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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003399-38 | Registry Identifier | European Medicines Agency (EudraCT) | |
| U1111-1238-7071 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Semaglutide given in addition to standard-of-care treatment |
|
| Placebo (semaglutide) | Placebo Comparator | Placebo given in addition to standard-of-care treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximum Walking Distance on a Constant Load Treadmill Test | Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. | Baseline (week 0), end of treatment (week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test | Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, which-ever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
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Inclusion Criteria:
Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan: Male or female, age above or equal to 20 years at time of signing informed consent
Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, PC | Birmingham | Alabama | 35211 | United States | ||
| Cardiovascular Associates of the Southeast |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40169145 | Derived | 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. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Participants were randomized in a 1:1 ratio to receive treatment with either semaglutide or placebo as an adjunct to standard-of-care.
The trial was conducted at 129 sites in 21 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Semaglutide | Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2023 | Jun 3, 2025 |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| 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. |
|
| Baseline (week 0), end of follow-up (week 57) |
| Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score | Change in VascuQoL-6 score is presented. VascuQoL-6 is a peripheral artery disease-specific questionnaire with 6 items covering social, emotional, functional as well as pain- and symptom-related aspects of the patient´s overall quality of life. Each item has a 4-point response scale (where 1 = worst score and 4 = best score). The endpoint analysed is the total score (range: 6-24) generated by summing the scores from all items. A higher score indicates better health status. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. | Baseline (week 0), end of treatment (week 52) |
| Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stopping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. | Baseline (week 0), end of treatment (week 52) |
| Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test | Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stop-ping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. | Baseline (week 0), end of follow-up (week 57) |
| Change in Glycosylated Haemoglobin (HbA1c) | Change in HbA1c from baseline to week 52 in percentage-point is presented. The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Change in Body Weight | Change in body weight from baseline to week 52 in kilogram (kg) is presented. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Change in Systolic Blood Pressure | Change in systolic blood pressure from baseline to week 52 is presented.The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Change in Total Cholesterol | Change in total cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Change in Low-density Lipoprotein (LDL)-Cholesterol | Change in LDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Change in High Density Lipoprotein (HDL)-Cholesterol | Change in HDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Change in Triglycerides | Change in Triglycerides from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Change in Ankle-Brachial Index (ABI) | Change in ABI from baseline to week 52 is presented. ABI is calculated as a ratio of the higher ankle systolic pressure to the higher systolic pressure measured in both arms. ABI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. An ABI between 1.0 to 1.4 is considered the normal range. An ABI between 0.90 to 0.99 is considered borderline. An ABI less than 0.90 indicates peripheral artery disease (PAD). The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Screening (week -2), end of treatment (week 52) |
