Clinical trial NCT04560998: A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
Official title: Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Peripheral Arterial Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria: 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:

  1. 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.
  2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.
  3. 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.
  4. 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in maximum walking distance on a constant load treadmill test
timeFrame: From baseline (week 0) to end of treatment (week 52)
Secondary outcomes:
measure: Follow-up change in maximum walking distance on a constant load treadmill test
timeFrame: From baseline (week 0) to end of follow-up (week 57)
measure: Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in pain-free walking distance on a constant load treadmill test
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Follow-up change in pain-free walking distance on a constant load treadmill test
timeFrame: From baseline (week 0) to end of follow-up (week 57)
measure: Change in glycosylated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in Low-density lipoprotein (LDL)- cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in High density lipoprotein (HDL)- cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in ankle-brachial index (ABI)
timeFrame: From screening (week -2) to end of treatment (week 52)
measure: Change in toe-brachial index (TBI)
timeFrame: From screening (week -2) to end of treatment (week 52)
measure: Change in Walking Impairment Questionnaire (WIQ) global score
timeFrame: From baseline (week 0) to end of treatment (week 52)
measure: Change in Short Form 36 (SF-36) physical functioning domain
timeFrame: From baseline (week 0) to end of treatment (week 52)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Angel City Research, Inc.
state: California
city: Mission Viejo
country: United States
facility: St. Joseph Heritage Healthcare_Mission Viejo
state: California
city: Aurora
country: United States
facility: Rocky Mount Reg VA Med-DN
state: Colorado
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Martinez
country: United States
facility: Aiyan Diabetes Center
state: Georgia
city: Glenview
country: United States
facility: Endeavor Health Glenbook Hosp
state: Illinois
city: Munster
country: United States
facility: Cardiovascular Rsrch of NW_IN
state: Indiana
city: Covington
country: United States
facility: LOUISIANA HEART Center
state: Louisiana
city: Saint Louis
country: United States
facility: Amicis Centers of Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Nebraska West Iowa Hlth System
state: Nebraska
city: Camp Hill
country: United States
facility: Capital Area Research LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presb Med Ctr
state: Pennsylvania
city: Houston
country: United States
facility: Northwest Houston Cardiology, P.A.
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Science Center
state: Texas
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Graz
country: Austria
facility: Universitätsklinik für Innere Medizin Graz
city: Wien
country: Austria
facility: Klinik Landstraße
city: Wien
country: Austria
facility: AKH Wien
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg AV - Thoracic
city: Gent
country: Belgium
facility: UZ Gent - Thoracale Vasculaire Heelkunde
city: Gent
country: Belgium
facility: UZ Gent_Gent_1
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Thoracic Vascular Surgery
city: Leuven
country: Belgium
facility: UZ Leuven - Hart en Vaatziekten
city: North York
country: Canada
facility: North York Diagn & Cardiac Ctr
state: Ontario
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre
state: Ontario
city: Brossard
country: Canada
facility: ViaCar Recherche Clinique Inc
state: Quebec
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Montreal
country: Canada
facility: Clinique Sante Cardio MC
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: 1st Affiliated Hosp of Xi'an JiaoTong Uni Medical College
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University-Cardiovascular
state: Shaanxi
city: Tianjin
country: China
facility: Tianjin Union Medical Center-Cardiology
city: Tianjin
country: China
facility: Tianjin Union Medicine Centre
city: Hodonin
country: Czechia
facility: CTC Hodonin s.r.o.
city: Jaroměř
country: Czechia
facility: EDUMED Jaromer
city: Ostrava Dubina
country: Czechia
facility: Kucera
city: Plzen
country: Czechia
facility: Diabetologicka ambulance Plzen
city: Kolding
country: Denmark
facility: Kolding Sygehus Karkirurgi
city: København Ø
country: Denmark
facility: Rigshospitalet Karkirurgisk afd. RK 3111
city: Viborg
country: Denmark
facility: Karkirurgisk Afsnit
city: Bad Homburg
country: Germany
facility: Kardiologische Praxis
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen
city: Dresden
country: Germany
facility: Kreutzmann
city: Dresden
country: Germany
facility: Medizinische Klinik und Poliklinik III/Angiologie TU Dresden
city: Frankfurt
country: Germany
facility: MVZ CCB Frankfurt Und Main-Taunus GbR
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Nürnberg
country: Germany
facility: Gemeinschaftspraxis Haggenmiller/Jeserich
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Zentrum für klinische Studien Alexander Segner
city: Haidari-Athens
country: Greece
facility: University Hospital of Athens ATTIKON
state: Attica
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: Konstantopouleio G.H. of Athens, "Agia Olga"
city: Athens
country: Greece
facility: "Hygeia" General Hospital of Athens
city: Chios
country: Greece
facility: General Hospital of Chios "Skilitsio"
city: Lamia
country: Greece
facility: General Hospital of Lamia
city: Thessaloniki
country: Greece
facility: 'Ippokrateio' General Hospital of Thessaloniki
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia
state: Csongrád-Csanád
city: Zalaegerszeg
country: Hungary
facility: Léda Platán Magánklinika
state: Zala Megye
city: Budapest
country: Hungary
facility: Szent Margit Rendelőintézet Nonprofit Kft.
city: Budapest
country: Hungary
facility: Szent Imre Egyetemi Oktatókórház Angiológia
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
city: Pécs
country: Hungary
facility: Coromed SMO Kft.
city: Surat
country: India
facility: Shri B D Mehta Mahavir Heart Institute
state: Gujarat
city: Surat
country: India
facility: Shri B. D. Mehta Mahavir Heart Institute
state: Gujarat
city: Nagpur
country: India
facility: Shri Krishna Hrudayalaya & Critical Care Centre
state: Maharashtra
city: Nagpur
country: India
facility: Shrikrishna Hrudayalaya and critical care centre
state: Maharashtra
city: Nashik
country: India
facility: Vijan Hospital & Research Centre
state: Maharashtra
city: Bikaner
country: India
facility: SP Medical College
state: Rajasthan
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telangana
city: Lucknow
country: India
facility: Udyaan Health Care
state: Uttar Pradesh
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Chiba-shi, Chiba
country: Japan
facility: Akaicho Clinic
city: Chiba
country: Japan
facility: New Tokyo Heart Clinic_Matsudo-shi, Chiba,
city: Hyogo
country: Japan
facility: Higashi Takarazuka Satoh Hospital
city: Ibaraki,
country: Japan
facility: Nishiyamado Keiwa Hospital
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Omihachiman-shi, Siga
country: Japan
facility: Omihachiman Community Medical Center_Omihachiman-shi, Siga
city: Osaka
country: Japan
facility: Minamiosaka Hospital
city: Saitama
country: Japan
facility: Saitama Cardiovascular and Respiratory Center
city: Shiga
country: Japan
facility: Omi Medical Center
city: Tokyo
country: Japan
facility: Minamino Cardiovascular Hospital
city: Riga
country: Latvia
facility: Stradini PAD
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: National Heart Institute
city: Sabah
country: Malaysia
facility: Hospital Queen Elizabeth II
city: Kristiansand
country: Norway
facility: Sørlandet sykehus HF Kristiansand
city: Oslo
country: Norway
facility: OUS, Aker
city: Krakow
country: Poland
facility: Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
state: Malopolskie
city: Krakow
country: Poland
facility: UniCardia & UniMedica & UniEstetica
city: Poznan
country: Poland
facility: Centrum Medyczne OMEDICA
city: Pulawy
country: Poland
facility: Velocity Nova Sp. z o.o.
city: Szczecin
country: Poland
facility: Gabinety Lekarskie LabMed
city: Warszawa
country: Poland
facility: DoktorA
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych
city: Castilleja Dela Cuesta Sevilla
country: Spain
facility: Hospital Vithas Sevilla
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Göteborg
country: Sweden
facility: Kärlkirurgen/kärllab
city: Uppsala
country: Sweden
facility: Kärlmottagningen
city: Kaoshiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung City
country: Taiwan
facility: Kuang Tien General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan city
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou Branch
city: Muang
country: Thailand
facility: Srinagarind Hospital
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital-cardio
city: Chiang Mai
country: Thailand
facility: Research Institute for Health Sciences, CMU
city: Nakhon Ratchasima
country: Thailand
facility: Maharat Nakhon Ratchasima Hospital_Ratchasima
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital_Pathumthani
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (1452)
role: STUDY_DIRECTOR
References: