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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01179048
Other study ID # EX2211-3748
Secondary ID 2009-012201-19U1
Status Completed
Phase Phase 3
First received
Last updated
Start date August 31, 2010
Est. completion date December 17, 2015

Study information

Verified date July 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


Recruitment information / eligibility

Status Completed
Enrollment 9341
Est. completion date December 17, 2015
Est. primary completion date December 17, 2015
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s) Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
liraglutide
Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
placebo
Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

Locations

Country Name City State
Australia Novo Nordisk Investigational Site Blacktown New South Wales
Australia Novo Nordisk Investigational Site Box Hill Victoria
Australia Novo Nordisk Investigational Site Douglas Queensland
Australia Novo Nordisk Investigational Site Fitzroy Victoria
Australia Novo Nordisk Investigational Site Fremantle Western Australia
Australia Novo Nordisk Investigational Site Herston Queensland
Australia Novo Nordisk Investigational Site Hobart Tasmania
Australia Novo Nordisk Investigational Site Keswick South Australia
Australia Novo Nordisk Investigational Site Meadowbrook Queensland
Australia Novo Nordisk Investigational Site Oaklands Park South Australia
Austria Novo Nordisk Investigational Site Graz
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Belgium Novo Nordisk Investigational Site Edegem
Belgium Novo Nordisk Investigational Site Gent
Belgium Novo Nordisk Investigational Site Leuven
Belgium Novo Nordisk Investigational Site Liège
Brazil Novo Nordisk Investigational Site Aparecida de Goiania Goias
Brazil Novo Nordisk Investigational Site Aracajú
Brazil Novo Nordisk Investigational Site Belém Para
Brazil Novo Nordisk Investigational Site Belo Horizonte
Brazil Novo Nordisk Investigational Site Campinas
Brazil Novo Nordisk Investigational Site Campinas Sao Paulo
Brazil Novo Nordisk Investigational Site Campinas Sao Paulo
Brazil Novo Nordisk Investigational Site Caxias Do Sul Rio Grande Do Sul
Brazil Novo Nordisk Investigational Site Curitiba
Brazil Novo Nordisk Investigational Site Curitiba Parana
Brazil Novo Nordisk Investigational Site Curitiba Parana
Brazil Novo Nordisk Investigational Site Curitiba Parana
Brazil Novo Nordisk Investigational Site Fortaleza Ceara
Brazil Novo Nordisk Investigational Site Fortaleza Ceara
Brazil Novo Nordisk Investigational Site Fortaleza Ceara
Brazil Novo Nordisk Investigational Site Fortaleza
Brazil Novo Nordisk Investigational Site Goiânia
Brazil Novo Nordisk Investigational Site Joinville
Brazil Novo Nordisk Investigational Site Marília
Brazil Novo Nordisk Investigational Site Mogi das Cruzes Sao Paulo
Brazil Novo Nordisk Investigational Site Porto Alegre Rio Grande Do Sul
Brazil Novo Nordisk Investigational Site Porto Alegre
Brazil Novo Nordisk Investigational Site Recife
Brazil Novo Nordisk Investigational Site Rio de Janeiro
Brazil Novo Nordisk Investigational Site Rio de Janeiro
Brazil Novo Nordisk Investigational Site Santos
Brazil Novo Nordisk Investigational Site Sao Paulo
Brazil Novo Nordisk Investigational Site Sao Paulo
Brazil Novo Nordisk Investigational Site São Paulo
Brazil Novo Nordisk Investigational Site São Paulo Sao Paulo
Brazil Novo Nordisk Investigational Site São Paulo Sao Paulo
Brazil Novo Nordisk Investigational Site São Paulo Sao Paulo
Brazil Novo Nordisk Investigational Site São Paulo Sao Paulo
Brazil Novo Nordisk Investigational Site São Paulo Sao Paulo
Brazil Novo Nordisk Investigational Site São Paulo Sao Paulo
Canada Novo Nordisk Investigational Site Cambridge Ontario
Canada Novo Nordisk Investigational Site Cornwall Ontario
Canada Novo Nordisk Investigational Site Edmonton Alberta
Canada Novo Nordisk Investigational Site Halifax Nova Scotia
Canada Novo Nordisk Investigational Site London Ontario
Canada Novo Nordisk Investigational Site London Ontario
Canada Novo Nordisk Investigational Site Mississauga Ontario
Canada Novo Nordisk Investigational Site Montreal Quebec
Canada Novo Nordisk Investigational Site Quebec
Canada Novo Nordisk Investigational Site Quebec
Canada Novo Nordisk Investigational Site Scarborough Ontario
Canada Novo Nordisk Investigational Site Smiths Falls Ontario
Canada Novo Nordisk Investigational Site St.John's Newfoundland and Labrador
Canada Novo Nordisk Investigational Site Thunder Bay Ontario
Canada Novo Nordisk Investigational Site Toronto Ontario
Canada Novo Nordisk Investigational Site Toronto Ontario
Canada Novo Nordisk Investigational Site Vancouver British Columbia
Canada Novo Nordisk Investigational Site Winnipeg Manitoba
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Guangzhou Guangdong
China Novo Nordisk Investigational Site Qingdao Shandong
China Novo Nordisk Investigational Site Shanghai Shanghai
China Novo Nordisk Investigational Site Xiamen Fujian
China Novo Nordisk Investigational Site Zhenjiang Jiangsu
Czechia Novo Nordisk Investigational Site Plzen
Czechia Novo Nordisk Investigational Site Praha
Denmark Novo Nordisk Investigational Site Aalborg
Denmark Novo Nordisk Investigational Site Århus C
Denmark Novo Nordisk Investigational Site Esbjerg
Denmark Novo Nordisk Investigational Site Gentofte
Denmark Novo Nordisk Investigational Site Hvidovre
Denmark Novo Nordisk Investigational Site Odense
Finland Novo Nordisk Investigational Site Kuopio
Finland Novo Nordisk Investigational Site Lahti
Finland Novo Nordisk Investigational Site Oulu
Finland Novo Nordisk Investigational Site Tampere
Finland Novo Nordisk Investigational Site Vantaa
France Novo Nordisk Investigational Site Corbeil Essonnes
France Novo Nordisk Investigational Site Jarny
France Novo Nordisk Investigational Site Nimes
France Novo Nordisk Investigational Site Paris
Germany Novo Nordisk Investigational Site Angermünde/OT Wolletz
Germany Novo Nordisk Investigational Site Aschaffenburg
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Dillingen
Germany Novo Nordisk Investigational Site Dresden
Germany Novo Nordisk Investigational Site Elsterwerda
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Falkensee
Germany Novo Nordisk Investigational Site Gifhorn
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Karlsbad
Germany Novo Nordisk Investigational Site Leipzig
Germany Novo Nordisk Investigational Site Leipzig
Germany Novo Nordisk Investigational Site Ludwigshafen
Germany Novo Nordisk Investigational Site Mannheim
Germany Novo Nordisk Investigational Site München
Germany Novo Nordisk Investigational Site Oldenburg
Germany Novo Nordisk Investigational Site Saint Ingbert-Oberwürzbach
Germany Novo Nordisk Investigational Site Schkeuditz
Germany Novo Nordisk Investigational Site Schweinfurt
Germany Novo Nordisk Investigational Site Ulm
Germany Novo Nordisk Investigational Site Villingen-Schwenningen
Germany Novo Nordisk Investigational Site Wangen
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Crete
Greece Novo Nordisk Investigational Site Thessaloniki
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Chandigarh Punjab
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Guwahati Assam
India Novo Nordisk Investigational Site Hyderabad Andhra Pradesh
India Novo Nordisk Investigational Site Hyderbad Andhra Pradesh
India Novo Nordisk Investigational Site Indore Madhya Pradesh
India Novo Nordisk Investigational Site Karnal Haryana
India Novo Nordisk Investigational Site Kochi Kerala
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Madurai Tamil Nadu
India Novo Nordisk Investigational Site Manipal Karnataka
India Novo Nordisk Investigational Site Mumbai Maharashtra
India Novo Nordisk Investigational Site Thriruvananthapuram
India Novo Nordisk Investigational Site Vellore Tamil Nadu
Ireland Novo Nordisk Investigational Site Dublin
Ireland Novo Nordisk Investigational Site Dublin 9
Israel Novo Nordisk Investigational Site Haifa
Israel Novo Nordisk Investigational Site Haifa
Israel Novo Nordisk Investigational Site Jerusalem
Israel Novo Nordisk Investigational Site Petah-Tikva
Israel Novo Nordisk Investigational Site Tel Hashomer
Italy Novo Nordisk Investigational Site Bologna
Italy Novo Nordisk Investigational Site Catanzaro
Italy Novo Nordisk Investigational Site Chieti
Italy Novo Nordisk Investigational Site Firenze
Italy Novo Nordisk Investigational Site Latina
Italy Novo Nordisk Investigational Site Lucca
Italy Novo Nordisk Investigational Site Milano
Italy Novo Nordisk Investigational Site Padova
Italy Novo Nordisk Investigational Site Palermo
Italy Novo Nordisk Investigational Site Roma
Italy Novo Nordisk Investigational Site Roma
Korea, Republic of Novo Nordisk Investigational Site Goyang
Korea, Republic of Novo Nordisk Investigational Site Seongnam-si
Korea, Republic of Novo Nordisk Investigational Site Seoul
Korea, Republic of Novo Nordisk Investigational Site Seoul
Korea, Republic of Novo Nordisk Investigational Site Seoul
Mexico Novo Nordisk Investigational Site Aguascalientes
Mexico Novo Nordisk Investigational Site Durango
Mexico Novo Nordisk Investigational Site Durango
Mexico Novo Nordisk Investigational Site Guadalajara Jalisco
Mexico Novo Nordisk Investigational Site Guadalajara Jalisco
Mexico Novo Nordisk Investigational Site Monterrey
Mexico Novo Nordisk Investigational Site San Luis Potosi
Mexico Novo Nordisk Investigational Site Tijuana Baja California Norte
Netherlands Novo Nordisk Investigational Site Amsterdam
Netherlands Novo Nordisk Investigational Site Eindhoven
Netherlands Novo Nordisk Investigational Site Etten-Leur
Netherlands Novo Nordisk Investigational Site Goes
Netherlands Novo Nordisk Investigational Site Groningen
Netherlands Novo Nordisk Investigational Site Hoogeveen
Netherlands Novo Nordisk Investigational Site Maastricht
Netherlands Novo Nordisk Investigational Site Nijmegen
Netherlands Novo Nordisk Investigational Site Utrecht
Norway Novo Nordisk Investigational Site Oslo
Norway Novo Nordisk Investigational Site Oslo
Norway Novo Nordisk Investigational Site Stavanger
Norway Novo Nordisk Investigational Site Tønsberg
Norway Novo Nordisk Investigational Site Trondheim
Poland Novo Nordisk Investigational Site Bialystok
Poland Novo Nordisk Investigational Site Bydgoszcz
Poland Novo Nordisk Investigational Site Katowice
Poland Novo Nordisk Investigational Site Krakow
Poland Novo Nordisk Investigational Site Krakow
Poland Novo Nordisk Investigational Site Krakow
Poland Novo Nordisk Investigational Site Lodz
Poland Novo Nordisk Investigational Site Poznan
Poland Novo Nordisk Investigational Site Pulawy
Poland Novo Nordisk Investigational Site Ruda Slaska
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Wroclaw
Puerto Rico Novo Nordisk Investigational Site Bayamon
Puerto Rico Novo Nordisk Investigational Site Caguas
Romania Novo Nordisk Investigational Site Bacau
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Constanta
Romania Novo Nordisk Investigational Site Craiova Dolj
Romania Novo Nordisk Investigational Site Deva
Romania Novo Nordisk Investigational Site Iasi
Romania Novo Nordisk Investigational Site Satu Mare
Romania Novo Nordisk Investigational Site Sibiu
Romania Novo Nordisk Investigational Site Targu Mures Mures
Romania Novo Nordisk Investigational Site Timisoara Timis
Russian Federation Novo Nordisk Investigational Site Arkhangelsk
Russian Federation Novo Nordisk Investigational Site Arkhangelsk
Russian Federation Novo Nordisk Investigational Site Barnaul
Russian Federation Novo Nordisk Investigational Site Kazan
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Nizhniy Novgorod
Russian Federation Novo Nordisk Investigational Site Penza
Russian Federation Novo Nordisk Investigational Site Saratov
Russian Federation Novo Nordisk Investigational Site Smolensk
Russian Federation Novo Nordisk Investigational Site Tumen
Russian Federation Novo Nordisk Investigational Site Yaroslavl
Serbia Novo Nordisk Investigational Site Belgrade
South Africa Novo Nordisk Investigational Site Alberton
South Africa Novo Nordisk Investigational Site Bloemfontein Free State
South Africa Novo Nordisk Investigational Site Cape Town
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Lenasia Gauteng
South Africa Novo Nordisk Investigational Site Midrand Gauteng
South Africa Novo Nordisk Investigational Site Pretoria Gauteng
South Africa Novo Nordisk Investigational Site Pretoria Gauteng
South Africa Novo Nordisk Investigational Site Pretoria Gauteng
South Africa Novo Nordisk Investigational Site Somerset West Western Cape
South Africa Novo Nordisk Investigational Site Tongaat KwaZulu-Natal
Spain Novo Nordisk Investigational Site Almería
Spain Novo Nordisk Investigational Site Barcelona
Spain Novo Nordisk Investigational Site La Coruña
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Mora De Ebre
Spain Novo Nordisk Investigational Site Mostoles - Madrid -
Spain Novo Nordisk Investigational Site Palma de Mallorca
Spain Novo Nordisk Investigational Site Pozuelo de Alarcon
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Valladolid
Sweden Novo Nordisk Investigational Site Göteborg
Sweden Novo Nordisk Investigational Site Malmö
Sweden Novo Nordisk Investigational Site Örebro
Sweden Novo Nordisk Investigational Site Stockholm
Sweden Novo Nordisk Investigational Site Stockholm
Sweden Novo Nordisk Investigational Site Stockholm
Taiwan Novo Nordisk Investigational Site Changhua City
Taiwan Novo Nordisk Investigational Site Kaoshiung
Taiwan Novo Nordisk Investigational Site Tainan city
Taiwan Novo Nordisk Investigational Site Taoyuan
Turkey Novo Nordisk Investigational Site Ankara
Turkey Novo Nordisk Investigational Site Ankara
Turkey Novo Nordisk Investigational Site Antalya
Turkey Novo Nordisk Investigational Site Bursa
Turkey Novo Nordisk Investigational Site Gaziantep
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Izmir
Turkey Novo Nordisk Investigational Site Izmir
Turkey Novo Nordisk Investigational Site Kayseri
United Arab Emirates Novo Nordisk Investigational Site Dubai
United Arab Emirates Novo Nordisk Investigational Site Dubai
United Kingdom Novo Nordisk Investigational Site Aberdeen
United Kingdom Novo Nordisk Investigational Site Birmingham
United Kingdom Novo Nordisk Investigational Site Bristol
United Kingdom Novo Nordisk Investigational Site Coventry
United Kingdom Novo Nordisk Investigational Site Devon
United Kingdom Novo Nordisk Investigational Site Dundee
United Kingdom Novo Nordisk Investigational Site Edinburgh
United Kingdom Novo Nordisk Investigational Site Glasgow
United Kingdom Novo Nordisk Investigational Site Guildford
United Kingdom Novo Nordisk Investigational Site Hull
United Kingdom Novo Nordisk Investigational Site Livington
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Manchester
United Kingdom Novo Nordisk Investigational Site Norwich
United Kingdom Novo Nordisk Investigational Site Nuneaton
United Kingdom Novo Nordisk Investigational Site Plymouth
United Kingdom Novo Nordisk Investigational Site St Helens
United Kingdom Novo Nordisk Investigational Site Swansea
United Kingdom Novo Nordisk Investigational Site Torquay
United Kingdom Novo Nordisk Investigational Site West Midlands
United States Novo Nordisk Investigational Site Alabaster Alabama
United States Novo Nordisk Investigational Site Albany New York
United States Novo Nordisk Investigational Site Altoona Pennsylvania
United States Novo Nordisk Investigational Site Anaheim California
United States Novo Nordisk Investigational Site Arlington Texas
United States Novo Nordisk Investigational Site Asheville North Carolina
United States Novo Nordisk Investigational Site Aurora Colorado
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Bartlett Tennessee
United States Novo Nordisk Investigational Site Beaver Pennsylvania
United States Novo Nordisk Investigational Site Birmingham Alabama
United States Novo Nordisk Investigational Site Birmingham Alabama
United States Novo Nordisk Investigational Site Bloomfield Hills Michigan
United States Novo Nordisk Investigational Site Bradenton Florida
United States Novo Nordisk Investigational Site Buffalo New York
United States Novo Nordisk Investigational Site Burlington North Carolina
United States Novo Nordisk Investigational Site Cadiz Ohio
United States Novo Nordisk Investigational Site Cerritos California
United States Novo Nordisk Investigational Site Chapel Hill North Carolina
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Clearwater Florida
United States Novo Nordisk Investigational Site Cleveland Ohio
United States Novo Nordisk Investigational Site Columbia South Carolina
United States Novo Nordisk Investigational Site Corpus Christi Texas
United States Novo Nordisk Investigational Site Crystal Lake Illinois
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dearborn Michigan
United States Novo Nordisk Investigational Site DeLand Florida
United States Novo Nordisk Investigational Site Denver Colorado
United States Novo Nordisk Investigational Site Escondido California
United States Novo Nordisk Investigational Site Fort Lauderdale Florida
United States Novo Nordisk Investigational Site Fresno California
United States Novo Nordisk Investigational Site Great Falls Montana
United States Novo Nordisk Investigational Site Greensboro North Carolina
United States Novo Nordisk Investigational Site Greenville North Carolina
United States Novo Nordisk Investigational Site Greenville South Carolina
United States Novo Nordisk Investigational Site Greer South Carolina
United States Novo Nordisk Investigational Site Hatfield Pennsylvania
United States Novo Nordisk Investigational Site Houston Texas
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United States Novo Nordisk Investigational Site Huntsville Alabama
United States Novo Nordisk Investigational Site Indianapolis Indiana
United States Novo Nordisk Investigational Site Interlochen Michigan
United States Novo Nordisk Investigational Site Kingsport Tennessee
United States Novo Nordisk Investigational Site Kissimmee Florida
United States Novo Nordisk Investigational Site Lawrenceville Georgia
United States Novo Nordisk Investigational Site Lebanon New Hampshire
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Little Rock Arkansas
United States Novo Nordisk Investigational Site Little Rock Arkansas
United States Novo Nordisk Investigational Site Longview Texas
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Los Banos California
United States Novo Nordisk Investigational Site Louisville Kentucky
United States Novo Nordisk Investigational Site Louisville Kentucky
United States Novo Nordisk Investigational Site Lubbock Texas
United States Novo Nordisk Investigational Site Madison Wisconsin
United States Novo Nordisk Investigational Site Marion Ohio
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Metairie Louisiana
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site Michigan City Indiana
United States Novo Nordisk Investigational Site Middleburg Heights Ohio
United States Novo Nordisk Investigational Site Mine Hill New Jersey
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Mission Hills California
United States Novo Nordisk Investigational Site Mobile Alabama
United States Novo Nordisk Investigational Site Monroe Louisiana
United States Novo Nordisk Investigational Site Monroe North Carolina
United States Novo Nordisk Investigational Site Montclair California
United States Novo Nordisk Investigational Site Mooresville North Carolina
United States Novo Nordisk Investigational Site Morehead City North Carolina
United States Novo Nordisk Investigational Site Murrells Inlet South Carolina
United States Novo Nordisk Investigational Site Myrtle Beach South Carolina
United States Novo Nordisk Investigational Site Nashua New Hampshire
United States Novo Nordisk Investigational Site Nashville Tennessee
United States Novo Nordisk Investigational Site Natchitoches Louisiana
United States Novo Nordisk Investigational Site Neptune New Jersey
United States Novo Nordisk Investigational Site New Orleans Louisiana
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site Newark Delaware
United States Novo Nordisk Investigational Site Odessa Texas
United States Novo Nordisk Investigational Site Oklahoma City Oklahoma
United States Novo Nordisk Investigational Site Oklahoma City Oklahoma
United States Novo Nordisk Investigational Site Omaha Nebraska
United States Novo Nordisk Investigational Site Orlando Florida
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Roswell Georgia
United States Novo Nordisk Investigational Site Saint Louis Missouri
United States Novo Nordisk Investigational Site Saint Petersburg Florida
United States Novo Nordisk Investigational Site Salt Lake City Utah
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site Schertz Texas
United States Novo Nordisk Investigational Site Smithtown New York
United States Novo Nordisk Investigational Site South Burlington Vermont
United States Novo Nordisk Investigational Site Spokane Washington
United States Novo Nordisk Investigational Site Springfield Missouri
United States Novo Nordisk Investigational Site Syracuse New York
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Tempe Arizona
United States Novo Nordisk Investigational Site Tomball Texas
United States Novo Nordisk Investigational Site Troy Michigan
United States Novo Nordisk Investigational Site Tustin California
United States Novo Nordisk Investigational Site Uniontown Pennsylvania
United States Novo Nordisk Investigational Site Walnut Creek California
United States Novo Nordisk Investigational Site Watsonville California
United States Novo Nordisk Investigational Site West Des Moines Iowa
United States Novo Nordisk Investigational Site West Palm Beach Florida
United States Novo Nordisk Investigational Site Westfield New York
United States Novo Nordisk Investigational Site Whiteville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  India,  Ireland,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  United Arab Emirates,  United Kingdom, 

