Diabetes Mellitus, Type 2Phase 3STRIDENCT04560998
A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2 and Peripheral Arterial Disease, run by Novo Nordisk A/S at 283 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Peripheral Arterial Disease
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 792 participants
- Where
- 283 sitesin 21 countries
- Study dates
- 1 Oct 2020to 12 Jul 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
283 sites in 21 countries.
283 sites in 21 countries
United States88 sites
Cambridge Medical Trials
Alexandria, Louisiana, 71301
PharmaTex Research
Amarillo, Texas, 79106
Piedmont Heart Institute
Atlanta, Georgia, 30309
Rocky Mount Reg VA Med-DN
Aurora, Colorado, 80045
UC Health Heart & Vascular Center
Aurora, Colorado, 80045
Univ of Colorado at Denver
Aurora, Colorado, 80045
St. David's Medical Center
Austin, Texas, 78705
Ascension Saint Agnes Heart Ca
Baltimore, Maryland, 21229
Cardiology, PC
Birmingham, Alabama, 35211
Cardiovascular Associates of the Southeast
Birmingham, Alabama, 35243
Univ of Alabama Birmingham
Birmingham, Alabama, 35294
Boston Medical Center_Boston_1
Boston, Massachusetts, 02118
Boston Medical Center_Cary
Boston, Massachusetts, 02118
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Bay Area Cardiology Associates, P.A.
Brandon, Florida, 33511
Capital Area Research LLC
Camp Hill, Pennsylvania, 17011
Chandler Regional Medical Center
Chandler, Arizona, 85224
UNC- Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University_Chicago
Chicago, Illinois, 60611
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Tampa Bay Medical Research
Clearwater, Florida, 33761
MetroHealth Medical Center
Cleveland, Ohio, 44109
Mount Carmel Heart and Vascular
Columbus, Ohio, 43213
LOUISIANA HEART Center
Covington, Louisiana, 70433
Soltero Cardiovascular Research Center
Dallas, Texas, 75226
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302
UT Southwestern
Dallas, Texas, 75390
Accel Research Site-Georgia
Eatonton, Georgia, 31024
Central Cardio Assoc HPS
Elizabethtown, Kentucky, 42701
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042-3300
Lillestol Research LLC
Fargo, North Dakota, 58104
Alpine Research Organization Inc
Farmington, Utah, 84025
Abrazo Diabetes Care Center
Glendale, Arizona, 85308
Endeavor Health Glenbook Hosp
Glenview, Illinois, 60026
Houston Methodist Hospital
Houston, Texas, 77030-2703
Northwest Houston Cardiology, P.A.
Houston, Texas, 77070
Houston Heart & Vascular Associates
Humble, Texas, 77338
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339
Reg Infectious Dis Infuse Ctr
La Grange, Georgia, 30240
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03766
NJ Heart
Linden, New Jersey, 07036
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205
Cardio Innovation & Resch Ctr
Long Beach, California, 90813
Angel City Research, Inc.
Los Angeles, California, 90010
Texas Tech University Health Science Center
Lubbock, Texas, 79430-8183
Carient Heart and Vascular
Manassas, Virginia, 20109
Aiyan Diabetes Center
Martinez, Georgia, 30907
Advanced Med Res Maumee
Maumee, Ohio, 43537
North Dallas Research Associates
McKinney, Texas, 75069
CV Res Ctr of S Florida
Miami, Florida, 33173
Minneapolis Cardiology Assoc
Minneapolis, Minnesota, 55407-1195
University of Minnesota_Minneapolis_1
Minneapolis, Minnesota, 55455
St. Joseph Heritage Healthcare_Mission Viejo
Mission Viejo, California, 92691
Clinical Trials of Ame, LLC
Monroe, Louisiana, 71201
Cardiovascular Rsrch of NW_IN
Munster, Indiana, 46321
Vanderbilt U Med Ctr_Nashville
Nashville, Tennessee, 37232
NYU Langone Med Assoc Chelsea
New York, New York, 10001
Mount Sinai Hosp at NYC
New York, New York, 10029
Cardiovascular Institute of Central Florida
Ocala, Florida, 34471
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135
Nebraska West Iowa Hlth System
Omaha, Nebraska, 68105
Methodist Phys Clin Heart Cons
Omaha, Nebraska, 68114
Penn Presb Med Ctr
Philadelphia, Pennsylvania, 19104
Thomas Jefferson Univ Di Rsrch Ctr
Philadelphia, Pennsylvania, 19107
Temple University Hospital
Philadelphia, Pennsylvania, 19140
DMI Research
Pinellas Park, Florida, 33782
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
Roanoke Heart Institute
Roanoke, Virginia, 24014
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Univ Of Texas Hlth Science Cntr
San Antonio, Texas, 78229
UT Health San Antonio
San Antonio, Texas, 78229
San Antonio Endovascular and Heart Institute
San Antonio, Texas, 78258
Cardiovascular Ctr of Sarasota
Sarasota, Florida, 34239
Central IL Diabetes and Clinical Research
Springfield, Illinois, 62701
Amicis Centers of Clinical Research
St Louis, Missouri, 63128
Adventist Hlth St Helena Hosp
St. Helena, California, 94574
Stanford University Medical Center
Stanford, California, 94305
Stanford University_Stanford
Stanford, California, 94305
University of South Florida
Tampa, Florida, 33606
Atlanta Heart Specialists, LLC
Tucker, Georgia, 30084
Cardiovascular Associates East Texas
Tyler, Texas, 75701
Victoria Heart and Vasc Ctr
Victoria, Texas, 77901
Aspirus Research Institute
Wausau, Wisconsin, 54401
Accellacare_NC
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601-3834
Winchester Medical Center
Winchester, Virginia, 22601
India25 sites
Sanjeevani Superspeciality Hospital
Ahmedabad, Gujarat, 380015
Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bengaluru, Karnataka, 560069
SP Medical College
Bikaner, Rajasthan, 334003
Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, 160012
M.V.Hospital for Diabetes Pvt. Ltd.
Chennai, Tamil Nadu, 600 013
Osmania General Hospital
Hyderabad, Telangana, 500012
Care Hospital
Hyderabad, 600034
Eternal Heart Care Centre
Jaipur, Rajasthan, 302017
Udyaan Health Care
Lucknow, Uttar Pradesh, 226002
Gandhi Memorial Hospital- King George's Medical University
Lucknow, Uttar Pradesh, 226003
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, 400012
Shri Krishna Hrudayalaya & Critical Care Centre
Nagpur, Maharashtra, 440012
Shrikrishna Hrudayalaya and critical care centre
Nagpur, Maharashtra, 440012
Vijan Hospital & Research Centre
Nashik, Maharashtra, 422005
VMMC & Safdarjung Hospital
New Dehli, New Delhi, 110029
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi, National Capital Territory of Delhi, 110002
Batra Hospital and Medical Research Center
New Delhi, National Capital Territory of Delhi, 110062
Sir Ganga Ram Hospital
New Delhi, 110060
Grant Medical Foundation
Pune, Maharashtra, 411001
Shri B D Mehta Mahavir Heart Institute
Surat, Gujarat, 395001
Shri B. D. Mehta Mahavir Heart Institute
Surat, Gujarat, 395001
Unicare heart institute and research centre
Surat, Gujarat, 395001
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002
Russia25 sites
Multispecialty Medical Clinic Anturium LLC
Barnaul, 656043
Road Clinical Hospital at station Chelyabinsk
Chelyabinsk, 454048
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk, 664049
Limited Liability Company "Alliance Biomedical Ural Group"
Izhevsk, 426061
KSFMU, Inrereginal Clinical Diagnostic center
Kazan', 420010
SRMC "Your Health" LLC
Kazan', 420097
LLC Medical center "Maksimum Zdorovia"
Kemerovo, 650066
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, 117292
Federal Bureau for Medical and Social Expertise
Moscow, 127486
Pirogov Russian National Research Medical University MoH
Moscow, 129226
LLC RC Medical
Novosibirsk, 630005
SGIoH of Novosibirsk region "CC Hospital #19"
Novosibirsk, 630068
State Novosibirsk regional clinical hospital
Novosibirsk, 630087
LLC "Clinical diagnostic center Ultramed"
Omsk, 644024
Ryazan State Medical University
Ryazan, 390026
Joint Stock Company "Polyclinic Complex"
Saint Petersburg, 190013
Limited Liability Company "Clinic" MEDINEF "
Saint Petersburg, 194044
Limited Liability Company "Energiya Zdoroviya"
Saint Petersburg, 194156
St.Petersburg State Medical Academy named after Mechnikov
Saint Petersburg, 195067
SGHI "Polyclinic #106"
Saint Petersburg, 198328
Regional clinical cardiology dispensary
Saratov, 410028
SHI Saratov City Clinical Hospital #9
Saratov, 410031
Tomsk National Research Medical Center of the RAS
Tomsk, 634012
Voronezh Regional Clinical Consultive-diagnostic Centre
Voronezh, 394018
Polyclinic #2 in Yoshkar-Ola
Yoshkar-Ola, 424004
Canada23 sites
LMC Diabetes & Endocrinology (Barrie)
Barrie, Ontario, L4N 7L3
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, L6S 0C6
ViaCar Recherche Clinique Inc
Brossard, Quebec, J4Z 2K9
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
Children's Hosptial London Health Sciences Centre
London, Ontario, N6A 5W9
Intrepid Health
Mississauga, Ontario, L5M 0N7
G.A. Research Associates Ltd.
Moncton
Clinique Sante Cardio MC
Montreal, Quebec, H1T 3Y7
Recherche GCP Research
Montreal, Quebec, H1Y 3H5
Montreal Heart Institute
Montreal, Quebec, QC H1T 1C8
LMC Research Inc. Ottawa
Nepean, Ontario, K2J 0V2
North York Diagn & Cardiac Ctr
North York, Ontario, M6B 3H7
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
CHU de Quebec-Universite Laval
Québec, Quebec, G1J 1Z4
CHU de Quebec-Universite Laval
Québec, G1L 3L5
Institut universitaire de cardiologie
Québec, G1V 4G5
CISSS des Laurentides
Saint-Jérôme, Quebec, J7Z 5T3
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, G8Z 3R9
St Pauls Hospital
Vancouver, British Columbia, V6Z 1Y6
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Japan16 sites
New Tokyo Heart Clinic_Cardiology
Chiba, 271-0077
New Tokyo Heart Clinic_Matsudo-shi, Chiba,
Chiba, 271-0077
Akaicho Clinic
Chiba-shi, Chiba, 260-0804
Takahashi Hospital_Cardiology
Hyōgo, 654-0026
Higashi Takarazuka Satoh Hospital_Cardiology
Hyōgo, 665-0873
Higashi Takarazuka Satoh Hospital
Hyōgo, 665-0873
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113
Naka Kinen Clinic
Ibaraki, 311-0113
Nishiyamado Keiwa Hospital_Internal Medicine
Ibaraki, 331-0133
Omihachiman Community Medical Center_Cardiovascular Medicine
Omihachiman-shi, Siga, 523-0082
Omihachiman Community Medical Center_Omihachiman-shi, Siga
Omihachiman-shi, Siga, 523-0082
Minamiosaka Hospital_Internal medicine
Osaka, 559-0012
Saitama Cardiovascular and Respiratory Center
Saitama, 360-0197
Omi Medical Center_Cardiovascular Medicine
Shiga, 525-8585
Omi Medical Center
Shiga, 525-8585
Minamino Cardiovascular Hospital_Cardiovascular medicine
Tokyo, 192-0918
Thailand11 sites
King Chulalongkorn Memorial Hospital_Cardiology
Bangkok, 10330
Phramongkutklao Hospital-cardio
Bangkok, 10400
Phramongkutklao Hospital_Cardiology
Bangkok, 10400
Research Institute for Health Sciences, CMU
Chiang Mai, 50200
RIHES-CMU_Research Institute for Health Sciences
Chiang Mai, 50200
Srinagarind Hospital
Khon Kaen, 40002
Srinagarind Hospital
Muang, Changwat Khon Kaen, 40002
Maharat Nakhon Ratchasima Hospital_Cardiology
Nakhon Ratchasima, 30000
Maharat Nakhon Ratchasima Hospital_Ratchasima
Nakhon Ratchasima, 30000
Thammasat University Hospital_Pathumthani
Pathum Thani, 12120
Songklanagarind Hospital
Songkhla, 90110
Germany10 sites
Kardiologische Praxis, Bad Homburg
Bad Homburg, 61348
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, 32545
Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden)
Dresden, 01277
Uniklinik TU Dresden - Med. Klinik und Poliklinik III Angiologie
Dresden, 01307
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, 60389
Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, 23538
Universitätsmedizin der JGU Mainz - Kardiologie I
Mainz, 55131
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145
Gemeinschaftspraxis Haggenmiller/Jeserich
Nuremberg, 90402
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386
Malaysia10 sites
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
National Heart Institute
Kuala Lumpur, 50400
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
Hospital Queen Elizabeth II
Sabak Bernam, 88300
Hospital Serdang
Serdang, Selangor, 43000
Sunway Medical Centre
Subang Jaya, Selangor, 47500
University Technology MARA (UiTM) - Sg Buloh
Sungai Buloh, Selangor, 47000
Poland10 sites
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261
UniCardia & UniMedica & UniEstetica
Krakow, 31-271
Clinical Best Solutions Sp. z o.o., Sp. k
Lublin, 20-078
Centrum Medyczne OMEDICA
Poznan, 60-111
Uniwersytetu Medycznego im.Karola Marcinkowskiego w Poznaniu
Poznan, 61-848
Velocity Nova Sp. z o.o.
Puławy, 24-100
Gabinety Lekarskie LabMed
Szczecin, 71-531
Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego
Warsaw, 04-628
DoktorA
Warsaw, 05-077
Centrum Badan Klinicznych
Wroclaw, 51-162
China8 sites
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Jilin, 130061
The first hospital of Jilin University
Changchun, Jilin, 130061
Hebei General Hospital
Shijiazhuang, Hebei, 050051
Tianjin Union Medical Center-Cardiology
Tianjin, 300121
Tianjin Union Medicine Centre
Tianjin, 300121
1st Affiliated Hosp of Xi'an JiaoTong Uni Medical College
Xi'an, Shaanxi, 710061
The First Affiliated Hospital of Xi'an JiaoTong University-Cardiovascular
Xi'an, Shaanxi, 710061
Greece8 sites
University Hospital of Athens ATTIKON
Athens, Attica, 12462
"Laiko" General Hospital of Athens
Athens, 11527
Konstantopouleio G.H. of Athens, "Agia Olga"
Athens, 14233
"Hygeia" General Hospital of Athens
Athens, 15123
General Hospital of Chios "Skilitsio" - Cardiology Clinic
Chios, 82100
General Hospital of Lamia
Lamia, 35100
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, 54642
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, 57010
Czechia7 sites
Matmed s.r.o.
Hodonín, 695 01
EDUMED Jaromer
Jaroměř, 55101
Kucera
Ostrava Dubina, 700 30
Pedicor Care s.r.o.
Ostrava Dubina, 700 30
Diabetologicka ambulance Plzen
Pilsen, 301 00
II. interni klinika - klinika kardiologie a angiologie 1. LF
Prague, 128 08
Institut klinické a experimentální medicíny
Prague, 140 21
Spain7 sites
Centro Periférico de Especialidades Bola Azul
Almería, 04009
Hospital Vithas Sevilla
Castilleja de la Cuesta, 41950
Hospital Reina Sofia
Córdoba, 14004
Hospital Universitario de la Princesa
Madrid, 28006
Hospital Gregorio Marañón
Madrid, 28009
Hospital Civil de Málaga
Málaga, 29009
Hospital Virgen de la Macarena
Seville, 41009
Taiwan7 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
China Medical University Hospital
Taichung, 404
Kuang Tien General Hospital
Taichung, 433
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital_main
Taipei, 100
Taipei Veterans General Hospital
Taipei, 112
Chang Gung Medical Foundation - Linkou Branch
Taoyuan, 333
Belgium6 sites
Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery
Bonheiden, 2820
Ziekenhuis Oost-Limburg AV - Thoracic
Genk, 3600
UZ Gent - Thoracale Vasculaire Heelkunde
Ghent, 9000
UZ Gent_Gent_1
Ghent, 9000
AZ Groeninge - Thoracic Vascular Surgery
Kortrijk, 8500
UZ Leuven - Hart en Vaatziekten
Leuven, 3000
Hungary6 sites
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest, 1032
Szent Imre Egyetemi Oktatókórház Angiológia
Budapest, 1115
Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
Budapest, 1122
Coromed SMO Kft.
Pécs, 7623
Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia
Szeged, Csongrád-Csanád, 6725
Léda Platán Magánklinika
Zalaegerszeg, Zala County, 8900
Austria4 sites
Universitätsklinik für Innere Medizin Graz
Graz, 8036
Univ.-Klinik für Innere Medizin III
Innsbruck, 6020
Klinik Landstraße
Vienna, 1030
AKH Wien
Vienna, 1090
Denmark4 sites
Rigshospitalet Karkirurgisk afd. RK 3111
København Ø, 2100
Kolding Sygehus Karkirurgi
Kolding, 6000
Hjerte-, Lunge- og Karkirurgisk afdeling T
Odense, 5000
Regionshospitalet Viborg - Karkirurgisk Afsnit
Viborg, 8800
Latvia3 sites
P. Stradins Clinical University Hospital
Riga, 1002
Stradini PAD
Riga, LV-1002
Health Center-4
Riga, LV1012
Norway3 sites
Haukeland universitetssykehus - Karkirurgisk avdeling
Bergen, 5021
Sørlandet sykehus HF Kristiansand
Kristiansand, 4615
OUS, Aker
Oslo, 0586
Sweden2 sites
Sahlgrenska US - Kärlkirurgen
Gothenburg, 413 45
Uppsala US - Kärlmottagningen
Uppsala, 751 85
About this study
Official title: 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.
- Being tested
- Semaglutide, Placebo (semaglutide)
- Medical subject headings
- Diabetes Mellitus, Type 2, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Semaglutide given in addition to standard-of-care treatment Receives: Drug: Semaglutide |
| Placebo (semaglutide) | Placebo comparator | Placebo given in addition to standard-of-care treatment Receives: Drug: Placebo (semaglutide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0), end of treatment (week 52)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (week 0), end of treatment (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Oct 2020
- Primary completion5 Jun 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560998
- Sponsor's protocol ID
- NN9535-4533
- Other IDs
- 2019-003399-38, U1111-1238-7071, 2019
- Acronym
- STRIDE
- Status last verified
- May 2026
- First submitted
- 18 Sep 2020
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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.
PubMed 40169145