Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

Diabetes Mellitus, Type 2 Clinical Trial

— LEADER®  

Official title:

A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

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
• 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
• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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
United States	Novo Nordisk Investigational Site	Houston	Texas
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 all — Click 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)

External Links

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