardiology Associates of Houston

Kingwood, Texas, 77339, United States

Location

Texas Tech University Health Science Center

Lubbock, Texas, 79430-8183, United States

Location

North Dallas Research Associates

McKinney, Texas, 75069, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Univ Of Texas Hlth Science Cntr

San Antonio, Texas, 78229, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

San Antonio Endovascular and Heart Institute

San Antonio, Texas, 78258, United States

Location

Cardiovascular Associates East Texas

Tyler, Texas, 75701, United States

Location

Victoria Heart and Vasc Ctr

Victoria, Texas, 77901, United States

Location

Alpine Research Organization Inc

Farmington, Utah, 84025, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042-3300, United States

Location

Carient Heart and Vascular

Manassas, Virginia, 20109, United States

Location

Roanoke Heart Institute

Roanoke, Virginia, 24014, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Aspirus Research Institute

Wausau, Wisconsin, 54401, United States

Location

Universitätsklinik für Innere Medizin Graz

Graz, 8036, Austria

Location

Univ.-Klinik für Innere Medizin III

Innsbruck, 6020, Austria

Location

Klinik Landstraße

Vienna, 1030, Austria

Location

AKH Wien

Vienna, 1090, Austria

Location

Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery

Bonheiden, 2820, Belgium

Location

Ziekenhuis Oost-Limburg AV - Thoracic

Genk, 3600, Belgium

Location

UZ Gent - Thoracale Vasculaire Heelkunde

Ghent, 9000, Belgium

Location

UZ Gent_Gent_1

Ghent, 9000, Belgium

Location

AZ Groeninge - Thoracic Vascular Surgery

Kortrijk, 8500, Belgium

Location

UZ Leuven - Hart en Vaatziekten

Leuven, 3000, Belgium

Location

St Pauls Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

LMC Diabetes & Endocrinology (Barrie)

Barrie, Ontario, L4N 7L3, Canada

Location

LMC ClinRsrh Inc.Brampton

Brampton, Ontario, L6S 0C6, Canada

Location

Cambridge Cardiac Care Centre

Cambridge, Ontario, N1R 6V6, Canada

Location

Children's Hosptial London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Intrepid Health

Mississauga, Ontario, L5M 0N7, Canada

Location

LMC Research Inc. Ottawa

Nepean, Ontario, K2J 0V2, Canada

Location

North York Diagn & Cardiac Ctr

North York, Ontario, M6B 3H7, Canada

Location

North York Diagnostic and Cardiac Centre

North York, Ontario, M6B 3H7, Canada

Location

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Kawartha Cardiology Clinical Trials

Peterborough, Ontario, K9J 0B2, Canada

Location

ViaCar Recherche Clinique Inc

Brossard, Quebec, J4Z 2K9, Canada

Location

Ecogene-21

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Clinique Sante Cardio MC

Montreal, Quebec, H1T 3Y7, Canada

Location

Recherche GCP Research

Montreal, Quebec, H1Y 3H5, Canada

Location

Montreal Heart Institute

Montreal, Quebec, QC H1T 1C8, Canada

Location

CHU de Quebec-Universite Laval

Québec, Quebec, G1J 1Z4, Canada

Location

CISSS des Laurentides

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

G.A. Research Associates Ltd.

Moncton, Canada

Location

CHU de Quebec-Universite Laval

Québec, G1L 3L5, Canada

Location

Institut universitaire de cardiologie

Québec, G1V 4G5, Canada

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, 050051, China

Location

The First Bethune hospital of Jilin University-Endocrinology

Changchun, Jilin, 130061, China

Location

The first hospital of Jilin University

Changchun, Jilin, 130061, China

Location

1st Affiliated Hosp of Xi'an JiaoTong Uni Medical College

Xi'an, Shaanxi, 710061, China

Location

The First Affiliated Hospital of Xi'an JiaoTong University-Cardiovascular

Xi'an, Shaanxi, 710061, China

Location

Tianjin Union Medical Center-Cardiology

Tianjin, 300121, China

Location

Tianjin Union Medicine Centre

Tianjin, 300121, China

Location

Matmed s.r.o.

