Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER®)

July 3, 2019 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9341

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Novo Nordisk INvestigational Site
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Novo Nordisk INvestigational Site
      • Herston, Queensland, Australia, 4029
        • Novo Nordisk INvestigational Site
      • Meadowbrook, Queensland, Australia, 4131
        • Novo Nordisk INvestigational Site
    • South Australia
      • Keswick, South Australia, Australia, 5035
        • Novo Nordisk INvestigational Site
      • Oaklands Park, South Australia, Australia, 5046
        • Novo Nordisk INvestigational Site
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Novo Nordisk INvestigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Novo Nordisk INvestigational Site
      • Fitzroy, Victoria, Australia, 3065
        • Novo Nordisk INvestigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Novo Nordisk INvestigational Site
      • Graz, Austria, 8036
        • Novo Nordisk INvestigational Site
      • Wien, Austria, 1090
        • Novo Nordisk INvestigational Site
      • Wien, Austria, 1130
        • Novo Nordisk INvestigational Site
      • Wien, Austria, 1030
        • Novo Nordisk INvestigational Site
      • Wien, Austria, 1140
        • Novo Nordisk INvestigational Site
      • Edegem, Belgium, 2650
        • Novo Nordisk INvestigational Site
      • Gent, Belgium, 9000
        • Novo Nordisk INvestigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk INvestigational Site
      • Liège, Belgium, 4000
        • Novo Nordisk INvestigational Site
      • Aracajú, Brazil, 49020-270
        • Novo Nordisk INvestigational Site
      • Belo Horizonte, Brazil, 30150-221
        • Novo Nordisk INvestigational Site
      • Campinas, Brazil, 13084-971
        • Novo Nordisk INvestigational Site
      • Curitiba, Brazil, 80420-011
        • Novo Nordisk INvestigational Site
      • Fortaleza, Brazil, 60430-350
        • Novo Nordisk INvestigational Site
      • Goiânia, Brazil, 74110-120
        • Novo Nordisk INvestigational Site
      • Joinville, Brazil, 05001-100
        • Novo Nordisk INvestigational Site
      • Marília, Brazil, 17519-000
        • Novo Nordisk INvestigational Site
      • Porto Alegre, Brazil, 90035-170
        • Novo Nordisk INvestigational Site
      • Recife, Brazil, 52020-010
        • Novo Nordisk INvestigational Site
      • Rio de Janeiro, Brazil, 20211-340
        • Novo Nordisk INvestigational Site
      • Rio de Janeiro, Brazil, 20551-030
        • Novo Nordisk INvestigational Site
      • Santos, Brazil, 11045-904
        • Novo Nordisk INvestigational Site
      • Sao Paulo, Brazil, 01323-001
        • Novo Nordisk INvestigational Site
      • Sao Paulo, Brazil, 04011-030
        • Novo Nordisk INvestigational Site
      • São Paulo, Brazil, 05403-000
        • Novo Nordisk INvestigational Site
    • Ceara
      • Fortaleza, Ceara, Brazil, 60192-340
        • Novo Nordisk INvestigational Site
      • Fortaleza, Ceara, Brazil, 60115-282
        • Novo Nordisk INvestigational Site
      • Fortaleza, Ceara, Brazil, 60170-001
        • Novo Nordisk INvestigational Site
    • Goias
      • Aparecida de Goiania, Goias, Brazil, 74935-530
        • Novo Nordisk INvestigational Site
    • Para
      • Belém, Para, Brazil, 66073-000
        • Novo Nordisk INvestigational Site
    • Parana
      • Curitiba, Parana, Brazil, 80030-110
        • Novo Nordisk INvestigational Site
      • Curitiba, Parana, Brazil, 80810-040
        • Novo Nordisk INvestigational Site
      • Curitiba, Parana, Brazil, 80010-030
        • Novo Nordisk INvestigational Site
    • Rio Grande Do Sul
      • Caxias Do Sul, Rio Grande Do Sul, Brazil, 95070-560
        • Novo Nordisk INvestigational Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
        • Novo Nordisk INvestigational Site
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13059-740
        • Novo Nordisk INvestigational Site
      • Campinas, Sao Paulo, Brazil, 13073-350
        • Novo Nordisk INvestigational Site
      • Mogi das Cruzes, Sao Paulo, Brazil, 08780-090
        • Novo Nordisk INvestigational Site
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Novo Nordisk INvestigational Site
      • São Paulo, Sao Paulo, Brazil, 01223-001
        • Novo Nordisk INvestigational Site
      • São Paulo, Sao Paulo, Brazil, 01228-000
        • Novo Nordisk INvestigational Site
      • São Paulo, Sao Paulo, Brazil, 01228-200
        • Novo Nordisk INvestigational Site
      • São Paulo, Sao Paulo, Brazil, 04012-909
        • Novo Nordisk INvestigational Site
      • São Paulo, Sao Paulo, Brazil, 04020-041
        • Novo Nordisk INvestigational Site
      • Quebec, Canada, G1V 4G2
        • Novo Nordisk INvestigational Site
      • Quebec, Canada, G1V 4G5
        • Novo Nordisk INvestigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk INvestigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3X8
        • Novo Nordisk INvestigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk INvestigational Site
    • Newfoundland and Labrador
      • St.John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Novo Nordisk INvestigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Novo Nordisk INvestigational Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7L6
        • Novo Nordisk INvestigational Site
      • Cornwall, Ontario, Canada, K6H 4M4
        • Novo Nordisk INvestigational Site
      • London, Ontario, Canada, N6G 2M1
        • Novo Nordisk INvestigational Site
      • London, Ontario, Canada, N6A 4V2
        • Novo Nordisk INvestigational Site
      • Mississauga, Ontario, Canada, L5M 2V8
        • Novo Nordisk INvestigational Site
      • Scarborough, Ontario, Canada, M1E 5E9
        • Novo Nordisk INvestigational Site
      • Smiths Falls, Ontario, Canada, K7A 4W8
        • Novo Nordisk INvestigational Site
      • Thunder Bay, Ontario, Canada, P7A 4V7
        • Novo Nordisk INvestigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novo Nordisk INvestigational Site
      • Toronto, Ontario, Canada, M5T 3L9
        • Novo Nordisk INvestigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Novo Nordisk INvestigational Site
    • Beijing
      • Beijing, Beijing, China, 100044
        • Novo Nordisk INvestigational Site
      • Beijing, Beijing, China, 100730
        • Novo Nordisk INvestigational Site
      • Beijing, Beijing, China, 100853
        • Novo Nordisk INvestigational Site
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Novo Nordisk INvestigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Novo Nordisk INvestigational Site
    • Jiangsu
      • Zhenjiang, Jiangsu, China, 212001
        • Novo Nordisk INvestigational Site
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Novo Nordisk INvestigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Novo Nordisk INvestigational Site
      • Plzen, Czechia, 304 60
        • Novo Nordisk INvestigational Site
      • Praha, Czechia, 128 08
        • Novo Nordisk INvestigational Site
      • Aalborg, Denmark, 9100
        • Novo Nordisk INvestigational Site
      • Esbjerg, Denmark, 6700
        • Novo Nordisk INvestigational Site
      • Gentofte, Denmark, 2820
        • Novo Nordisk INvestigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk INvestigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk INvestigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk INvestigational Site
      • Kuopio, Finland, 70210
        • Novo Nordisk INvestigational Site
      • Lahti, Finland, 15110
        • Novo Nordisk INvestigational Site
      • Oulu, Finland, 90220
        • Novo Nordisk INvestigational Site
      • Tampere, Finland, 33520
        • Novo Nordisk INvestigational Site
      • Vantaa, Finland, FIN-01600
        • Novo Nordisk INvestigational Site
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk INvestigational Site
      • Jarny, France, 54800
        • Novo Nordisk INvestigational Site
      • Nimes, France, 30006
        • Novo Nordisk INvestigational Site
      • Paris, France, 75877
        • Novo Nordisk INvestigational Site
      • Angermünde/OT Wolletz, Germany, 16278
        • Novo Nordisk INvestigational Site
      • Aschaffenburg, Germany, 63739
        • Novo Nordisk INvestigational Site
      • Berlin, Germany, 12163
        • Novo Nordisk INvestigational Site
      • Berlin, Germany, 13055
        • Novo Nordisk INvestigational Site
      • Dillingen, Germany, 89407
        • Novo Nordisk INvestigational Site
      • Dresden, Germany, 01219
        • Novo Nordisk INvestigational Site
      • Elsterwerda, Germany, 04910
        • Novo Nordisk INvestigational Site
      • Essen, Germany, 45219
        • Novo Nordisk INvestigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk INvestigational Site
      • Gifhorn, Germany, 38518
        • Novo Nordisk INvestigational Site
      • Hamburg, Germany, 22587
        • Novo Nordisk INvestigational Site
      • Karlsbad, Germany, 76307
        • Novo Nordisk INvestigational Site
      • Leipzig, Germany, 04103
        • Novo Nordisk INvestigational Site
      • Leipzig, Germany, 04275
        • Novo Nordisk INvestigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk INvestigational Site
      • Mannheim, Germany, 68163
        • Novo Nordisk INvestigational Site
      • München, Germany, 80336
        • Novo Nordisk INvestigational Site
      • Oldenburg, Germany, 23758
        • Novo Nordisk INvestigational Site
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Novo Nordisk INvestigational Site
      • Schkeuditz, Germany, 04435
        • Novo Nordisk INvestigational Site
      • Schweinfurt, Germany, 97421
        • Novo Nordisk INvestigational Site
      • Ulm, Germany, 89081
        • Novo Nordisk INvestigational Site
      • Villingen-Schwenningen, Germany, 78048
        • Novo Nordisk INvestigational Site
      • Wangen, Germany, 88239
        • Novo Nordisk INvestigational Site
      • Athens, Greece, GR-11527
        • Novo Nordisk INvestigational Site
      • Athens, Greece, GR-10552
        • Novo Nordisk INvestigational Site
      • Crete, Greece, 71001
        • Novo Nordisk INvestigational Site
      • Thessaloniki, Greece, GR-57001
        • Novo Nordisk INvestigational Site
      • Thriruvananthapuram, India, 695 032
        • Novo Nordisk INvestigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Novo Nordisk INvestigational Site
      • Hyderbad, Andhra Pradesh, India, 500 012
        • Novo Nordisk INvestigational Site
    • Assam
      • Guwahati, Assam, India, 781007
        • Novo Nordisk INvestigational Site
    • Haryana
      • Karnal, Haryana, India, 132001
        • Novo Nordisk INvestigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Novo Nordisk INvestigational Site
      • Bangalore, Karnataka, India, 560052
        • Novo Nordisk INvestigational Site
      • Bangalore, Karnataka, India, 560 003
        • Novo Nordisk INvestigational Site
      • Manipal, Karnataka, India, 576104
        • Novo Nordisk INvestigational Site
    • Kerala
      • Kochi, Kerala, India, 682041
        • Novo Nordisk INvestigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Novo Nordisk INvestigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Novo Nordisk INvestigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Novo Nordisk INvestigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk INvestigational Site
      • Chennai, Tamil Nadu, India, 600029
        • Novo Nordisk INvestigational Site
      • Madurai, Tamil Nadu, India, 625 020
        • Novo Nordisk INvestigational Site
      • Vellore, Tamil Nadu, India, 632004
        • Novo Nordisk INvestigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Novo Nordisk INvestigational Site
      • Dublin, Ireland, DUBLIN 4
        • Novo Nordisk INvestigational Site
      • Dublin 9, Ireland
        • Novo Nordisk INvestigational Site
      • Haifa, Israel, 31096
        • Novo Nordisk INvestigational Site
      • Haifa, Israel, 35152
        • Novo Nordisk INvestigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk INvestigational Site
      • Petah-Tikva, Israel, 49372
        • Novo Nordisk INvestigational Site
      • Tel Hashomer, Israel, 52621
        • Novo Nordisk INvestigational Site
      • Bologna, Italy, 40138
        • Novo Nordisk INvestigational Site
      • Catanzaro, Italy, 88100
        • Novo Nordisk INvestigational Site
      • Chieti, Italy, 66100
        • Novo Nordisk INvestigational Site
      • Firenze, Italy, 50141
        • Novo Nordisk INvestigational Site
      • Latina, Italy, 04100
        • Novo Nordisk INvestigational Site
      • Lucca, Italy, 55100
        • Novo Nordisk INvestigational Site
      • Milano, Italy, 20132
        • Novo Nordisk INvestigational Site
      • Padova, Italy, 35128
        • Novo Nordisk INvestigational Site
      • Palermo, Italy, 90127
        • Novo Nordisk INvestigational Site
      • Roma, Italy, 00161
        • Novo Nordisk INvestigational Site
      • Roma, Italy, 00133
        • Novo Nordisk INvestigational Site
      • Goyang, Korea, Republic of, 410-719
        • Novo Nordisk INvestigational Site
      • Seongnam-si, Korea, Republic of, 463-707
        • Novo Nordisk INvestigational Site
      • Seoul, Korea, Republic of, 139-827
        • Novo Nordisk INvestigational Site
      • Seoul, Korea, Republic of, 02447
        • Novo Nordisk INvestigational Site
      • Seoul, Korea, Republic of, 137-701
        • Novo Nordisk INvestigational Site
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk INvestigational Site
      • Durango, Mexico, 34000
        • Novo Nordisk INvestigational Site
      • Durango, Mexico, 34080
        • Novo Nordisk INvestigational Site
      • Monterrey, Mexico, 64460
        • Novo Nordisk INvestigational Site
      • San Luis Potosi, Mexico, 78200
        • Novo Nordisk INvestigational Site
    • Baja California Norte
      • Tijuana, Baja California Norte, Mexico, 22010
        • Novo Nordisk INvestigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Novo Nordisk INvestigational Site
      • Guadalajara, Jalisco, Mexico, 44650
        • Novo Nordisk INvestigational Site
      • Amsterdam, Netherlands, 1066 EC
        • Novo Nordisk INvestigational Site
      • Eindhoven, Netherlands, 5631 BM
        • Novo Nordisk INvestigational Site
      • Etten-Leur, Netherlands, 4872 LP
        • Novo Nordisk INvestigational Site
      • Goes, Netherlands, 4461 LT
        • Novo Nordisk INvestigational Site
      • Groningen, Netherlands, 9728 NT
        • Novo Nordisk INvestigational Site
      • Hoogeveen, Netherlands, 7909 AA
        • Novo Nordisk INvestigational Site
      • Maastricht, Netherlands, 6229 HX
        • Novo Nordisk INvestigational Site
      • Nijmegen, Netherlands, 6525 GA
        • Novo Nordisk INvestigational Site
      • Utrecht, Netherlands, 3584 CX
        • Novo Nordisk INvestigational Site
      • Oslo, Norway, 0586
        • Novo Nordisk INvestigational Site
      • Oslo, Norway, 0407
        • Novo Nordisk INvestigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk INvestigational Site
      • Trondheim, Norway, 7030
        • Novo Nordisk INvestigational Site
      • Tønsberg, Norway, 3117
        • Novo Nordisk INvestigational Site
      • Bialystok, Poland, 15-435
        • Novo Nordisk INvestigational Site
      • Bydgoszcz, Poland, 85-822
        • Novo Nordisk INvestigational Site
      • Katowice, Poland, 40-084
        • Novo Nordisk INvestigational Site
      • Krakow, Poland, 31-501
        • Novo Nordisk INvestigational Site
      • Krakow, Poland, 31-271
        • Novo Nordisk INvestigational Site
      • Krakow, Poland, 31-261
        • Novo Nordisk INvestigational Site
      • Lodz, Poland, 93-338
        • Novo Nordisk INvestigational Site
      • Poznan, Poland, 60-569
        • Novo Nordisk INvestigational Site
      • Pulawy, Poland, 24-100
        • Novo Nordisk INvestigational Site
      • Ruda Slaska, Poland, 41-709
        • Novo Nordisk INvestigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk INvestigational Site
      • Warszawa, Poland, 01-192
        • Novo Nordisk INvestigational Site
      • Wroclaw, Poland, 50-381
        • Novo Nordisk INvestigational Site
      • Bayamon, Puerto Rico, 00961
        • Novo Nordisk INvestigational Site
      • Caguas, Puerto Rico, 00725
        • Novo Nordisk INvestigational Site
      • Bacau, Romania, 600114
        • Novo Nordisk INvestigational Site
      • Bucharest, Romania, 020475
        • Novo Nordisk INvestigational Site
      • Constanta, Romania, 900591
        • Novo Nordisk INvestigational Site
      • Deva, Romania, 330084
        • Novo Nordisk INvestigational Site
      • Iasi, Romania, 700547
        • Novo Nordisk INvestigational Site
      • Satu Mare, Romania, 440055
        • Novo Nordisk INvestigational Site
      • Sibiu, Romania, 550245
        • Novo Nordisk INvestigational Site
    • Dolj
      • Craiova, Dolj, Romania, 200642
        • Novo Nordisk INvestigational Site
    • Mures
      • Targu Mures, Mures, Romania, 540098
        • Novo Nordisk INvestigational Site
    • Timis
      • Timisoara, Timis, Romania, 300736
        • Novo Nordisk INvestigational Site
      • Arkhangelsk, Russian Federation, 163045
        • Novo Nordisk INvestigational Site
      • Arkhangelsk, Russian Federation, 163001
        • Novo Nordisk INvestigational Site
      • Barnaul, Russian Federation, 656045
        • Novo Nordisk INvestigational Site
      • Kazan, Russian Federation, 420043
        • Novo Nordisk INvestigational Site
      • Moscow, Russian Federation, 119435
        • Novo Nordisk INvestigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk INvestigational Site
      • Moscow, Russian Federation, 125367
        • Novo Nordisk INvestigational Site
      • Moscow, Russian Federation, 127486
        • Novo Nordisk INvestigational Site
      • Nizhniy Novgorod, Russian Federation, 603126
        • Novo Nordisk INvestigational Site
      • Penza, Russian Federation, 440026
        • Novo Nordisk INvestigational Site
      • Saratov, Russian Federation, 410053
        • Novo Nordisk INvestigational Site
      • Smolensk, Russian Federation, 214019
        • Novo Nordisk INvestigational Site
      • Tumen, Russian Federation, 625023
        • Novo Nordisk INvestigational Site
      • Yaroslavl, Russian Federation, 150062
        • Novo Nordisk INvestigational Site
      • Belgrade, Serbia, 11000
        • Novo Nordisk INvestigational Site
      • Alberton, South Africa, 1449
        • Novo Nordisk INvestigational Site
      • Cape Town, South Africa, 7530
        • Novo Nordisk INvestigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk INvestigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Novo Nordisk INvestigational Site
      • Johannesburg, Gauteng, South Africa, 2013
        • Novo Nordisk INvestigational Site
      • Lenasia, Gauteng, South Africa, 1827
        • Novo Nordisk INvestigational Site
      • Midrand, Gauteng, South Africa, 1685
        • Novo Nordisk INvestigational Site
      • Pretoria, Gauteng, South Africa, 0181
        • Novo Nordisk INvestigational Site
      • Pretoria, Gauteng, South Africa, 0083
        • Novo Nordisk INvestigational Site
      • Pretoria, Gauteng, South Africa, 0001
        • Novo Nordisk INvestigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4126
        • Novo Nordisk INvestigational Site
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk INvestigational Site
      • Durban, KwaZulu-Natal, South Africa, 4320
        • Novo Nordisk INvestigational Site
      • Tongaat, KwaZulu-Natal, South Africa, 4400
        • Novo Nordisk INvestigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Novo Nordisk INvestigational Site
      • Somerset West, Western Cape, South Africa, 7130
        • Novo Nordisk INvestigational Site
      • Almería, Spain, 04001
        • Novo Nordisk INvestigational Site
      • Barcelona, Spain, 08036
        • Novo Nordisk INvestigational Site
      • La Coruña, Spain, 15006
        • Novo Nordisk INvestigational Site
      • Madrid, Spain, 28040
        • Novo Nordisk INvestigational Site
      • Mora De Ebre, Spain, 43740
        • Novo Nordisk INvestigational Site
      • Mostoles - Madrid -, Spain, 28935
        • Novo Nordisk INvestigational Site
      • Palma de Mallorca, Spain, 07198
        • Novo Nordisk INvestigational Site
      • Pozuelo de Alarcon, Spain, 28223
        • Novo Nordisk INvestigational Site
      • Sevilla, Spain, 41003
        • Novo Nordisk INvestigational Site
      • Sevilla, Spain, 41014
        • Novo Nordisk INvestigational Site
      • Valladolid, Spain, 47005
        • Novo Nordisk INvestigational Site
      • Göteborg, Sweden, 413 45
        • Novo Nordisk INvestigational Site
      • Malmö, Sweden, 205 02
        • Novo Nordisk INvestigational Site
      • Stockholm, Sweden, 111 57
        • Novo Nordisk INvestigational Site
      • Stockholm, Sweden, 141 86
        • Novo Nordisk INvestigational Site
      • Stockholm, Sweden, 113 24
        • Novo Nordisk INvestigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk INvestigational Site
      • Changhua City, Taiwan, 500
        • Novo Nordisk INvestigational Site
      • Kaoshiung, Taiwan, 807
        • Novo Nordisk INvestigational Site
      • Tainan city, Taiwan, 710
        • Novo Nordisk INvestigational Site
      • Taoyuan, Taiwan, 333
        • Novo Nordisk INvestigational Site
      • Ankara, Turkey, 06100
        • Novo Nordisk INvestigational Site
      • Ankara, Turkey, 06500
        • Novo Nordisk INvestigational Site
      • Antalya, Turkey, 07058
        • Novo Nordisk INvestigational Site
      • Bursa, Turkey, 16059
        • Novo Nordisk INvestigational Site
      • Gaziantep, Turkey, 27070
        • Novo Nordisk INvestigational Site
      • Istanbul, Turkey, 34096
        • Novo Nordisk INvestigational Site
      • Istanbul, Turkey, 34098
        • Novo Nordisk INvestigational Site
      • Istanbul, Turkey, 34722
        • Novo Nordisk INvestigational Site
      • Istanbul, Turkey, 34390
        • Novo Nordisk INvestigational Site
      • Istanbul, Turkey, 34371
        • Novo Nordisk INvestigational Site
      • Istanbul, Turkey, 34890
        • Novo Nordisk INvestigational Site
      • Istanbul, Turkey, 34360
        • Novo Nordisk INvestigational Site
      • Istanbul, Turkey
        • Novo Nordisk INvestigational Site
      • Izmir, Turkey, 35100
        • Novo Nordisk INvestigational Site
      • Izmir, Turkey, 35340
        • Novo Nordisk INvestigational Site
      • Kayseri, Turkey, 38039
        • Novo Nordisk INvestigational Site
      • Dubai, United Arab Emirates, 7272
        • Novo Nordisk INvestigational Site
      • Dubai, United Arab Emirates, 4545
        • Novo Nordisk INvestigational Site
      • Aberdeen, United Kingdom, AB25 1LD
        • Novo Nordisk INvestigational Site
      • Birmingham, United Kingdom, B9 5SS
        • Novo Nordisk INvestigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk INvestigational Site
      • Coventry, United Kingdom, CV2 2DX
        • Novo Nordisk INvestigational Site
      • Devon, United Kingdom, EX2 5DW
        • Novo Nordisk INvestigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk INvestigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Novo Nordisk INvestigational Site
      • Glasgow, United Kingdom, G31 2ER
        • Novo Nordisk INvestigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk INvestigational Site
      • Hull, United Kingdom, HU3 2RW
        • Novo Nordisk INvestigational Site
      • Livington, United Kingdom, EH54 6PP
        • Novo Nordisk INvestigational Site
      • London, United Kingdom, W2 1NY
        • Novo Nordisk INvestigational Site
      • Manchester, United Kingdom, M6 8HD
        • Novo Nordisk INvestigational Site
      • Norwich, United Kingdom, NR4 7TJ
        • Novo Nordisk INvestigational Site
      • Nuneaton, United Kingdom, CV10 7DJ
        • Novo Nordisk INvestigational Site
      • Plymouth, United Kingdom, PL6 8BQ
        • Novo Nordisk INvestigational Site
      • St Helens, United Kingdom, WA9 3DA
        • Novo Nordisk INvestigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk INvestigational Site
      • Torquay, United Kingdom, TQ2 7AA
        • Novo Nordisk INvestigational Site
      • West Midlands, United Kingdom, B71 4HJ
        • Novo Nordisk INvestigational Site
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Novo Nordisk INvestigational Site
      • Birmingham, Alabama, United States, 35294
        • Novo Nordisk INvestigational Site
      • Birmingham, Alabama, United States, 35209
        • Novo Nordisk INvestigational Site
      • Huntsville, Alabama, United States, 35801
        • Novo Nordisk INvestigational Site
      • Mobile, Alabama, United States, 36608
        • Novo Nordisk INvestigational Site
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Novo Nordisk INvestigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novo Nordisk INvestigational Site
      • Little Rock, Arkansas, United States, 72205-5446
        • Novo Nordisk INvestigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk INvestigational Site
      • Cerritos, California, United States, 90703-2115
        • Novo Nordisk INvestigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk INvestigational Site
      • Fresno, California, United States, 93721-1443
        • Novo Nordisk INvestigational Site
      • Los Angeles, California, United States, 90017-4006
        • Novo Nordisk INvestigational Site
      • Los Banos, California, United States, 93635
        • Novo Nordisk INvestigational Site
      • Mission Hills, California, United States, 91345
        • Novo Nordisk INvestigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk INvestigational Site
      • San Diego, California, United States, 92111
        • Novo Nordisk INvestigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk INvestigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk INvestigational Site
      • Watsonville, California, United States, 95076
        • Novo Nordisk INvestigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045-7402
        • Novo Nordisk INvestigational Site
      • Denver, Colorado, United States, 80220
        • Novo Nordisk INvestigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Novo Nordisk INvestigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk INvestigational Site
      • Clearwater, Florida, United States, 33756
        • Novo Nordisk INvestigational Site
      • DeLand, Florida, United States, 32724
        • Novo Nordisk INvestigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • Novo Nordisk INvestigational Site
      • Kissimmee, Florida, United States, 34744
        • Novo Nordisk INvestigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk INvestigational Site
      • Orlando, Florida, United States, 32804
        • Novo Nordisk INvestigational Site
      • Saint Petersburg, Florida, United States, 33711
        • Novo Nordisk INvestigational Site
      • Tampa, Florida, United States, 33624
        • Novo Nordisk INvestigational Site
      • West Palm Beach, Florida, United States, 33409
        • Novo Nordisk INvestigational Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Novo Nordisk INvestigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk INvestigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk INvestigational Site
      • Chicago, Illinois, United States, 60612
        • Novo Nordisk INvestigational Site
      • Chicago, Illinois, United States, 60654
        • Novo Nordisk INvestigational Site
      • Crystal Lake, Illinois, United States, 60012
        • Novo Nordisk INvestigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260-1992
        • Novo Nordisk INvestigational Site
      • Michigan City, Indiana, United States, 46360
        • Novo Nordisk INvestigational Site
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Novo Nordisk INvestigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Novo Nordisk INvestigational Site
      • Louisville, Kentucky, United States, 40202
        • Novo Nordisk INvestigational Site
      • Louisville, Kentucky, United States, 40206
        • Novo Nordisk INvestigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006-2930
        • Novo Nordisk INvestigational Site
      • Monroe, Louisiana, United States, 71203
        • Novo Nordisk INvestigational Site
      • Natchitoches, Louisiana, United States, 71457-5881
        • Novo Nordisk INvestigational Site
      • New Orleans, Louisiana, United States, 70112
        • Novo Nordisk INvestigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Novo Nordisk INvestigational Site
      • Baltimore, Maryland, United States, 21218-2829
        • Novo Nordisk INvestigational Site
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Novo Nordisk INvestigational Site
      • Dearborn, Michigan, United States, 48124
        • Novo Nordisk INvestigational Site
      • Interlochen, Michigan, United States, 49643
        • Novo Nordisk INvestigational Site
      • Troy, Michigan, United States, 48085-5524
        • Novo Nordisk INvestigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk INvestigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Novo Nordisk INvestigational Site
      • Springfield, Missouri, United States, 65807
        • Novo Nordisk INvestigational Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Novo Nordisk INvestigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Novo Nordisk INvestigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Novo Nordisk INvestigational Site
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk INvestigational Site
    • New Jersey
      • Mine Hill, New Jersey, United States, 07803
        • Novo Nordisk INvestigational Site
      • Neptune, New Jersey, United States, 07753-4859
        • Novo Nordisk INvestigational Site
    • New York
      • Albany, New York, United States, 12208
        • Novo Nordisk INvestigational Site
      • Buffalo, New York, United States, 14221-7091
        • Novo Nordisk INvestigational Site
      • New York, New York, United States, 10032
        • Novo Nordisk INvestigational Site
      • New York, New York, United States, 10065
        • Novo Nordisk INvestigational Site
      • New York, New York, United States, 10036
        • Novo Nordisk INvestigational Site
      • Smithtown, New York, United States, 11787
        • Novo Nordisk INvestigational Site
      • Syracuse, New York, United States, 13210
        • Novo Nordisk INvestigational Site
      • Westfield, New York, United States, 14787
        • Novo Nordisk INvestigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Novo Nordisk INvestigational Site
      • Burlington, North Carolina, United States, 27215
        • Novo Nordisk INvestigational Site
      • Chapel Hill, North Carolina, United States, 27517
        • Novo Nordisk INvestigational Site
      • Greensboro, North Carolina, United States, 27401
        • Novo Nordisk INvestigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk INvestigational Site
      • Monroe, North Carolina, United States, 28110
        • Novo Nordisk INvestigational Site
      • Mooresville, North Carolina, United States, 28117
        • Novo Nordisk INvestigational Site
      • Morehead City, North Carolina, United States, 28557
        • Novo Nordisk INvestigational Site
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk INvestigational Site
    • Ohio
      • Cadiz, Ohio, United States, 43907
        • Novo Nordisk INvestigational Site
      • Cincinnati, Ohio, United States, 45219
        • Novo Nordisk INvestigational Site
      • Cincinnati, Ohio, United States, 45220-2213
        • Novo Nordisk INvestigational Site
      • Cleveland, Ohio, United States, 44106
        • Novo Nordisk INvestigational Site
      • Marion, Ohio, United States, 43302
        • Novo Nordisk INvestigational Site
      • Middleburg Heights, Ohio, United States, 44310
        • Novo Nordisk INvestigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novo Nordisk INvestigational Site
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk INvestigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk INvestigational Site
      • Beaver, Pennsylvania, United States, 15009-1957
        • Novo Nordisk INvestigational Site
      • Hatfield, Pennsylvania, United States, 19440
        • Novo Nordisk INvestigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk INvestigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk INvestigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • Novo Nordisk INvestigational Site
      • Uniontown, Pennsylvania, United States, 15401
        • Novo Nordisk INvestigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29455
        • Novo Nordisk INvestigational Site
      • Columbia, South Carolina, United States, 29203
        • Novo Nordisk INvestigational Site
      • Greenville, South Carolina, United States, 29607
        • Novo Nordisk INvestigational Site
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk INvestigational Site
      • Murrells Inlet, South Carolina, United States, 29576
        • Novo Nordisk INvestigational Site
      • Myrtle Beach, South Carolina, United States, 29572
        • Novo Nordisk INvestigational Site
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • Novo Nordisk INvestigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk INvestigational Site
      • Memphis, Tennessee, United States, 38163
        • Novo Nordisk INvestigational Site
      • Nashville, Tennessee, United States, 37212
        • Novo Nordisk INvestigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk INvestigational Site
      • Corpus Christi, Texas, United States, 78404
        • Novo Nordisk INvestigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk INvestigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk INvestigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk INvestigational Site
      • Dallas, Texas, United States, 75390
        • Novo Nordisk INvestigational Site
      • Houston, Texas, United States, 77070
        • Novo Nordisk INvestigational Site
      • Houston, Texas, United States, 77095
        • Novo Nordisk INvestigational Site
      • Longview, Texas, United States, 75605
        • Novo Nordisk INvestigational Site
      • Lubbock, Texas, United States, 79423
        • Novo Nordisk INvestigational Site
      • Odessa, Texas, United States, 79761
        • Novo Nordisk INvestigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk INvestigational Site
      • San Antonio, Texas, United States, 78228-3419
        • Novo Nordisk INvestigational Site
      • Schertz, Texas, United States, 78154
        • Novo Nordisk INvestigational Site
      • Tomball, Texas, United States, 77375
        • Novo Nordisk INvestigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Novo Nordisk INvestigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Novo Nordisk INvestigational Site
    • Washington
      • Spokane, Washington, United States, 99210
        • Novo Nordisk INvestigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
Experimental: Liraglutide
Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
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)
Time From Randomisation to All Cause Death
Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
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)
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
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)
Time From Randomisation to First Occurrence of a Composite Microvascular Outcome
Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

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)
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2010

Primary Completion (Actual)

December 17, 2015

Study Completion (Actual)

December 17, 2015

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (Estimate)

August 10, 2010

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • EX2211-3748
  • 2009-012201-19 (EudraCT Number)
  • U1111-1113-7090 (Other Identifier: WHO)
  • CTR20130003 (Other Identifier: CFDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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