- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01179048
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
Conditions
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
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Novo Nordisk INvestigational Site
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Queensland
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Douglas, Queensland, Australia, 4814
- Novo Nordisk INvestigational Site
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Herston, Queensland, Australia, 4029
- Novo Nordisk INvestigational Site
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Meadowbrook, Queensland, Australia, 4131
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South Australia
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Keswick, South Australia, Australia, 5035
- Novo Nordisk INvestigational Site
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Oaklands Park, South Australia, Australia, 5046
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Tasmania
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Hobart, Tasmania, Australia, 7000
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Victoria
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Box Hill, Victoria, Australia, 3128
- Novo Nordisk INvestigational Site
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Fitzroy, Victoria, Australia, 3065
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Western Australia
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Fremantle, Western Australia, Australia, 6160
- Novo Nordisk INvestigational Site
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Graz, Austria, 8036
- Novo Nordisk INvestigational Site
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Wien, Austria, 1090
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Wien, Austria, 1130
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Wien, Austria, 1030
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Wien, Austria, 1140
- Novo Nordisk INvestigational Site
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Edegem, Belgium, 2650
- Novo Nordisk INvestigational Site
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
- Novo Nordisk INvestigational Site
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Liège, Belgium, 4000
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Aracajú, Brazil, 49020-270
- Novo Nordisk INvestigational Site
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Belo Horizonte, Brazil, 30150-221
- Novo Nordisk INvestigational Site
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Campinas, Brazil, 13084-971
- Novo Nordisk INvestigational Site
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Curitiba, Brazil, 80420-011
- Novo Nordisk INvestigational Site
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Fortaleza, Brazil, 60430-350
- Novo Nordisk INvestigational Site
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Goiânia, Brazil, 74110-120
- Novo Nordisk INvestigational Site
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Joinville, Brazil, 05001-100
- Novo Nordisk INvestigational Site
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Marília, Brazil, 17519-000
- Novo Nordisk INvestigational Site
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Porto Alegre, Brazil, 90035-170
- Novo Nordisk INvestigational Site
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Recife, Brazil, 52020-010
- Novo Nordisk INvestigational Site
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Rio de Janeiro, Brazil, 20211-340
- Novo Nordisk INvestigational Site
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Rio de Janeiro, Brazil, 20551-030
- Novo Nordisk INvestigational Site
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Santos, Brazil, 11045-904
- Novo Nordisk INvestigational Site
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Sao Paulo, Brazil, 01323-001
- Novo Nordisk INvestigational Site
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Sao Paulo, Brazil, 04011-030
- Novo Nordisk INvestigational Site
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São Paulo, Brazil, 05403-000
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Ceara
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Fortaleza, Ceara, Brazil, 60192-340
- Novo Nordisk INvestigational Site
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Fortaleza, Ceara, Brazil, 60115-282
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Fortaleza, Ceara, Brazil, 60170-001
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Goias
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Aparecida de Goiania, Goias, Brazil, 74935-530
- Novo Nordisk INvestigational Site
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Para
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Belém, Para, Brazil, 66073-000
- Novo Nordisk INvestigational Site
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Parana
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Curitiba, Parana, Brazil, 80030-110
- Novo Nordisk INvestigational Site
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Curitiba, Parana, Brazil, 80810-040
- Novo Nordisk INvestigational Site
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Curitiba, Parana, Brazil, 80010-030
- Novo Nordisk INvestigational Site
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Rio Grande Do Sul
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Caxias Do Sul, Rio Grande Do Sul, Brazil, 95070-560
- Novo Nordisk INvestigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
- Novo Nordisk INvestigational Site
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Sao Paulo
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Campinas, Sao Paulo, Brazil, 13059-740
- Novo Nordisk INvestigational Site
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Campinas, Sao Paulo, Brazil, 13073-350
- Novo Nordisk INvestigational Site
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Mogi das Cruzes, Sao Paulo, Brazil, 08780-090
- Novo Nordisk INvestigational Site
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São Paulo, Sao Paulo, Brazil, 05403-000
- Novo Nordisk INvestigational Site
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São Paulo, Sao Paulo, Brazil, 01223-001
- Novo Nordisk INvestigational Site
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São Paulo, Sao Paulo, Brazil, 01228-000
- Novo Nordisk INvestigational Site
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São Paulo, Sao Paulo, Brazil, 01228-200
- Novo Nordisk INvestigational Site
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São Paulo, Sao Paulo, Brazil, 04012-909
- Novo Nordisk INvestigational Site
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São Paulo, Sao Paulo, Brazil, 04020-041
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Quebec, Canada, G1V 4G2
- Novo Nordisk INvestigational Site
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Quebec, Canada, G1V 4G5
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Alberta
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Edmonton, Alberta, Canada, T5J 3N4
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3X8
- Novo Nordisk INvestigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
- Novo Nordisk INvestigational Site
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Newfoundland and Labrador
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St.John's, Newfoundland and Labrador, Canada, A1B 3V6
- Novo Nordisk INvestigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Novo Nordisk INvestigational Site
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Ontario
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Cambridge, Ontario, Canada, N1R 7L6
- Novo Nordisk INvestigational Site
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Cornwall, Ontario, Canada, K6H 4M4
- Novo Nordisk INvestigational Site
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London, Ontario, Canada, N6G 2M1
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London, Ontario, Canada, N6A 4V2
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Mississauga, Ontario, Canada, L5M 2V8
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Scarborough, Ontario, Canada, M1E 5E9
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Smiths Falls, Ontario, Canada, K7A 4W8
- Novo Nordisk INvestigational Site
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Thunder Bay, Ontario, Canada, P7A 4V7
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Toronto, Ontario, Canada, M5C 2T2
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Toronto, Ontario, Canada, M5T 3L9
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Quebec
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Montreal, Quebec, Canada, H2W 1R7
- Novo Nordisk INvestigational Site
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Beijing
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Beijing, Beijing, China, 100044
- Novo Nordisk INvestigational Site
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Beijing, Beijing, China, 100730
- Novo Nordisk INvestigational Site
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Beijing, Beijing, China, 100853
- Novo Nordisk INvestigational Site
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Fujian
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Xiamen, Fujian, China, 361003
- Novo Nordisk INvestigational Site
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Novo Nordisk INvestigational Site
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Jiangsu
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Zhenjiang, Jiangsu, China, 212001
- Novo Nordisk INvestigational Site
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Shandong
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Qingdao, Shandong, China, 266003
- Novo Nordisk INvestigational Site
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Shanghai
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Shanghai, Shanghai, China, 200003
- Novo Nordisk INvestigational Site
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Plzen, Czechia, 304 60
- Novo Nordisk INvestigational Site
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Praha, Czechia, 128 08
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Aalborg, Denmark, 9100
- Novo Nordisk INvestigational Site
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Esbjerg, Denmark, 6700
- Novo Nordisk INvestigational Site
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Gentofte, Denmark, 2820
- Novo Nordisk INvestigational Site
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Hvidovre, Denmark, 2650
- Novo Nordisk INvestigational Site
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Odense, Denmark, 5000
- Novo Nordisk INvestigational Site
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Århus C, Denmark, 8000
- Novo Nordisk INvestigational Site
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Kuopio, Finland, 70210
- Novo Nordisk INvestigational Site
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Lahti, Finland, 15110
- Novo Nordisk INvestigational Site
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Oulu, Finland, 90220
- Novo Nordisk INvestigational Site
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Tampere, Finland, 33520
- Novo Nordisk INvestigational Site
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Vantaa, Finland, FIN-01600
- Novo Nordisk INvestigational Site
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Corbeil Essonnes, France, 91106
- Novo Nordisk INvestigational Site
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Jarny, France, 54800
- Novo Nordisk INvestigational Site
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Nimes, France, 30006
- Novo Nordisk INvestigational Site
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Paris, France, 75877
- Novo Nordisk INvestigational Site
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Angermünde/OT Wolletz, Germany, 16278
- Novo Nordisk INvestigational Site
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Aschaffenburg, Germany, 63739
- Novo Nordisk INvestigational Site
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Berlin, Germany, 12163
- Novo Nordisk INvestigational Site
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Berlin, Germany, 13055
- Novo Nordisk INvestigational Site
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Dillingen, Germany, 89407
- Novo Nordisk INvestigational Site
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Dresden, Germany, 01219
- Novo Nordisk INvestigational Site
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Elsterwerda, Germany, 04910
- Novo Nordisk INvestigational Site
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Essen, Germany, 45219
- Novo Nordisk INvestigational Site
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Falkensee, Germany, 14612
- Novo Nordisk INvestigational Site
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Gifhorn, Germany, 38518
- Novo Nordisk INvestigational Site
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Hamburg, Germany, 22587
- Novo Nordisk INvestigational Site
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Karlsbad, Germany, 76307
- Novo Nordisk INvestigational Site
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Leipzig, Germany, 04103
- Novo Nordisk INvestigational Site
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Leipzig, Germany, 04275
- Novo Nordisk INvestigational Site
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Ludwigshafen, Germany, 67059
- Novo Nordisk INvestigational Site
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Mannheim, Germany, 68163
- Novo Nordisk INvestigational Site
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München, Germany, 80336
- Novo Nordisk INvestigational Site
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Oldenburg, Germany, 23758
- Novo Nordisk INvestigational Site
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Saint Ingbert-Oberwürzbach, Germany, 66386
- Novo Nordisk INvestigational Site
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Schkeuditz, Germany, 04435
- Novo Nordisk INvestigational Site
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Schweinfurt, Germany, 97421
- Novo Nordisk INvestigational Site
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Ulm, Germany, 89081
- Novo Nordisk INvestigational Site
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Villingen-Schwenningen, Germany, 78048
- Novo Nordisk INvestigational Site
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Wangen, Germany, 88239
- Novo Nordisk INvestigational Site
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Athens, Greece, GR-11527
- Novo Nordisk INvestigational Site
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Athens, Greece, GR-10552
- Novo Nordisk INvestigational Site
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Crete, Greece, 71001
- Novo Nordisk INvestigational Site
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Thessaloniki, Greece, GR-57001
- Novo Nordisk INvestigational Site
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Thriruvananthapuram, India, 695 032
- Novo Nordisk INvestigational Site
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500034
- Novo Nordisk INvestigational Site
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Hyderbad, Andhra Pradesh, India, 500 012
- Novo Nordisk INvestigational Site
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Assam
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Guwahati, Assam, India, 781007
- Novo Nordisk INvestigational Site
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Haryana
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Karnal, Haryana, India, 132001
- Novo Nordisk INvestigational Site
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Karnataka
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Bangalore, Karnataka, India, 560043
- Novo Nordisk INvestigational Site
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Bangalore, Karnataka, India, 560052
- Novo Nordisk INvestigational Site
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Bangalore, Karnataka, India, 560 003
- Novo Nordisk INvestigational Site
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Manipal, Karnataka, India, 576104
- Novo Nordisk INvestigational Site
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Kerala
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Kochi, Kerala, India, 682041
- Novo Nordisk INvestigational Site
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Madhya Pradesh
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Indore, Madhya Pradesh, India, 452010
- Novo Nordisk INvestigational Site
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Maharashtra
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Mumbai, Maharashtra, India, 400012
- Novo Nordisk INvestigational Site
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Punjab
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Chandigarh, Punjab, India, 160012
- Novo Nordisk INvestigational Site
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600086
- Novo Nordisk INvestigational Site
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Chennai, Tamil Nadu, India, 600029
- Novo Nordisk INvestigational Site
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Madurai, Tamil Nadu, India, 625 020
- Novo Nordisk INvestigational Site
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Vellore, Tamil Nadu, India, 632004
- Novo Nordisk INvestigational Site
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West Bengal
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Kolkata, West Bengal, India, 700054
- Novo Nordisk INvestigational Site
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Dublin, Ireland, DUBLIN 4
- Novo Nordisk INvestigational Site
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Dublin 9, Ireland
- Novo Nordisk INvestigational Site
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Haifa, Israel, 31096
- Novo Nordisk INvestigational Site
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Haifa, Israel, 35152
- Novo Nordisk INvestigational Site
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Jerusalem, Israel, 91120
- Novo Nordisk INvestigational Site
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Petah-Tikva, Israel, 49372
- Novo Nordisk INvestigational Site
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Tel Hashomer, Israel, 52621
- Novo Nordisk INvestigational Site
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Bologna, Italy, 40138
- Novo Nordisk INvestigational Site
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Catanzaro, Italy, 88100
- Novo Nordisk INvestigational Site
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Chieti, Italy, 66100
- Novo Nordisk INvestigational Site
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Firenze, Italy, 50141
- Novo Nordisk INvestigational Site
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Latina, Italy, 04100
- Novo Nordisk INvestigational Site
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Lucca, Italy, 55100
- Novo Nordisk INvestigational Site
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Milano, Italy, 20132
- Novo Nordisk INvestigational Site
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Padova, Italy, 35128
- Novo Nordisk INvestigational Site
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Palermo, Italy, 90127
- Novo Nordisk INvestigational Site
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Roma, Italy, 00161
- Novo Nordisk INvestigational Site
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Roma, Italy, 00133
- Novo Nordisk INvestigational Site
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Goyang, Korea, Republic of, 410-719
- Novo Nordisk INvestigational Site
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Seongnam-si, Korea, Republic of, 463-707
- Novo Nordisk INvestigational Site
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Seoul, Korea, Republic of, 139-827
- Novo Nordisk INvestigational Site
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Seoul, Korea, Republic of, 02447
- Novo Nordisk INvestigational Site
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Seoul, Korea, Republic of, 137-701
- Novo Nordisk INvestigational Site
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Aguascalientes, Mexico, 20230
- Novo Nordisk INvestigational Site
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Durango, Mexico, 34000
- Novo Nordisk INvestigational Site
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Durango, Mexico, 34080
- Novo Nordisk INvestigational Site
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Monterrey, Mexico, 64460
- Novo Nordisk INvestigational Site
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San Luis Potosi, Mexico, 78200
- Novo Nordisk INvestigational Site
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Baja California Norte
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Tijuana, Baja California Norte, Mexico, 22010
- Novo Nordisk INvestigational Site
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Jalisco
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Guadalajara, Jalisco, Mexico, 44600
- Novo Nordisk INvestigational Site
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Guadalajara, Jalisco, Mexico, 44650
- Novo Nordisk INvestigational Site
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Amsterdam, Netherlands, 1066 EC
- Novo Nordisk INvestigational Site
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Eindhoven, Netherlands, 5631 BM
- Novo Nordisk INvestigational Site
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Etten-Leur, Netherlands, 4872 LP
- Novo Nordisk INvestigational Site
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Goes, Netherlands, 4461 LT
- Novo Nordisk INvestigational Site
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Groningen, Netherlands, 9728 NT
- Novo Nordisk INvestigational Site
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Hoogeveen, Netherlands, 7909 AA
- Novo Nordisk INvestigational Site
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Maastricht, Netherlands, 6229 HX
- Novo Nordisk INvestigational Site
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Nijmegen, Netherlands, 6525 GA
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Utrecht, Netherlands, 3584 CX
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Oslo, Norway, 0586
- Novo Nordisk INvestigational Site
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Oslo, Norway, 0407
- Novo Nordisk INvestigational Site
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Stavanger, Norway, 4011
- Novo Nordisk INvestigational Site
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Trondheim, Norway, 7030
- Novo Nordisk INvestigational Site
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Tønsberg, Norway, 3117
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Bialystok, Poland, 15-435
- Novo Nordisk INvestigational Site
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Bydgoszcz, Poland, 85-822
- Novo Nordisk INvestigational Site
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Katowice, Poland, 40-084
- Novo Nordisk INvestigational Site
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Krakow, Poland, 31-501
- Novo Nordisk INvestigational Site
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Krakow, Poland, 31-271
- Novo Nordisk INvestigational Site
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Krakow, Poland, 31-261
- Novo Nordisk INvestigational Site
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Lodz, Poland, 93-338
- Novo Nordisk INvestigational Site
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Poznan, Poland, 60-569
- Novo Nordisk INvestigational Site
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Pulawy, Poland, 24-100
- Novo Nordisk INvestigational Site
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Ruda Slaska, Poland, 41-709
- Novo Nordisk INvestigational Site
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Warszawa, Poland, 02-507
- Novo Nordisk INvestigational Site
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Warszawa, Poland, 01-192
- Novo Nordisk INvestigational Site
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Wroclaw, Poland, 50-381
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Bayamon, Puerto Rico, 00961
- Novo Nordisk INvestigational Site
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Caguas, Puerto Rico, 00725
- Novo Nordisk INvestigational Site
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Bacau, Romania, 600114
- Novo Nordisk INvestigational Site
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Bucharest, Romania, 020475
- Novo Nordisk INvestigational Site
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Constanta, Romania, 900591
- Novo Nordisk INvestigational Site
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Deva, Romania, 330084
- Novo Nordisk INvestigational Site
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Iasi, Romania, 700547
- Novo Nordisk INvestigational Site
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Satu Mare, Romania, 440055
- Novo Nordisk INvestigational Site
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Sibiu, Romania, 550245
- Novo Nordisk INvestigational Site
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Dolj
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Craiova, Dolj, Romania, 200642
- Novo Nordisk INvestigational Site
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Mures
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Targu Mures, Mures, Romania, 540098
- Novo Nordisk INvestigational Site
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Timis
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Timisoara, Timis, Romania, 300736
- Novo Nordisk INvestigational Site
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Arkhangelsk, Russian Federation, 163045
- Novo Nordisk INvestigational Site
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Arkhangelsk, Russian Federation, 163001
- Novo Nordisk INvestigational Site
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Barnaul, Russian Federation, 656045
- Novo Nordisk INvestigational Site
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Kazan, Russian Federation, 420043
- Novo Nordisk INvestigational Site
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Moscow, Russian Federation, 119435
- Novo Nordisk INvestigational Site
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Moscow, Russian Federation, 117036
- Novo Nordisk INvestigational Site
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Moscow, Russian Federation, 125367
- Novo Nordisk INvestigational Site
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Moscow, Russian Federation, 127486
- Novo Nordisk INvestigational Site
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Nizhniy Novgorod, Russian Federation, 603126
- Novo Nordisk INvestigational Site
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Penza, Russian Federation, 440026
- Novo Nordisk INvestigational Site
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Saratov, Russian Federation, 410053
- Novo Nordisk INvestigational Site
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Smolensk, Russian Federation, 214019
- Novo Nordisk INvestigational Site
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Tumen, Russian Federation, 625023
- Novo Nordisk INvestigational Site
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Yaroslavl, Russian Federation, 150062
- Novo Nordisk INvestigational Site
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Belgrade, Serbia, 11000
- Novo Nordisk INvestigational Site
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Alberton, South Africa, 1449
- Novo Nordisk INvestigational Site
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Cape Town, South Africa, 7530
- Novo Nordisk INvestigational Site
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Free State
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Bloemfontein, Free State, South Africa, 9301
- Novo Nordisk INvestigational Site
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Gauteng
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Johannesburg, Gauteng, South Africa, 1829
- Novo Nordisk INvestigational Site
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Johannesburg, Gauteng, South Africa, 2013
- Novo Nordisk INvestigational Site
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Lenasia, Gauteng, South Africa, 1827
- Novo Nordisk INvestigational Site
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Midrand, Gauteng, South Africa, 1685
- Novo Nordisk INvestigational Site
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Pretoria, Gauteng, South Africa, 0181
- Novo Nordisk INvestigational Site
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Pretoria, Gauteng, South Africa, 0083
- Novo Nordisk INvestigational Site
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Pretoria, Gauteng, South Africa, 0001
- Novo Nordisk INvestigational Site
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KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa, 4126
- Novo Nordisk INvestigational Site
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Durban, KwaZulu-Natal, South Africa, 4091
- Novo Nordisk INvestigational Site
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Durban, KwaZulu-Natal, South Africa, 4320
- Novo Nordisk INvestigational Site
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Tongaat, KwaZulu-Natal, South Africa, 4400
- Novo Nordisk INvestigational Site
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Western Cape
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Cape Town, Western Cape, South Africa
- Novo Nordisk INvestigational Site
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Somerset West, Western Cape, South Africa, 7130
- Novo Nordisk INvestigational Site
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Almería, Spain, 04001
- Novo Nordisk INvestigational Site
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Barcelona, Spain, 08036
- Novo Nordisk INvestigational Site
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La Coruña, Spain, 15006
- Novo Nordisk INvestigational Site
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Madrid, Spain, 28040
- Novo Nordisk INvestigational Site
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Mora De Ebre, Spain, 43740
- Novo Nordisk INvestigational Site
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Mostoles - Madrid -, Spain, 28935
- Novo Nordisk INvestigational Site
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Palma de Mallorca, Spain, 07198
- Novo Nordisk INvestigational Site
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Pozuelo de Alarcon, Spain, 28223
- Novo Nordisk INvestigational Site
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Sevilla, Spain, 41003
- Novo Nordisk INvestigational Site
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Sevilla, Spain, 41014
- Novo Nordisk INvestigational Site
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Valladolid, Spain, 47005
- Novo Nordisk INvestigational Site
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Göteborg, Sweden, 413 45
- Novo Nordisk INvestigational Site
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Malmö, Sweden, 205 02
- Novo Nordisk INvestigational Site
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Stockholm, Sweden, 111 57
- Novo Nordisk INvestigational Site
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Stockholm, Sweden, 141 86
- Novo Nordisk INvestigational Site
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Stockholm, Sweden, 113 24
- Novo Nordisk INvestigational Site
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Örebro, Sweden, 701 85
- Novo Nordisk INvestigational Site
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Changhua City, Taiwan, 500
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Kaoshiung, Taiwan, 807
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Tainan city, Taiwan, 710
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Taoyuan, Taiwan, 333
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Ankara, Turkey, 06100
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Ankara, Turkey, 06500
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Antalya, Turkey, 07058
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Bursa, Turkey, 16059
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Gaziantep, Turkey, 27070
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Istanbul, Turkey, 34096
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Istanbul, Turkey, 34098
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Istanbul, Turkey, 34722
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Istanbul, Turkey, 34390
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Istanbul, Turkey, 34371
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Istanbul, Turkey, 34890
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Istanbul, Turkey, 34360
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Istanbul, Turkey
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Izmir, Turkey, 35100
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Izmir, Turkey, 35340
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Kayseri, Turkey, 38039
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Dubai, United Arab Emirates, 7272
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Dubai, United Arab Emirates, 4545
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Aberdeen, United Kingdom, AB25 1LD
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Birmingham, United Kingdom, B9 5SS
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Bristol, United Kingdom, BS10 5NB
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Coventry, United Kingdom, CV2 2DX
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Devon, United Kingdom, EX2 5DW
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Dundee, United Kingdom, DD1 9SY
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Edinburgh, United Kingdom, EH16 4SA
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Glasgow, United Kingdom, G31 2ER
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Guildford, United Kingdom, GU2 7XX
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Hull, United Kingdom, HU3 2RW
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Livington, United Kingdom, EH54 6PP
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London, United Kingdom, W2 1NY
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Manchester, United Kingdom, M6 8HD
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Norwich, United Kingdom, NR4 7TJ
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Nuneaton, United Kingdom, CV10 7DJ
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Plymouth, United Kingdom, PL6 8BQ
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St Helens, United Kingdom, WA9 3DA
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Swansea, United Kingdom, SA6 6NL
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Torquay, United Kingdom, TQ2 7AA
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West Midlands, United Kingdom, B71 4HJ
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Alabama
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Alabaster, Alabama, United States, 35007
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Birmingham, Alabama, United States, 35294
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Birmingham, Alabama, United States, 35209
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Huntsville, Alabama, United States, 35801
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Mobile, Alabama, United States, 36608
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Arizona
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Tempe, Arizona, United States, 85283
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Arkansas
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Little Rock, Arkansas, United States, 72205
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Little Rock, Arkansas, United States, 72205-5446
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California
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Anaheim, California, United States, 92801
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Cerritos, California, United States, 90703-2115
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Escondido, California, United States, 92025
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Fresno, California, United States, 93721-1443
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Los Angeles, California, United States, 90017-4006
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Los Banos, California, United States, 93635
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Mission Hills, California, United States, 91345
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Montclair, California, United States, 91763
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San Diego, California, United States, 92111
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Tustin, California, United States, 92780
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Walnut Creek, California, United States, 94598
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Watsonville, California, United States, 95076
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Colorado
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Aurora, Colorado, United States, 80045-7402
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Denver, Colorado, United States, 80220
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Delaware
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Newark, Delaware, United States, 19713
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Florida
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Bradenton, Florida, United States, 34201
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Clearwater, Florida, United States, 33756
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DeLand, Florida, United States, 32724
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Fort Lauderdale, Florida, United States, 33316
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Kissimmee, Florida, United States, 34744
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Miami, Florida, United States, 33136
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Orlando, Florida, United States, 32804
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Saint Petersburg, Florida, United States, 33711
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Tampa, Florida, United States, 33624
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West Palm Beach, Florida, United States, 33409
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Georgia
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Lawrenceville, Georgia, United States, 30046
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Roswell, Georgia, United States, 30076
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Illinois
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Chicago, Illinois, United States, 60607
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Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60654
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Crystal Lake, Illinois, United States, 60012
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Indiana
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Indianapolis, Indiana, United States, 46260-1992
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Michigan City, Indiana, United States, 46360
- Novo Nordisk INvestigational Site
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Iowa
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West Des Moines, Iowa, United States, 50265
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Kentucky
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Lexington, Kentucky, United States, 40502
- Novo Nordisk INvestigational Site
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Louisville, Kentucky, United States, 40202
- Novo Nordisk INvestigational Site
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Louisville, Kentucky, United States, 40206
- Novo Nordisk INvestigational Site
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Louisiana
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Metairie, Louisiana, United States, 70006-2930
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Monroe, Louisiana, United States, 71203
- Novo Nordisk INvestigational Site
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Natchitoches, Louisiana, United States, 71457-5881
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New Orleans, Louisiana, United States, 70112
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Maryland
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Baltimore, Maryland, United States, 21204
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Baltimore, Maryland, United States, 21218-2829
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Michigan
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Bloomfield Hills, Michigan, United States, 48302
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Dearborn, Michigan, United States, 48124
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Interlochen, Michigan, United States, 49643
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Troy, Michigan, United States, 48085-5524
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Minnesota
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Minneapolis, Minnesota, United States, 55416
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Missouri
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Saint Louis, Missouri, United States, 63108
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Springfield, Missouri, United States, 65807
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Montana
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Great Falls, Montana, United States, 59405
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Nebraska
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Omaha, Nebraska, United States, 68105
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
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Nashua, New Hampshire, United States, 03063
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New Jersey
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Mine Hill, New Jersey, United States, 07803
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Neptune, New Jersey, United States, 07753-4859
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New York
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Albany, New York, United States, 12208
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Buffalo, New York, United States, 14221-7091
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New York, New York, United States, 10032
- Novo Nordisk INvestigational Site
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New York, New York, United States, 10065
- Novo Nordisk INvestigational Site
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New York, New York, United States, 10036
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Smithtown, New York, United States, 11787
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Syracuse, New York, United States, 13210
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Westfield, New York, United States, 14787
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North Carolina
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Asheville, North Carolina, United States, 28801
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Burlington, North Carolina, United States, 27215
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Chapel Hill, North Carolina, United States, 27517
- Novo Nordisk INvestigational Site
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Greensboro, North Carolina, United States, 27401
- Novo Nordisk INvestigational Site
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Greenville, North Carolina, United States, 27834
- Novo Nordisk INvestigational Site
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Monroe, North Carolina, United States, 28110
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Mooresville, North Carolina, United States, 28117
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Morehead City, North Carolina, United States, 28557
- Novo Nordisk INvestigational Site
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Whiteville, North Carolina, United States, 28472
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Ohio
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Cadiz, Ohio, United States, 43907
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Cincinnati, Ohio, United States, 45219
- Novo Nordisk INvestigational Site
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Cincinnati, Ohio, United States, 45220-2213
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Cleveland, Ohio, United States, 44106
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Marion, Ohio, United States, 43302
- Novo Nordisk INvestigational Site
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Middleburg Heights, Ohio, United States, 44310
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- Novo Nordisk INvestigational Site
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Oklahoma City, Oklahoma, United States, 73104
- Novo Nordisk INvestigational Site
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- Novo Nordisk INvestigational Site
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Beaver, Pennsylvania, United States, 15009-1957
- Novo Nordisk INvestigational Site
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Hatfield, Pennsylvania, United States, 19440
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15243
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Uniontown, Pennsylvania, United States, 15401
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South Carolina
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Charleston, South Carolina, United States, 29455
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Columbia, South Carolina, United States, 29203
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Greenville, South Carolina, United States, 29607
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Greer, South Carolina, United States, 29651
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Murrells Inlet, South Carolina, United States, 29576
- Novo Nordisk INvestigational Site
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Myrtle Beach, South Carolina, United States, 29572
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Tennessee
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Bartlett, Tennessee, United States, 38133
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Kingsport, Tennessee, United States, 37660
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Memphis, Tennessee, United States, 38163
- Novo Nordisk INvestigational Site
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Nashville, Tennessee, United States, 37212
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Texas
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Arlington, Texas, United States, 76014
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Corpus Christi, Texas, United States, 78404
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75246
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Dallas, Texas, United States, 75390
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Houston, Texas, United States, 77070
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Houston, Texas, United States, 77095
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Longview, Texas, United States, 75605
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Lubbock, Texas, United States, 79423
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Odessa, Texas, United States, 79761
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San Antonio, Texas, United States, 78229
- Novo Nordisk INvestigational Site
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San Antonio, Texas, United States, 78228-3419
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Schertz, Texas, United States, 78154
- Novo Nordisk INvestigational Site
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Tomball, Texas, United States, 77375
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Utah
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Salt Lake City, Utah, United States, 84102
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Vermont
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South Burlington, Vermont, United States, 05403
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Washington
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Spokane, Washington, United States, 99210
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Wisconsin
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Madison, Wisconsin, United States, 53717
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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:
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.
Sponsor
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
- 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 Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.
- Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
- 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.
- Verma S, Al-Omran M, Leiter LA, Mazer CD, Rasmussen S, Saevereid HA, Sejersten Ripa M, Bonaca MP. Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease. Diabetes Obes Metab. 2022 Jul;24(7):1288-1299. doi: 10.1111/dom.14700. Epub 2022 Apr 11.
- Verma S, McGuire DK, Bain SC, Bhatt DL, Leiter LA, Mazer CD, Monk Fries T, Pratley RE, Rasmussen S, Vrazic H, Zinman B, Buse JB. Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Dec;22(12):2487-2492. doi: 10.1111/dom.14160. Epub 2020 Sep 4.
- Verma S, Bain SC, Honore JB, F E Mann J, A Nauck M, E Pratley R, Rasmussen S, Sejersten Ripa M, Zinman B, Buse JB. Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2020 Nov;22(11):2193-2198. doi: 10.1111/dom.14140. Epub 2020 Aug 12.
- Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3.
- 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.
- 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 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial. J Hypertens. 2016 Jun;34(6):1140-50. doi: 10.1097/HJH.0000000000000890.
- 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 with type 2 diabetes mellitus: baseline global data from the LEADER trial. Cardiovasc Diabetol. 2016 Feb 10;15:29. doi: 10.1186/s12933-016-0341-5.
- Satman I, R Rea R, Eriksson M, Mosenzon O, Pratley R, M Baeres F, D Orsted 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. 2016 Nov-Dec;30(8):1631-1639. doi: 10.1016/j.jdiacomp.2016.06.001. Epub 2016 Jun 3.
- Rutten GE, Tack CJ, Pieber TR, Comlekci A, Orsted 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. doi: 10.1186/s13098-016-0153-5. eCollection 2016.
- 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 (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2.
- 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 over 9000 subjects in the LEADER Trial. Pancreas. 2014 Nov;43(8):1223-31. doi: 10.1097/MPA.0000000000000229.
- Daniels GH, Hegedus L, Marso SP, Nauck MA, Zinman B, Bergenstal RM, Mann JF, Derving Karsbol 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 and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations. Diabetes Obes Metab. 2015 May;17(5):477-86. doi: 10.1111/dom.12444. Epub 2015 Feb 23.
- Steinberg WM, Buse JB, Ghorbani MLM, Orsted 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. Diabetes Care. 2017 Jul;40(7):966-972. doi: 10.2337/dc16-2747. Epub 2017 May 5.
- Mann JFE, Orsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornoe 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/NEJMoa1616011.
- Hegedus L, Sherman SI, Tuttle RM, von Scholten BJ, Rasmussen S, Karsbol 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 Response to Liraglutide for Up to 5 Years in the LEADER Trial. Diabetes Care. 2018 Mar;41(3):620-622. doi: 10.2337/dc17-1956. Epub 2017 Dec 26.
- 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 Therapy (from the LEADER Trial). Am J Cardiol. 2018 Jun 15;121(12):1467-1470. doi: 10.1016/j.amjcard.2018.02.030. Epub 2018 Mar 15.
- 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 Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Polyvascular Disease: Results of the LEADER Trial. Circulation. 2018 May 15;137(20):2179-2183. doi: 10.1161/CIRCULATIONAHA.118.033898. No abstract available.
- 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. Diabetes Care. 2018 Aug;41(8):1663-1671. doi: 10.2337/dc17-1825. Epub 2018 Jun 13.
- 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. doi: 10.2337/dc17-2677. Epub 2018 Jun 14.
- Nauck MA, Tornoe 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 in the LEADER trial. Diab Vasc Dis Res. 2018 Sep;15(5):465-468. doi: 10.1177/1479164118783935. Epub 2018 Jun 27.
- Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L, Kaltoft MS, Stellfeld M, Tornoe K, Pratley RE; LEADER Publication Committee on behalf of the LEADER Trial Investigators. The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial. Diabetes Care. 2018 Oct;41(10):2229-2235. doi: 10.2337/dc18-1094. Epub 2018 Aug 2.
- 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 Lipoprotein Cholesterol Levels and Statin Use. Circulation. 2018 Oct 9;138(15):1605-1607. doi: 10.1161/CIRCULATIONAHA.118.036862. No abstract available.
- 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):2908-2918. doi: 10.1161/CIRCULATIONAHA.118.036418.
- Verma S, Poulter NR, Bhatt DL, Bain SC, Buse JB, Leiter LA, Nauck MA, Pratley RE, Zinman B, Orsted 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 of Myocardial Infarction or Stroke. Circulation. 2018 Dec 18;138(25):2884-2894. doi: 10.1161/CIRCULATIONAHA.118.034516.
- 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. Diabetes Obes Metab. 2019 Mar;21(3):525-532. doi: 10.1111/dom.13547. Epub 2018 Oct 25.
- Zinman B, Nauck MA, Bosch-Traberg H, Frimer-Larsen H, Orsted 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: 10.1007/s13300-018-0524-z. Epub 2018 Nov 3.
- Gilbert MP, Bain SC, Franek E, Jodar-Gimeno E, Nauck MA, Pratley R, Rea RR, Kerr Saraiva JF, Rasmussen S, Tornoe K, von Scholten BJ, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled Trial. Ann Intern Med. 2019 Mar 19;170(6):423-426. doi: 10.7326/M18-1569. Epub 2018 Dec 4. No abstract available.
- Heller SR, Geybels MS, Iqbal A, Liu L, Wagner L, Chow E. A higher non-severe hypoglycaemia rate is associated with an increased risk of subsequent severe hypoglycaemia and major adverse cardiovascular events in individuals with type 2 diabetes in the LEADER study. Diabetologia. 2022 Jan;65(1):55-64. doi: 10.1007/s00125-021-05556-7. Epub 2021 Oct 26.
- Persson F, Bain SC, Mosenzon O, Heerspink HJL, Mann JFE, Pratley R, Raz I, Idorn T, Rasmussen S, von Scholten BJ, Rossing P; LEADER Trial Investigators. Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial. Diabetes Care. 2021 Apr;44(4):1020-1026. doi: 10.2337/dc20-1622. Epub 2021 Jan 27.
- Crowley MJ, McGuire DK, Alexopoulos AS, Jensen TJ, Rasmussen S, Saevereid HA, Verma S, Buse JB. Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial. Diabetes Care. 2020 Sep;43(9):e108-e110. doi: 10.2337/dc20-0437. Epub 2020 Jul 9. No abstract available.
- Buse JB, Bain SC, Mann JFE, Nauck MA, Nissen SE, Pocock S, Poulter NR, Pratley RE, Linder M, Monk Fries T, Orsted DD, Zinman B; LEADER Trial Investigators. Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial. Diabetes Care. 2020 Jul;43(7):1546-1552. doi: 10.2337/dc19-2251. Epub 2020 May 4.
- Marso SP, Baeres FMM, Bain SC, Goldman B, Husain M, Nauck MA, Poulter NR, Pratley RE, Thomsen AB, Buse JB; LEADER Trial Investigators. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure. J Am Coll Cardiol. 2020 Mar 17;75(10):1128-1141. doi: 10.1016/j.jacc.2019.12.063.
- Mann JFE, Fonseca VA, Poulter NR, Raz I, Idorn T, Rasmussen S, von Scholten BJ, Mosenzon O; LEADER Trial Investigators. Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease. Clin J Am Soc Nephrol. 2020 Apr 7;15(4):465-473. doi: 10.2215/CJN.11881019. Epub 2020 Mar 4.
- Nauck MA, Kreiner E, Rasmussen S, Saevereid HA, Buse JB; LEADER Trial Investigators. Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920. Diabetes Care. 2020 Feb;43(2):e30-e31. doi: 10.2337/dci19-0067. No abstract available.
- Verma S, Bain SC, Buse JB, Idorn T, Rasmussen S, Orsted DD, Nauck MA. Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2019 Dec 1;4(12):1214-1220. doi: 10.1001/jamacardio.2019.3080.
- Nauck MA, Muus Ghorbani ML, Kreiner E, Saevereid HA, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care. 2019 Oct;42(10):1912-1920. doi: 10.2337/dc19-0415. Epub 2019 Aug 9.
- Tack CJ, Jacob S, Desouza C, Bain SC, Buse JB, Nauck MA, Petrie JR, Poulter NR, Pratley RE, Stegmann HVBK, Bosch-Traberg H, Startseva E, Zinman B; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial. Diabetes Obes Metab. 2019 Nov;21(11):2450-2458. doi: 10.1111/dom.13826. Epub 2019 Jul 7.
Helpful Links
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
Additional Relevant MeSH Terms
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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