| Change in Toe-Brachial Index (TBI) | Change in TBI from baseline to week 52 is presented. TBI is calculated as a ratio of the toe systolic pressure to the higher systolic pressure measured in both arms. TBI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. A TBI range of above or equal to 0.7 is considered normal, whereas a TBI less than 0.7 is considered abnormal. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Screening (week -2), end of treatment (week 52) |
| Change in Walking Impairment Questionnaire (WIQ) Global Score | Change in WIQ global score from baseline to week 52 is presented. WIQ consists of three domains, speed, distance, and stair climbing, consisting of in total 14 questions. Each response is weighted based on the difficulty of the task. Domain scores are determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. Global score is calculated as the mean of the three domain scores (ranged from 0% to 100%). A global score of 0% represents inabil-ity to perform any of the tasks and 100% represents no difficulty with any of the tasks. Higher scores indicate better walking ability and less impairment. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Change in Short Form 36 (SF-36) Physical Functioning Domain | Change in SF-36 physical functioning domain from baseline to week 52 is presented. SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2 (acute version) questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores (Range: 19.03 to 57.60) to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A positive change score indicates an improvement in participant health stats. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure). | Baseline (week 0), end of treatment (week 52) |
| Birmingham |
| Alabama |
| 35243 |
| United States |
| Univ of Alabama Birmingham | Birmingham | Alabama | 35294 | United States |
| Chandler Regional Medical Center | Chandler | Arizona | 85224 | United States |
| Abrazo Diabetes Care Center | Glendale | Arizona | 85308 | United States |
| Central Arkansas Veteran's Healthcare System | Little Rock | Arkansas | 72205 | United States |
| Cardio Innovation & Resch Ctr | Long Beach | California | 90813 | United States |
| Angel City Research, Inc. | Los Angeles | California | 90010 | United States |
| St. Joseph Heritage Healthcare_Mission Viejo | Mission Viejo | California | 92691 | United States |
| Adventist Hlth St Helena Hosp | St. Helena | California | 94574 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Stanford University_Stanford | Stanford | California | 94305 | United States |
| Rocky Mount Reg VA Med-DN | Aurora | Colorado | 80045 | United States |
| UC Health Heart & Vascular Center | Aurora | Colorado | 80045 | United States |
| Univ of Colorado at Denver | Aurora | Colorado | 80045 | United States |
| Bay Area Cardiology Associates, P.A. | Brandon | Florida | 33511 | United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | United States |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | United States |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | United States |
| CV Res Ctr of S Florida | Miami | Florida | 33173 | United States |
| Cardiovascular Institute of Central Florida | Ocala | Florida | 34471 | United States |
| DMI Research | Pinellas Park | Florida | 33782 | United States |
| Cardiovascular Ctr of Sarasota | Sarasota | Florida | 34239 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Accel Research Site-Georgia | Eatonton | Georgia | 31024 | United States |
| Reg Infectious Dis Infuse Ctr | La Grange | Georgia | 30240 | United States |
| Aiyan Diabetes Center | Martinez | Georgia | 30907 | United States |
| Atlanta Heart Specialists, LLC | Tucker | Georgia | 30084 | United States |
| Northwestern University_Chicago | Chicago | Illinois | 60611 | United States |
| Endeavor Health Glenbook Hosp | Glenview | Illinois | 60026 | United States |
| Central IL Diabetes and Clinical Research | Springfield | Illinois | 62701 | United States |
| Cardiovascular Rsrch of NW_IN | Munster | Indiana | 46321 | United States |
| Central Cardio Assoc HPS | Elizabethtown | Kentucky | 42701 | United States |
| Cambridge Medical Trials | Alexandria | Louisiana | 71301 | United States |
| LOUISIANA HEART Center | Covington | Louisiana | 70433 | United States |
| Clinical Trials of Ame, LLC | Monroe | Louisiana | 71201 | United States |
| Ascension Saint Agnes Heart Ca | Baltimore | Maryland | 21229 | United States |
| Boston Medical Center_Boston_1 | Boston | Massachusetts | 02118 | United States |
| Boston Medical Center_Cary | Boston | Massachusetts | 02118 | United States |
| Steward St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| Minneapolis Cardiology Assoc | Minneapolis | Minnesota | 55407-1195 | United States |
| University of Minnesota_Minneapolis_1 | Minneapolis | Minnesota | 55455 | United States |
| Amicis Centers of Clinical Research | St Louis | Missouri | 63128 | United States |
| Nebraska West Iowa Hlth System | Omaha | Nebraska | 68105 | United States |
| Methodist Phys Clin Heart Cons | Omaha | Nebraska | 68114 | United States |
| Dartmouth-Hitchcock Med Ctr | Lebanon | New Hampshire | 03766 | United States |
| NJ Heart | Linden | New Jersey | 07036 | United States |
| NYU Langone Med Assoc Chelsea | New York | New York | 10001 | United States |
| Mount Sinai Hosp at NYC | New York | New York | 10029 | United States |
| UNC- Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| NC Heart and Vascular Research | Raleigh | North Carolina | 27607 | United States |
| Accellacare_NC | Wilmington | North Carolina | 28401 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Mount Carmel Heart and Vascular | Columbus | Ohio | 43213 | United States |
| Advanced Med Res Maumee | Maumee | Ohio | 43537 | United States |
| South Oklahoma Heart Research, LLC | Oklahoma City | Oklahoma | 73135 | United States |
| Capital Area Research LLC | Camp Hill | Pennsylvania | 17011 | United States |
| Penn Presb Med Ctr | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson Univ Di Rsrch Ctr | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Vanderbilt U Med Ctr_Nashville | Nashville | Tennessee | 37232 | United States |
| PharmaTex Research | Amarillo | Texas | 79106 | United States |
| St. David's Medical Center | Austin | Texas | 78705 | United States |
| Soltero Cardiovascular Research Center | Dallas | Texas | 75226 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| UT Southwestern Med Cntr | Dallas | Texas | 75390-9302 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030-2703 | United States |
| Northwest Houston Cardiology, P.A. | Houston | Texas | 77070 | United States |
| Houston Heart & Vascular Associates | Humble | Texas | 77338 | United States |
| Texas Cardiology Associates of Houston | Kingwood | Texas | 77339 | United States |
| Texas Tech University Health Science Center | Lubbock | Texas | 79430-8183 | United States |
| North Dallas Research Associates | McKinney | Texas | 75069 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | United States |
| Univ Of Texas Hlth Science Cntr | San Antonio | Texas | 78229 | United States |
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
| San Antonio Endovascular and Heart Institute | San Antonio | Texas | 78258 | United States |
| Cardiovascular Associates East Texas | Tyler | Texas | 75701 | United States |
| Victoria Heart and Vasc Ctr | Victoria | Texas | 77901 | United States |
| Alpine Research Organization Inc | Farmington | Utah | 84025 | United States |
| Inova Heart and Vascular Institute | Falls Church | Virginia | 22042-3300 | United States |
| Carient Heart and Vascular | Manassas | Virginia | 20109 | United States |
| Roanoke Heart Institute | Roanoke | Virginia | 24014 | United States |
| Selma Medical Associates | Winchester | Virginia | 22601-3834 | United States |
| Winchester Medical Center | Winchester | Virginia | 22601 | United States |
| Aspirus Research Institute | Wausau | Wisconsin | 54401 | United States |
| Universitätsklinik für Innere Medizin Graz | Graz | 8036 | Austria |
| Univ.-Klinik für Innere Medizin III | Innsbruck | 6020 | Austria |
| Klinik Landstraße | Vienna | 1030 | Austria |
| AKH Wien | Vienna | 1090 | Austria |
| Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery | Bonheiden | 2820 | Belgium |
| Ziekenhuis Oost-Limburg AV - Thoracic | Genk | 3600 | Belgium |
| UZ Gent - Thoracale Vasculaire Heelkunde | Ghent | 9000 | Belgium |
| UZ Gent_Gent_1 | Ghent | 9000 | Belgium |
| AZ Groeninge - Thoracic Vascular Surgery | Kortrijk | 8500 | Belgium |
| UZ Leuven - Hart en Vaatziekten | Leuven | 3000 | Belgium |
| St Pauls Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Winnipeg Clinic | Winnipeg | Manitoba | R3C 0N2 | Canada |
| LMC Diabetes & Endocrinology (Barrie) | Barrie | Ontario | L4N 7L3 | Canada |
| LMC ClinRsrh Inc.Brampton | Brampton | Ontario | L6S 0C6 | Canada |
| Cambridge Cardiac Care Centre | Cambridge | Ontario | N1R 6V6 | Canada |
| Children's Hosptial London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Intrepid Health | Mississauga | Ontario | L5M 0N7 | Canada |
| LMC Research Inc. Ottawa | Nepean | Ontario | K2J 0V2 | Canada |
| North York Diagn & Cardiac Ctr | North York | Ontario | M6B 3H7 | Canada |
| North York Diagnostic and Cardiac Centre | North York | Ontario | M6B 3H7 | Canada |
| The Ottawa Hospital, Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| Kawartha Cardiology Clinical Trials | Peterborough | Ontario | K9J 0B2 | Canada |
| ViaCar Recherche Clinique Inc | Brossard | Quebec | J4Z 2K9 | Canada |
| Ecogene-21 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Clinique Sante Cardio MC | Montreal | Quebec | H1T 3Y7 | Canada |
| Recherche GCP Research | Montreal | Quebec | H1Y 3H5 | Canada |
| Montreal Heart Institute | Montreal | Quebec | QC H1T 1C8 | Canada |
| CHU de Quebec-Universite Laval | Québec | Quebec | G1J 1Z4 | Canada |
| CISSS des Laurentides | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Diex Recherche Trois-Rivieres | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| G.A. Research Associates Ltd. | Moncton | Canada |
| CHU de Quebec-Universite Laval | Québec | G1L 3L5 | Canada |
| Institut universitaire de cardiologie | Québec | G1V 4G5 | Canada |
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
| Hebei General Hospital | Shijiazhuang | Hebei | 050051 | China |
| The First Bethune hospital of Jilin University-Endocrinology | Changchun | Jilin | 130061 | China |
| The first hospital of Jilin University | Changchun | Jilin | 130061 | China |
| 1st Affiliated Hosp of Xi'an JiaoTong Uni Medical College | Xi'an | Shaanxi | 710061 | China |
| The First Affiliated Hospital of Xi'an JiaoTong University-Cardiovascular | Xi'an | Shaanxi | 710061 | China |
| Tianjin Union Medical Center-Cardiology | Tianjin | 300121 | China |
| Tianjin Union Medicine Centre | Tianjin | 300121 | China |
| Matmed s.r.o. | Hodonín | 695 01 | Czechia |
| EDUMED Jaromer | Jaroměř | 55101 | Czechia |
| Kucera | Ostrava Dubina | 700 30 | Czechia |
| Pedicor Care s.r.o. | Ostrava Dubina | 700 30 | Czechia |
| Diabetologicka ambulance Plzen | Pilsen | 301 00 | Czechia |
| II. interni klinika - klinika kardiologie a angiologie 1. LF | Prague | 128 08 | Czechia |
| Institut klinické a experimentální medicíny | Prague | 140 21 | Czechia |
| Kolding Sygehus Karkirurgi | Kolding | 6000 | Denmark |
| Rigshospitalet Karkirurgisk afd. RK 3111 | København Ø | 2100 | Denmark |
| Hjerte-, Lunge- og Karkirurgisk afdeling T | Odense | 5000 | Denmark |
| Regionshospitalet Viborg - Karkirurgisk Afsnit | Viborg | 8800 | Denmark |
| Kardiologische Praxis, Bad Homburg | Bad Homburg | 61348 | Germany |
| Herz- und Diabeteszentrum NRW - Bad Oeynhausen | Bad Oeynhausen | 32545 | Germany |
| Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden) | Dresden | 01277 | Germany |
| Uniklinik TU Dresden - Med. Klinik und Poliklinik III Angiologie | Dresden | 01307 | Germany |
| MVZ CCB Frankfurt und Main-Taunus GbR | Frankfurt | 60389 | Germany |
| Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck | Lübeck | 23538 | Germany |
| Universitätsmedizin der JGU Mainz - Kardiologie I | Mainz | 55131 | Germany |
| Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Münster | 48145 | Germany |
| Gemeinschaftspraxis Haggenmiller/Jeserich | Nuremberg | 90402 | Germany |
| Zentrum für klinische Studien Alexander Segner | Saint Ingbert-Oberwürzbach | 66386 | Germany |
| University Hospital of Athens ATTIKON | Athens | Attica | 12462 | Greece |
| "Laiko" General Hospital of Athens | Athens | 11527 | Greece |
| Konstantopouleio G.H. of Athens, "Agia Olga" | Athens | 14233 | Greece |
| "Hygeia" General Hospital of Athens | Athens | 15123 | Greece |
| General Hospital of Chios "Skilitsio" - Cardiology Clinic | Chios | 82100 | Greece |
| General Hospital of Lamia | Lamia | 35100 | Greece |
| 'Ippokrateio' General Hospital of Thessaloniki | Thessaloniki | 54642 | Greece |
| General Hospital of Thessaloniki "G.Papanikolaou" | Thessaloniki | 57010 | Greece |
| Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia | Szeged | Csongrád-Csanád | 6725 | Hungary |
| Léda Platán Magánklinika | Zalaegerszeg | Zala County | 8900 | Hungary |
| Szent Margit Rendelőintézet Nonprofit Kft. | Budapest | 1032 | Hungary |
| Szent Imre Egyetemi Oktatókórház Angiológia | Budapest | 1115 | Hungary |
| Semmelweis Egyetem Városmajori Szív- és Érgyógyászat | Budapest | 1122 | Hungary |
| Coromed SMO Kft. | Pécs | 7623 | Hungary |
| Sanjeevani Superspeciality Hospital | Ahmedabad | Gujarat | 380015 | India |
| Shri B D Mehta Mahavir Heart Institute | Surat | Gujarat | 395001 | India |
| Shri B. D. Mehta Mahavir Heart Institute | Surat | Gujarat | 395001 | India |
| Unicare heart institute and research centre | Surat | Gujarat | 395001 | India |
| Nirmal Hospital Pvt. Ltd. | Surat | Gujarat | 395002 | India |
| Ramaiah Memorial Hospital | Bangalore | Karnataka | 560054 | India |
| Sri Jayadeva Institute of Cardiovascular Sciences & Research | Bengaluru | Karnataka | 560069 | India |
| Seth GS medical college and KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| Shri Krishna Hrudayalaya & Critical Care Centre | Nagpur | Maharashtra | 440012 | India |
| Shrikrishna Hrudayalaya and critical care centre | Nagpur | Maharashtra | 440012 | India |
| Vijan Hospital & Research Centre | Nashik | Maharashtra | 422005 | India |
| Grant Medical Foundation | Pune | Maharashtra | 411001 | India |
| G B Pant Institute of Postgraduate Medical Education and Research | New Delhi | National Capital Territory of Delhi | 110002 | India |
| Batra Hospital and Medical Research Center | New Delhi | National Capital Territory of Delhi | 110062 | India |
| VMMC & Safdarjung Hospital | New Dehli | New Delhi | 110029 | India |
| Post Graduate Institute of Medical Education & Research | Chandigarh | Punjab | 160012 | India |
| Dayanand Medical College & Hospital | Ludhiana | Punjab | 141001 | India |
| SP Medical College | Bikaner | Rajasthan | 334003 | India |
| Eternal Heart Care Centre | Jaipur | Rajasthan | 302017 | India |
| M.V.Hospital for Diabetes Pvt. Ltd. | Chennai | Tamil Nadu | 600 013 | India |
| Osmania General Hospital | Hyderabad | Telangana | 500012 | India |
| Udyaan Health Care | Lucknow | Uttar Pradesh | 226002 | India |
| Gandhi Memorial Hospital- King George's Medical University | Lucknow | Uttar Pradesh | 226003 | India |
| Care Hospital | Hyderabad | 600034 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| New Tokyo Heart Clinic_Cardiology | Chiba | 271-0077 | Japan |
| New Tokyo Heart Clinic_Matsudo-shi, Chiba, | Chiba | 271-0077 | Japan |
| Akaicho Clinic | Chiba-shi, Chiba | 260-0804 | Japan |
| Takahashi Hospital_Cardiology | Hyōgo | 654-0026 | Japan |
| Higashi Takarazuka Satoh Hospital_Cardiology | Hyōgo | 665-0873 | Japan |
| Higashi Takarazuka Satoh Hospital | Hyōgo | 665-0873 | Japan |
| Naka Kinen Clinic_Internal medicine | Ibaraki | 311-0113 | Japan |
| Naka Kinen Clinic | Ibaraki | 311-0113 | Japan |
| Nishiyamado Keiwa Hospital_Internal Medicine | Ibaraki | 331-0133 | Japan |
| Omihachiman Community Medical Center_Cardiovascular Medicine | Omihachiman-shi, Siga | 523-0082 | Japan |
| Omihachiman Community Medical Center_Omihachiman-shi, Siga | Omihachiman-shi, Siga | 523-0082 | Japan |
| Minamiosaka Hospital_Internal medicine | Osaka | 559-0012 | Japan |
| Saitama Cardiovascular and Respiratory Center | Saitama | 360-0197 | Japan |
| Omi Medical Center_Cardiovascular Medicine | Shiga | 525-8585 | Japan |
| Omi Medical Center | Shiga | 525-8585 | Japan |
| Minamino Cardiovascular Hospital_Cardiovascular medicine | Tokyo | 192-0918 | Japan |
| P. Stradins Clinical University Hospital | Riga | 1002 | Latvia |
| Stradini PAD | Riga | LV-1002 | Latvia |
| Health Center-4 | Riga | LV1012 | Latvia |
| Hospital Universiti Sains Malaysia | Kota Bharu | Kelantan | 16150 | Malaysia |
| University Malaya Medical Centre | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
| Hospital Tengku Ampuan Afzan | Kuantan | Pahang | 25100 | Malaysia |
| Hospital Pulau Pinang | George Town | Pulau Pinang | 10990 | Malaysia |
| Hospital Serdang | Serdang | Selangor | 43000 | Malaysia |
| Sunway Medical Centre | Subang Jaya | Selangor | 47500 | Malaysia |
| University Technology MARA (UiTM) - Sg Buloh | Sungai Buloh | Selangor | 47000 | Malaysia |
| National Heart Institute | Kuala Lumpur | 50400 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Hospital Queen Elizabeth II | Sabak Bernam | 88300 | Malaysia |
| Haukeland universitetssykehus - Karkirurgisk avdeling | Bergen | 5021 | Norway |
| Sørlandet sykehus HF Kristiansand | Kristiansand | 4615 | Norway |
| OUS, Aker | Oslo | 0586 | Norway |
| Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET | Krakow | Lesser Poland Voivodeship | 31-261 | Poland |
| UniCardia & UniMedica & UniEstetica | Krakow | 31-271 | Poland |
| Clinical Best Solutions Sp. z o.o., Sp. k | Lublin | 20-078 | Poland |
| Centrum Medyczne OMEDICA | Poznan | 60-111 | Poland |
| Uniwersytetu Medycznego im.Karola Marcinkowskiego w Poznaniu | Poznan | 61-848 | Poland |
| Velocity Nova Sp. z o.o. | Puławy | 24-100 | Poland |
| Gabinety Lekarskie LabMed | Szczecin | 71-531 | Poland |
| Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego | Warsaw | 04-628 | Poland |
| DoktorA | Warsaw | 05-077 | Poland |
| Centrum Badan Klinicznych | Wroclaw | 51-162 | Poland |
| Multispecialty Medical Clinic Anturium LLC | Barnaul | 656043 | Russia |
| Road Clinical Hospital at station Chelyabinsk | Chelyabinsk | 454048 | Russia |
| Irkutsk State Medical Academy of Postgraduate Education | Irkutsk | 664049 | Russia |
| Limited Liability Company "Alliance Biomedical Ural Group" | Izhevsk | 426061 | Russia |
| KSFMU, Inrereginal Clinical Diagnostic center | Kazan' | 420010 | Russia |
| SRMC "Your Health" LLC | Kazan' | 420097 | Russia |
| LLC Medical center "Maksimum Zdorovia" | Kemerovo | 650066 | Russia |
| FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia | Moscow | 117292 | Russia |
| Federal Bureau for Medical and Social Expertise | Moscow | 127486 | Russia |
| Pirogov Russian National Research Medical University MoH | Moscow | 129226 | Russia |
| LLC RC Medical | Novosibirsk | 630005 | Russia |
| SGIoH of Novosibirsk region "CC Hospital #19" | Novosibirsk | 630068 | Russia |
| State Novosibirsk regional clinical hospital | Novosibirsk | 630087 | Russia |
| LLC "Clinical diagnostic center Ultramed" | Omsk | 644024 | Russia |
| Ryazan State Medical University | Ryazan | 390026 | Russia |
| Joint Stock Company "Polyclinic Complex" | Saint Petersburg | 190013 | Russia |
| Limited Liability Company "Clinic" MEDINEF " | Saint Petersburg | 194044 | Russia |
| Limited Liability Company "Energiya Zdoroviya" | Saint Petersburg | 194156 | Russia |
| St.Petersburg State Medical Academy named after Mechnikov | Saint Petersburg | 195067 | Russia |
| SGHI "Polyclinic #106" | Saint Petersburg | 198328 | Russia |
| Regional clinical cardiology dispensary | Saratov | 410028 | Russia |
| SHI Saratov City Clinical Hospital #9 | Saratov | 410031 | Russia |
| Tomsk National Research Medical Center of the RAS | Tomsk | 634012 | Russia |
| Voronezh Regional Clinical Consultive-diagnostic Centre | Voronezh | 394018 | Russia |
| Polyclinic #2 in Yoshkar-Ola | Yoshkar-Ola | 424004 | Russia |
| Centro Periférico de Especialidades Bola Azul | Almería | 04009 | Spain |
| Hospital Vithas Sevilla | Castilleja de la Cuesta | 41950 | Spain |
| Hospital Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital Gregorio Marañón | Madrid | 28009 | Spain |
| Hospital Civil de Málaga | Málaga | 29009 | Spain |
| Hospital Virgen de la Macarena | Seville | 41009 | Spain |
| Sahlgrenska US - Kärlkirurgen | Gothenburg | 413 45 | Sweden |
| Uppsala US - Kärlmottagningen | Uppsala | 751 85 | Sweden |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| Kuang Tien General Hospital | Taichung | 433 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital_main | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Chang Gung Medical Foundation - Linkou Branch | Taoyuan | 333 | Taiwan |
| Srinagarind Hospital | Muang | Changwat Khon Kaen | 40002 | Thailand |
| King Chulalongkorn Memorial Hospital_Cardiology | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital-cardio | Bangkok | 10400 | Thailand |
| Phramongkutklao Hospital_Cardiology | Bangkok | 10400 | Thailand |
| Research Institute for Health Sciences, CMU | Chiang Mai | 50200 | Thailand |
| RIHES-CMU_Research Institute for Health Sciences | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Maharat Nakhon Ratchasima Hospital_Cardiology | Nakhon Ratchasima | 30000 | Thailand |
| Maharat Nakhon Ratchasima Hospital_Ratchasima | Nakhon Ratchasima | 30000 | Thailand |
| Thammasat University Hospital_Pathumthani | Pathum Thani | 12120 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Placebo |
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. |
| Full Analysis Set | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. |
|
| Safety Analysis Set |
|
| COMPLETED | Participants attended follow-up visit or died during trial considered completers in the trial. |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Semaglutide | Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg. |
| BG001 | Placebo | Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Median | Inter-Quartile Range | Ratio of maximum walking distance | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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. | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Median | Inter-Quartile Range | Ratio of maximum walking distance | Baseline (week 0), end of follow-up (week 57) |
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| Secondary | 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. | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Median | Inter-Quartile Range | Scores on a scale | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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. | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Median | Inter-Quartile Range | Ratio of pain-free walking distance | Baseline (week 0), end of treatment (week 52) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Median | Inter-Quartile Range | Ratio of pain-free walking distance | Baseline (week 0), end of follow-up (week 57) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage-point of HbA1c | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Kilogram (kg) | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Millimetre of mercury (mmHg) | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of total cholesterol | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of LDL | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of HDL | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of triglycerides | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of ABI | Screening (week -2), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of TBI | Screening (week -2), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | %-point scores on a scale | Baseline (week 0), end of treatment (week 52) |
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| Secondary | 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). | Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (week 0), end of treatment (week 52) |
|
Until week 57
All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Semaglutide | Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg. | 4 | 396 | 74 | 396 | 47 | 396 |
| EG001 | Placebo | Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. | 9 | 395 | 78 | 395 | 24 | 395 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Abdominal symptom | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Bladder cancer stage 0, with cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Carotid artery restenosis | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 27 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Lung adenocarcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Lung adenocarcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | MedDRA 27 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Scrotal ulcer | Reproductive system and breast disorders | MedDRA 27 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Septic endocarditis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Stomach mass | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Tissue discolouration | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 27 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2024 | Jun 3, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Other |
|
| Placebo |
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. |
|
|
|
| Placebo |
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. |
|
|
|
| Placebo |
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. |
|
|
|
| Placebo |
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. |
|
|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
| Placebo |
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. |
|
|
| OG001 |
| Placebo |
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks. |
|
|