References & Publications (25)

Daniels GH, Hegedüs L, Marso SP, Nauck MA, Zinman B, Bergenstal RM, Mann JF, Derving Karsbøl J, Moses AC, Buse JB, Tuttle RM; LEADER Trial Investigators. LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect — View Citation

Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L, Kaltoft MS, Stellfeld M, Tornøe K, Pratley RE; LEADER Publication Committee on behalf of the LEADER Trial Investigators. The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Compl — View Citation

Gilbert MP, Bain SC, Franek E, Jodar-Gimeno E, Nauck MA, Pratley R, Réa RR, Kerr Saraiva JF, Rasmussen S, Tornøe K, von Scholten BJ, Buse JB; and the LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardio — View Citation

Hegedüs L, Sherman SI, Tuttle RM, von Scholten BJ, Rasmussen S, Karsbøl JD, Daniels GH; LEADER Publication Committee on behalf of the LEADER Trial Investigators. No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in R — View Citation

Hinton W, Feher M, Munro N, Walker M, de Lusignan S. Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network. Diabetes Obes Metab. 2019 Jul;21(7):1661-1667. doi: 10.1111/dom.13710. Epub 2019 Apr 11. — View Citation

Mann JFE, Fonseca V, Mosenzon O, Raz I, Goldman B, Idorn T, von Scholten BJ, Poulter NR. Effects of Liraglutide Versus Placebo on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease. Circulation. 2018 Dec 18;138(25): — View Citation

Mann JFE, Ørsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornøe K, Zinman B, Buse JB; LEADER Steering Committee and Investigators. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Aug 31;377(9):839-848. doi: 10.1056/N — View Citation

Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovas — View Citation

Marso SP, Nauck MA, Monk Fries T, Rasmussen S, Treppendahl MB, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Myocardial Infarction Subtypes in Patients With Type 2 Diabetes Mellitus and the Effect of Liraglutide Therap — View Citation

Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results — View Citation

Masmiquel L, Leiter LA, Vidal J, Bain S, Petrie J, Franek E, Raz I, Comlekci A, Jacob S, van Gaal L, Baeres FM, Marso SP, Eriksson M; LEADER investigators. LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients wit — View Citation

Nauck MA, Buse JB, Mann JFE, Pocock S, Bosch-Traberg H, Frimer-Larsen H, Ye Q, Gray A; LEADER Publication Committee for the LEADER Trial Investigators. Health-related quality of life in people with type 2 diabetes participating in the LEADER trial. Diabet — View Citation

Nauck MA, Jensen TJ, Rosenkilde C, Calanna S, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial. Diabe — View Citation

Nauck MA, Tornøe K, Rasmussen S, Treppendahl MB, Marso SP; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Cardiovascular outcomes in patients who experienced a myocardial infarction while treated with liraglutide versus placebo — View Citation

Petrie JR, Marso SP, Bain SC, Franek E, Jacob S, Masmiquel L, Leiter LA, Haluzik M, Satman I, Omar M, Shestakova M, Van Gaal L, Mann JF, Baeres FM, Zinman B, Poulter NR; LEADER investigators. LEADER-4: blood pressure control in patients with type 2 diabet — View Citation

Rutten GE, Tack CJ, Pieber TR, Comlekci A, Ørsted DD, Baeres FM, Marso SP, Buse JB; LEADER Investigators. LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ. Diabetol Metab Syndr. 2016 Jun 2;8:37. do — View Citation

Satman I, R Rea R, Eriksson M, Mosenzon O, Pratley R, M Baeres F, D Ørsted D, F Mann J; LEADER Trial Investigators. LEADER-6: Baseline renal function and associated factors in a high cardiovascular risk type 2 diabetes population. J Diabetes Complications — View Citation

Steinberg WM, Buse JB, Ghorbani MLM, Ørsted DD, Nauck MA; LEADER Steering Committee; LEADER Trial Investigators. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial. Dia — View Citation

Steinberg WM, Nauck MA, Zinman B, Daniels GH, Bergenstal RM, Mann JF, Steen Ravn L, Moses AC, Stockner M, Baeres FM, Marso SP, Buse JB; LEADER Trial investigators. LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from — View Citation

Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2. — View Citation

Verma S, Bhatt DL, Bain SC, Buse JB, Mann JFE, Marso SP, Nauck MA, Poulter NR, Pratley RE, Zinman B, Michelsen MM, Monk Fries T, Rasmussen S, Leiter LA; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Car — View Citation

Verma S, Leiter LA, Mazer CD, Bain SC, Buse J, Marso S, Nauck M, Zinman B, Bosch-Traberg H, Rasmussen S, Michelsen MM, Bhatt DL. Liraglutide Reduces Cardiovascular Events and Mortality in Type 2 Diabetes Mellitus Independently of Baseline Low-Density Lipo — View Citation

Verma S, Poulter NR, Bhatt DL, Bain SC, Buse JB, Leiter LA, Nauck MA, Pratley RE, Zinman B, Ørsted DD, Monk Fries T, Rasmussen S, Marso SP. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus With or Without History — View Citation

Zinman B, Marso SP, Christiansen E, Calanna S, Rasmussen S, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Hypoglycemia, Cardiovascular Outcomes, and Death: The LEADER Experience. Diabetes Care. 2018 Aug;41(8):1783-1791 — View Citation

Zinman B, Nauck MA, Bosch-Traberg H, Frimer-Larsen H, Ørsted DD, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Liraglutide and Glycaemic Outcomes in the LEADER Trial. Diabetes Ther. 2018 Dec;9(6):2383-2392. doi: 10.100 — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented. from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure. Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented. from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary Time From Randomisation to All Cause Death Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented. from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented. from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary Time From Randomisation to First Occurrence of a Composite Microvascular Outcome Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following:
new onset of persistent macroalbuminuria
persistent doubling of serum creatinine
need for continuous renal replacement therapy
death due to renal disease
need for retinal photocoagulation or treatment with intravitreal agents
vitreous haemorrhage
diabetes-related blindness
The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately. Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented. from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
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