Hodonín, 695 01, Czechia

Location

EDUMED Jaromer

Jaroměř, 55101, Czechia

Location

Kucera

Ostrava Dubina, 700 30, Czechia

Location

Pedicor Care s.r.o.

Ostrava Dubina, 700 30, Czechia

Location

Diabetologicka ambulance Plzen

Pilsen, 301 00, Czechia

Location

II. interni klinika - klinika kardiologie a angiologie 1. LF

Prague, 128 08, Czechia

Location

Institut klinické a experimentální medicíny

Prague, 140 21, Czechia

Location

Kolding Sygehus Karkirurgi

Kolding, 6000, Denmark

Location

Rigshospitalet Karkirurgisk afd. RK 3111

København Ø, 2100, Denmark

Location

Hjerte-, Lunge- og Karkirurgisk afdeling T

Odense, 5000, Denmark

Location

Regionshospitalet Viborg - Karkirurgisk Afsnit

Viborg, 8800, Denmark

Location

Kardiologische Praxis, Bad Homburg

Bad Homburg, 61348, Germany

Location

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden)

Dresden, 01277, Germany

Location

Uniklinik TU Dresden - Med. Klinik und Poliklinik III Angiologie

Dresden, 01307, Germany

Location

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt, 60389, Germany

Location

Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck

Lübeck, 23538, Germany

Location

Universitätsmedizin der JGU Mainz - Kardiologie I

Mainz, 55131, Germany

Location

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145, Germany

Location

Gemeinschaftspraxis Haggenmiller/Jeserich

Nuremberg, 90402, Germany

Location

Zentrum für klinische Studien Alexander Segner

Saint Ingbert-Oberwürzbach, 66386, Germany

Location

University Hospital of Athens ATTIKON

Athens, Attica, 12462, Greece

Location

"Laiko" General Hospital of Athens

Athens, 11527, Greece

Location

Konstantopouleio G.H. of Athens, "Agia Olga"

Athens, 14233, Greece

Location

"Hygeia" General Hospital of Athens

Athens, 15123, Greece

Location

General Hospital of Chios "Skilitsio" - Cardiology Clinic

Chios, 82100, Greece

Location

General Hospital of Lamia

Lamia, 35100, Greece

Location

'Ippokrateio' General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

General Hospital of Thessaloniki "G.Papanikolaou"

Thessaloniki, 57010, Greece

Location

Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia

Szeged, Csongrád-Csanád, 6725, Hungary

Location

Léda Platán Magánklinika

Zalaegerszeg, Zala County, 8900, Hungary

Location

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, 1032, Hungary

Location

Szent Imre Egyetemi Oktatókórház Angiológia

Budapest, 1115, Hungary

Location

Semmelweis Egyetem Városmajori Szív- és Érgyógyászat

Budapest, 1122, Hungary

Location

Coromed SMO Kft.

Pécs, 7623, Hungary

Location

Sanjeevani Superspeciality Hospital

Ahmedabad, Gujarat, 380015, India

Location

Shri B D Mehta Mahavir Heart Institute

Surat, Gujarat, 395001, India

Location

Shri B. D. Mehta Mahavir Heart Institute

Surat, Gujarat, 395001, India

Location

Unicare heart institute and research centre

Surat, Gujarat, 395001, India

Location

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, 395002, India

Location

Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

Sri Jayadeva Institute of Cardiovascular Sciences & Research

Bengaluru, Karnataka, 560069, India

Location

Seth GS medical college and KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Shri Krishna Hrudayalaya & Critical Care Centre

Nagpur, Maharashtra, 440012, India

Location

Shrikrishna Hrudayalaya and critical care centre

Nagpur, Maharashtra, 440012, India

Location

Vijan Hospital & Research Centre

Nashik, Maharashtra, 422005, India

Location

Grant Medical Foundation

Pune, Maharashtra, 411001, India

Location

G B Pant Institute of Postgraduate Medical Education and Research

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Batra Hospital and Medical Research Center

New Delhi, National Capital Territory of Delhi, 110062, India

Location

VMMC & Safdarjung Hospital

New Dehli, New Delhi, 110029, India

Location

Post Graduate Institute of Medical Education & Research

Chandigarh, Punjab, 160012, India

Location

Dayanand Medical College & Hospital

Ludhiana, Punjab, 141001, India

Location

SP Medical College

Bikaner, Rajasthan, 334003, India

Location

Eternal Heart Care Centre

Jaipur, Rajasthan, 302017, India

Location

M.V.Hospital for Diabetes Pvt. Ltd.

Chennai, Tamil Nadu, 600 013, India

Location

Osmania General Hospital

Hyderabad, Telangana, 500012, India

Location

Udyaan Health Care

Lucknow, Uttar Pradesh, 226002, India

Location

Gandhi Memorial Hospital- King George's Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Care Hospital

Hyderabad, 600034, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

New Tokyo Heart Clinic_Cardiology

Chiba, 271-0077, Japan

Location

New Tokyo Heart Clinic_Matsudo-shi, Chiba,

Chiba, 271-0077, Japan

Location

Akaicho Clinic

Chiba-shi, Chiba, 260-0804, Japan

Location

Takahashi Hospital_Cardiology

Hyōgo, 654-0026, Japan

Location

Higashi Takarazuka Satoh Hospital_Cardiology

Hyōgo, 665-0873, Japan

Location

Higashi Takarazuka Satoh Hospital

Hyōgo, 665-0873, Japan

Location

Naka Kinen Clinic_Internal medicine

Ibaraki, 311-0113, Japan

Location

Naka Kinen Clinic

Ibaraki, 311-0113, Japan

Location

Nishiyamado Keiwa Hospital_Internal Medicine

Ibaraki, 331-0133, Japan

Location

Omihachiman Community Medical Center_Cardiovascular Medicine

Omihachiman-shi, Siga, 523-0082, Japan

Location

Omihachiman Community Medical Center_Omihachiman-shi, Siga

Omihachiman-shi, Siga, 523-0082, Japan

Location

Minamiosaka Hospital_Internal medicine

Osaka, 559-0012, Japan

Location

Saitama Cardiovascular and Respiratory Center

Saitama, 360-0197, Japan

Location

Omi Medical Center_Cardiovascular Medicine

Shiga, 525-8585, Japan

Location

Omi Medical Center

Shiga, 525-8585, Japan

Location

Minamino Cardiovascular Hospital_Cardiovascular medicine

Tokyo, 192-0918, Japan

Location

P. Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Stradini PAD

Riga, LV-1002, Latvia

Location

Health Center-4

Riga, LV1012, Latvia

Location

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Pulau Pinang

George Town, Pulau Pinang, 10990, Malaysia

Location

Hospital Serdang

Serdang, Selangor, 43000, Malaysia

Location

Sunway Medical Centre

Subang Jaya, Selangor, 47500, Malaysia

Location

University Technology MARA (UiTM) - Sg Buloh

Sungai Buloh, Selangor, 47000, Malaysia

Location

National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Hospital Queen Elizabeth II

Sabak Bernam, 88300, Malaysia

Location

Haukeland universitetssykehus - Karkirurgisk avdeling

Bergen, 5021, Norway

Location

Sørlandet sykehus HF Kristiansand

Kristiansand, 4615, Norway

Location

OUS, Aker

Oslo, 0586, Norway

Location

Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, 31-261, Poland

Location

UniCardia & UniMedica & UniEstetica

Krakow, 31-271, Poland

Location

Clinical Best Solutions Sp. z o.o., Sp. k

Lublin, 20-078, Poland

Location

Centrum Medyczne OMEDICA

Poznan, 60-111, Poland

Location

Uniwersytetu Medycznego im.Karola Marcinkowskiego w Poznaniu

Poznan, 61-848, Poland

Location

Velocity Nova Sp. z o.o.

Puławy, 24-100, Poland

Location

Gabinety Lekarskie LabMed

Szczecin, 71-531, Poland

Location

Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego

Warsaw, 04-628, Poland

Location

DoktorA

Warsaw, 05-077, Poland

Location

Centrum Badan Klinicznych

Wroclaw, 51-162, Poland

Location

Multispecialty Medical Clinic Anturium LLC

Barnaul, 656043, Russia

Location

Road Clinical Hospital at station Chelyabinsk

Chelyabinsk, 454048, Russia

Location

Irkutsk State Medical Academy of Postgraduate Education

Irkutsk, 664049, Russia

Location

Limited Liability Company "Alliance Biomedical Ural Group"

Izhevsk, 426061, Russia

Location

KSFMU, Inrereginal Clinical Diagnostic center

Kazan', 420010, Russia

Location

SRMC "Your Health" LLC

Kazan', 420097, Russia

Location

LLC Medical center "Maksimum Zdorovia"

Kemerovo, 650066, Russia

Location

FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

Moscow, 117292, Russia

Location

Federal Bureau for Medical and Social Expertise

Moscow, 127486, Russia

Location

Pirogov Russian National Research Medical University MoH

Moscow, 129226, Russia

Location

LLC RC Medical

Novosibirsk, 630005, Russia

Location

SGIoH of Novosibirsk region "CC Hospital #19"

Novosibirsk, 630068, Russia

Location

State Novosibirsk regional clinical hospital

Novosibirsk, 630087, Russia

Location

LLC "Clinical diagnostic center Ultramed"

Omsk, 644024, Russia

Location

Ryazan State Medical University

Ryazan, 390026, Russia

Location

Joint Stock Company "Polyclinic Complex"

Saint Petersburg, 190013, Russia

Location

Limited Liability Company "Clinic" MEDINEF "

Saint Petersburg, 194044, Russia

Location

Limited Liability Company "Energiya Zdoroviya"

Saint Petersburg, 194156, Russia

Location

St.Petersburg State Medical Academy named after Mechnikov

Saint Petersburg, 195067, Russia

Location

SGHI "Polyclinic #106"

Saint Petersburg, 198328, Russia

Location

Regional clinical cardiology dispensary

Saratov, 410028, Russia

Location

SHI Saratov City Clinical Hospital #9

Saratov, 410031, Russia

Location

Tomsk National Research Medical Center of the RAS

Tomsk, 634012, Russia

Location

Voronezh Regional Clinical Consultive-diagnostic Centre

Voronezh, 394018, Russia

Location

Polyclinic #2 in Yoshkar-Ola

Yoshkar-Ola, 424004, Russia

Location

Centro Periférico de Especialidades Bola Azul

Almería, 04009, Spain

Location

Hospital Vithas Sevilla

Castilleja de la Cuesta, 41950, Spain

Location

Hospital Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Civil de Málaga

Málaga, 29009, Spain

Location

Hospital Virgen de la Macarena

Seville, 41009, Spain

Location

Sahlgrenska US - Kärlkirurgen

Gothenburg, 413 45, Sweden

Location

Uppsala US - Kärlmottagningen

Uppsala, 751 85, Sweden

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Kuang Tien General Hospital

Taichung, 433, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital_main

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation - Linkou Branch

Taoyuan, 333, Taiwan

Location

Srinagarind Hospital

Muang, Changwat Khon Kaen, 40002, Thailand

Location

King Chulalongkorn Memorial Hospital_Cardiology

Bangkok, 10330, Thailand

Location

Phramongkutklao Hospital-cardio

Bangkok, 10400, Thailand

Location

Phramongkutklao Hospital_Cardiology

Bangkok, 10400, Thailand

Location

Research Institute for Health Sciences, CMU

Chiang Mai, 50200, Thailand

Location

RIHES-CMU_Research Institute for Health Sciences

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Maharat Nakhon Ratchasima Hospital_Cardiology

Nakhon Ratchasima, 30000, Thailand

Location

Maharat Nakhon Ratchasima Hospital_Ratchasima

Nakhon Ratchasima, 30000, Thailand

Location

Thammasat University Hospital_Pathumthani

Pathum Thani, 12120, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Peripheral Arterial Disease

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Clinical Reporting Office (2834)
Organization
Novo Nordisk A/S

Study Officials

  • Clinical Transparency (1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

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

June 5, 2026

Results First Posted

July 8, 2025

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations