A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE)
10 luglio 2019 aggiornato da: Novo Nordisk A/S
This trial is conducted globally.
The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
7637
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Algiers, Algeria, 16000
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Constantine, Algeria, 25000
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Oran, Algeria, 31000
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Sidi Bel Abbes, Algeria, 22000
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Caba, Argentina, C1440AAD
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Cordoba, Argentina, 5000
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Mar del Plata, Argentina, B7600FZN
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Rosario, Argentina, S2000CUD
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Zarate, Argentina, B2800DGH
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Fortaleza, Brasile, 60430-350
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Porto Alegre, Brasile, 90035-170
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Ceara
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Fortaleza, Ceara, Brasile, 60115-282
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Distrito Federal
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Brasília, Distrito Federal, Brasile, 71625-009
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Goias
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Aparecida de Goiania, Goias, Brasile, 74935-530
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Para
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Belém, Para, Brasile, 66073-000
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Sao Paulo
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Mogi das Cruzes, Sao Paulo, Brasile, 08780-090
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São Paulo, Sao Paulo, Brasile, 05403-000
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São Paulo, Sao Paulo, Brasile, 01223-001
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São Paulo, Sao Paulo, Brasile, 01228-000
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São Paulo, Sao Paulo, Brasile, 01228-200
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Alberta
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Edmonton, Alberta, Canada, T5J 3N4
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
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Ontario
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Chatham, Ontario, Canada, N7L 1C1
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Ottawa, Ontario, Canada, K1K 4L2
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Sarnia, Ontario, Canada, N7T 4X3
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Quebec
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Laval, Quebec, Canada, H7T 2P5
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Goyang, Corea, Repubblica di, 10380
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Seoul, Corea, Repubblica di, 02841
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Seoul, Corea, Repubblica di, 03080
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Suwon-si, Gyeonggi-do, Corea, Repubblica di, 16247
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Bjelovar, Croazia, 43000
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Osijek, Croazia, 31 000
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Slavonski Brod, Croazia, 35 000
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Zagreb, Croazia, 10 000
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Zagreb, Croazia, 10000
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Ekaterinburg, Federazione Russa, 620102
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Kemerovo, Federazione Russa, 650002
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Kirov, Federazione Russa, 610014
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Krasnodar, Federazione Russa, 350012
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Krasnodar, Federazione Russa, 350086
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Moscow, Federazione Russa, 123423
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Moscow, Federazione Russa, 111539
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Nizhny Novgorod, Federazione Russa, 603018
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Rostov-on-Don, Federazione Russa, 344068
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Saint-Petersburg, Federazione Russa, 194356
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Saint-Petersburg, Federazione Russa, 195213
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Saint-Petersburg, Federazione Russa, 191119
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Saratov, Federazione Russa, 410053
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Saratov, Federazione Russa, 410031
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St. Petersburg, Federazione Russa, 194354
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St. Petersburg, Federazione Russa, 196084
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Syktyvkar, Federazione Russa, 167981
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Tumen, Federazione Russa, 625023
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Tver, Federazione Russa, 170036
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Ulianovsk, Federazione Russa, 432063
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Volgograd, Federazione Russa, 400131
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Yaroslavl, Federazione Russa, 150010
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Chuo-ku, Tokyo, Giappone, 103-0002
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Kanagawa, Giappone, 235-0045
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Kumamoto, Giappone, 862-0976
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Miyazaki, Giappone, 880-0034
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Nagano, Giappone, 390-8621
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Ota-ku, Giappone, 144 0035
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Ota-ku, Tokyo, Giappone, 1430015
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Shinjuku-ku, Tokyo, Giappone, 162-8655
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Athens, Grecia, GR-17562
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Athens, Grecia, GR-11527
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Athens, Grecia, GR-115 27
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Athens, Grecia, GR-10552
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Thessaloniki, Grecia, GR-57001
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Thessaloniki, Grecia, GR-54642
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Ludhiana, India, 141001
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New Delhi, India, 110001
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500034
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Hyderbad, Andhra Pradesh, India, 500 012
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Gujarat
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Ahmedabad, Gujarat, India, 380006
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Ahmedabad, Gujarat, India, 380052
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Ahmedabad, Gujarat, India, 380007
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Ahmedabad, Gujarat, India, 380016
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Haryana
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Gurgaon, Haryana, India, 122001
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Karnataka
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Bangalore, Karnataka, India, 560034
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Bangalore, Karnataka, India, 560 017
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Kerala
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Kozhikode, Kerala, India, 673017
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Madhya Pradesh
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Indore, Madhya Pradesh, India, 452010
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Maharashtra
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Goa, Maharashtra, India, 403 202
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Mumbai, Maharashtra, India, 400008
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Mumbai, Maharashtra, India, 400012
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Mumbai, Maharashtra, India, 400022
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Mumbai, Maharashtra, India, 400010
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Mumbai, Maharashtra, India, 400007
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Pune, Maharashtra, India, 411001
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Pune, Maharashtra, India, 411040
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New Delhi
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New Dehli, New Delhi, India, 110029
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Orissa
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Bhubaneswar, Orissa, India, 751005
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Punjab
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Mohali, Punjab, India, 160062
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600086
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Chennai, Tamil Nadu, India, 600031
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Coimbatore, Tamil Nadu, India, 641018
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226014
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West Bengal
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Kolkata, West Bengal, India, 700020
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Kolkata, West Bengal, India, 700054
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Bari, Italia, 70124
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Bergamo, Italia, 24127
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Catanzaro, Italia, 88100
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Chieti, Italia, 66100
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Milano, Italia, 20122
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Milano, Italia, 20162
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Milano (MI), Italia, 20132
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Olbia, Italia, 07026
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Padova, Italia, 35143
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Palermo, Italia, 90127
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Ravenna, Italia, 48121
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Roma, Italia, 00161
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Roma, Italia, 00133
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Sesto San Giovanni (MI), Italia, 20099
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Alor Setar, Malaysia, 05460
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Kota Samarahan, Malaysia, 94300
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Kuala Lumpur, Malaysia, 59100
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Kuantan, Malaysia, 25100
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Melaka, Malaysia, 75400
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Serdang, Malaysia, 43000
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Seremban, Malaysia, 70300
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Aguascalientes, Messico, 20230
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Chihuahua, Messico, 31200
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San Luis Potosi, Messico, 78200
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Jalisco
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Guadalajara, Jalisco, Messico, 44600
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Guadalajara, Jalisco, Messico, 44130
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Guadalajara, Jalisco, Messico, 44650
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Guadalajara, Jalisco, Messico, 44670
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Guadalajara, Jalisco, Messico, 44150
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Morelos
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Cuernavaca, Morelos, Messico, 62250
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México, D.F.
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Distrito Federal, México, D.F., Messico, 14080
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Bytom, Polonia, 41-902
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Gdansk, Polonia, 80-546
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Krakow, Polonia, 31-455
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Oswiecim, Polonia, 32-600
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Poznan, Polonia, 60-589
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Szczecin, Polonia, 70-506
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Warszawa, Polonia, 02-507
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Zamosc, Polonia, 22-400
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Bristol, Regno Unito, BS10 5NB
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Dundee, Regno Unito, DD1 9SY
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Edinburgh, Regno Unito, EH4 2XU
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Guildford, Regno Unito, GU2 7XX
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Norwich, Regno Unito, NR4 7TJ
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Nuneaton, Regno Unito, CV10 7DJ
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Stevenage, Regno Unito, SG1 4AB
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Wolverhampton, Regno Unito, WV10 0QP
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Alba
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Alba Iulia, Alba, Romania, 510053
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Maramures
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Baia Mare, Maramures, Romania, 430222
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Mures
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Targu Mures, Mures, Romania, 540142
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Prahova
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Ploiesti, Prahova, Romania, 100163
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Granada, Spagna, 18012
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Granada, Spagna, 18003
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Madrid, Spagna, 28046
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Málaga, Spagna, 29006
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Sevilla, Spagna, 41009
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Valencia, Spagna, 46014
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Valencia, Spagna, 46015
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
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Birmingham, Alabama, Stati Uniti, 35216
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Montgomery, Alabama, Stati Uniti, 36106
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Montgomery, Alabama, Stati Uniti, 36109
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Arizona
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Gilbert, Arizona, Stati Uniti, 85295
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Glendale, Arizona, Stati Uniti, 85308
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Litchfield Park, Arizona, Stati Uniti, 85340
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Phoenix, Arizona, Stati Uniti, 85050
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Tucson, Arizona, Stati Uniti, 85714
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Tucson, Arizona, Stati Uniti, 85704
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Tucson, Arizona, Stati Uniti, 85723
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
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Little Rock, Arkansas, Stati Uniti, 72205-5446
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Searcy, Arkansas, Stati Uniti, 72143
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California
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Chula Vista, California, Stati Uniti, 91910
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Concord, California, Stati Uniti, 94520
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Downey, California, Stati Uniti, 90242
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Duarte, California, Stati Uniti, 91010
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Encino, California, Stati Uniti, 91436
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Fresno, California, Stati Uniti, 93720
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Greenbrae, California, Stati Uniti, 94904
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Huntington Beach, California, Stati Uniti, 92648
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Inglewood, California, Stati Uniti, 90301
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La Jolla, California, Stati Uniti, 92037
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La Mesa, California, Stati Uniti, 91942
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Lancaster, California, Stati Uniti, 93534
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Long Beach, California, Stati Uniti, 90822
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Los Alamitos, California, Stati Uniti, 90720
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Mission Hills, California, Stati Uniti, 91345
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Montclair, California, Stati Uniti, 91763
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Monterey, California, Stati Uniti, 93940
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North Hollywood, California, Stati Uniti, 91606
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Palm Springs, California, Stati Uniti, 92262
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Poway, California, Stati Uniti, 92064
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San Diego, California, Stati Uniti, 92111
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San Diego, California, Stati Uniti, 92120
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San Ramon, California, Stati Uniti, 94583
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Santa Ana, California, Stati Uniti, 92704
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Sherman Oaks, California, Stati Uniti, 91403
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Thousand Oaks, California, Stati Uniti, 91360
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Tustin, California, Stati Uniti, 92780
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Ventura, California, Stati Uniti, 93003
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Vista, California, Stati Uniti, 92083
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Westminster, California, Stati Uniti, 92683
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80909
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Denver, Colorado, Stati Uniti, 80220
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Denver, Colorado, Stati Uniti, 80246
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Golden, Colorado, Stati Uniti, 80401
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Connecticut
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Danbury, Connecticut, Stati Uniti, 06810
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Norwalk, Connecticut, Stati Uniti, 06851
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Waterbury, Connecticut, Stati Uniti, 06708
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Florida
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Boca Raton, Florida, Stati Uniti, 33433
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Boynton Beach, Florida, Stati Uniti, 33472
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Bradenton, Florida, Stati Uniti, 34201
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Brandon, Florida, Stati Uniti, 33511
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Clearwater, Florida, Stati Uniti, 33756
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Cooper City, Florida, Stati Uniti, 33024
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Fleming Island, Florida, Stati Uniti, 32003
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Fort Lauderdale, Florida, Stati Uniti, 33316
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Gainesville, Florida, Stati Uniti, 32610
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Green Cove Springs, Florida, Stati Uniti, 32043
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Hialeah, Florida, Stati Uniti, 33012
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Jacksonville, Florida, Stati Uniti, 32216
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Jacksonville, Florida, Stati Uniti, 32207
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Miami, Florida, Stati Uniti, 33135
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Miami, Florida, Stati Uniti, 33136
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Miami, Florida, Stati Uniti, 33183
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Miami, Florida, Stati Uniti, 33155
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Miami, Florida, Stati Uniti, 33165
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Naples, Florida, Stati Uniti, 34119
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New Port Richey, Florida, Stati Uniti, 34652
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Orlando, Florida, Stati Uniti, 32806
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Panama City, Florida, Stati Uniti, 32401
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Ponte Vedra, Florida, Stati Uniti, 32081
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Port Charlotte, Florida, Stati Uniti, 33952
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Port Orange, Florida, Stati Uniti, 32127
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South Miami, Florida, Stati Uniti, 33143
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Tampa, Florida, Stati Uniti, 33624
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Tampa, Florida, Stati Uniti, 33619
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Georgia
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Atlanta, Georgia, Stati Uniti, 30339
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Decatur, Georgia, Stati Uniti, 30033
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Dunwoody, Georgia, Stati Uniti, 30338
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Lawrenceville, Georgia, Stati Uniti, 30046
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Roswell, Georgia, Stati Uniti, 30076
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Savannah, Georgia, Stati Uniti, 31406
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96814
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Idaho
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Idaho Falls, Idaho, Stati Uniti, 83404-7596
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Illinois
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Addison, Illinois, Stati Uniti, 60101
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Champaign, Illinois, Stati Uniti, 61821
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Chicago, Illinois, Stati Uniti, 60607
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Chicago, Illinois, Stati Uniti, 60616
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Crystal Lake, Illinois, Stati Uniti, 60012
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Gurnee, Illinois, Stati Uniti, 60031
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Hines, Illinois, Stati Uniti, 60141
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Springfield, Illinois, Stati Uniti, 62711
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Springfield, Illinois, Stati Uniti, 62702
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Indiana
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Brownsburg, Indiana, Stati Uniti, 46112
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Evansville, Indiana, Stati Uniti, 47714
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Franklin, Indiana, Stati Uniti, 46131
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Greenfield, Indiana, Stati Uniti, 46140
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Indianapolis, Indiana, Stati Uniti, 46254
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Michigan City, Indiana, Stati Uniti, 46360
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Muncie, Indiana, Stati Uniti, 47304
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Iowa
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Council Bluffs, Iowa, Stati Uniti, 51501
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Kansas
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Wichita, Kansas, Stati Uniti, 67205
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
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Lexington, Kentucky, Stati Uniti, 40502
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Louisville, Kentucky, Stati Uniti, 40213
- Novo Nordisk Investigational Site
-
Louisville, Kentucky, Stati Uniti, 40206
- Novo Nordisk Investigational Site
-
Madisonville, Kentucky, Stati Uniti, 42431
- Novo Nordisk Investigational Site
-
-
Louisiana
-
Monroe, Louisiana, Stati Uniti, 71203
- Novo Nordisk Investigational Site
-
New Orleans, Louisiana, Stati Uniti, 70119
- Novo Nordisk Investigational Site
-
Shreveport, Louisiana, Stati Uniti, 71103
- Novo Nordisk Investigational Site
-
Slidell, Louisiana, Stati Uniti, 70461-4231
- Novo Nordisk Investigational Site
-
-
Maine
-
Bangor, Maine, Stati Uniti, 04401
- Novo Nordisk Investigational Site
-
-
Maryland
-
Hyattsville, Maryland, Stati Uniti, 20782
- Novo Nordisk Investigational Site
-
Rockville, Maryland, Stati Uniti, 20852
- Novo Nordisk Investigational Site
-
-
Massachusetts
-
Watertown, Massachusetts, Stati Uniti, 02472
- Novo Nordisk Investigational Site
-
Worcester, Massachusetts, Stati Uniti, 01655
- Novo Nordisk Investigational Site
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48106
- Novo Nordisk Investigational Site
-
Ann Arbor, Michigan, Stati Uniti, 48105
- Novo Nordisk Investigational Site
-
Buckley, Michigan, Stati Uniti, 49620
- Novo Nordisk Investigational Site
-
Detroit, Michigan, Stati Uniti, 48201
- Novo Nordisk Investigational Site
-
Detroit, Michigan, Stati Uniti, 48202
- Novo Nordisk Investigational Site
-
Kalamazoo, Michigan, Stati Uniti, 49009
- Novo Nordisk Investigational Site
-
Livonia, Michigan, Stati Uniti, 48152
- Novo Nordisk Investigational Site
-
Troy, Michigan, Stati Uniti, 48098
- Novo Nordisk Investigational Site
-
-
Mississippi
-
Olive Branch, Mississippi, Stati Uniti, 38654
- Novo Nordisk Investigational Site
-
-
Missouri
-
Hazelwood, Missouri, Stati Uniti, 63042
- Novo Nordisk Investigational Site
-
Jefferson City, Missouri, Stati Uniti, 65109
- Novo Nordisk Investigational Site
-
Kansas City, Missouri, Stati Uniti, 64111
- Novo Nordisk Investigational Site
-
-
Montana
-
Billings, Montana, Stati Uniti, 59101
- Novo Nordisk Investigational Site
-
Kalispell, Montana, Stati Uniti, 59901
- Novo Nordisk Investigational Site
-
-
Nebraska
-
Elkhorn, Nebraska, Stati Uniti, 68022
- Novo Nordisk Investigational Site
-
Fremont, Nebraska, Stati Uniti, 68025
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Stati Uniti, 68114
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Stati Uniti, 68105
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Stati Uniti, 68124
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Stati Uniti, 68144
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Stati Uniti, 68198-4120
- Novo Nordisk Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89148
- Novo Nordisk Investigational Site
-
Las Vegas, Nevada, Stati Uniti, 89128
- Novo Nordisk Investigational Site
-
Las Vegas, Nevada, Stati Uniti, 89120
- Novo Nordisk Investigational Site
-
-
New Hampshire
-
Nashua, New Hampshire, Stati Uniti, 03063
- Novo Nordisk Investigational Site
-
-
New Jersey
-
East Brunswick, New Jersey, Stati Uniti, 08816
- Novo Nordisk Investigational Site
-
Hoboken, New Jersey, Stati Uniti, 07030
- Novo Nordisk Investigational Site
-
-
New York
-
Albany, New York, Stati Uniti, 12206
- Novo Nordisk Investigational Site
-
Lake Success, New York, Stati Uniti, 11042
- Novo Nordisk Investigational Site
-
Mineola, New York, Stati Uniti, 11501
- Novo Nordisk Investigational Site
-
New Windsor, New York, Stati Uniti, 12553
- Novo Nordisk Investigational Site
-
New York, New York, Stati Uniti, 10029
- Novo Nordisk Investigational Site
-
North Massapequa, New York, Stati Uniti, 11758-1802
- Novo Nordisk Investigational Site
-
Northport, New York, Stati Uniti, 11768
- Novo Nordisk Investigational Site
-
Rochester, New York, Stati Uniti, 14607
- Novo Nordisk Investigational Site
-
West Seneca, New York, Stati Uniti, 14224
- Novo Nordisk Investigational Site
-
Westfield, New York, Stati Uniti, 14787
- Novo Nordisk Investigational Site
-
-
North Carolina
-
Asheville, North Carolina, Stati Uniti, 28803
- Novo Nordisk Investigational Site
-
Asheville, North Carolina, Stati Uniti, 28801
- Novo Nordisk Investigational Site
-
Burlington, North Carolina, Stati Uniti, 27215
- Novo Nordisk Investigational Site
-
Cary, North Carolina, Stati Uniti, 27518
- Novo Nordisk Investigational Site
-
Chapel Hill, North Carolina, Stati Uniti, 27517
- Novo Nordisk Investigational Site
-
Charlotte, North Carolina, Stati Uniti, 28209
- Novo Nordisk Investigational Site
-
Greenville, North Carolina, Stati Uniti, 27834
- Novo Nordisk Investigational Site
-
Lexington, North Carolina, Stati Uniti, 27292
- Novo Nordisk Investigational Site
-
Morehead City, North Carolina, Stati Uniti, 28557
- Novo Nordisk Investigational Site
-
New Bern, North Carolina, Stati Uniti, 28562
- Novo Nordisk Investigational Site
-
Statesville, North Carolina, Stati Uniti, 28625
- Novo Nordisk Investigational Site
-
Whiteville, North Carolina, Stati Uniti, 28472
- Novo Nordisk Investigational Site
-
Wilmington, North Carolina, Stati Uniti, 28401
- Novo Nordisk Investigational Site
-
Winston-Salem, North Carolina, Stati Uniti, 27103
- Novo Nordisk Investigational Site
-
-
North Dakota
-
Fargo, North Dakota, Stati Uniti, 58104
- Novo Nordisk Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, Stati Uniti, 45236
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, Stati Uniti, 44195
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, Stati Uniti, 44106-1702
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, Stati Uniti, 44121
- Novo Nordisk Investigational Site
-
Columbus, Ohio, Stati Uniti, 43235
- Novo Nordisk Investigational Site
-
Delaware, Ohio, Stati Uniti, 43015
- Novo Nordisk Investigational Site
-
Franklin, Ohio, Stati Uniti, 45005
- Novo Nordisk Investigational Site
-
Maumee, Ohio, Stati Uniti, 43537
- Novo Nordisk Investigational Site
-
Mentor, Ohio, Stati Uniti, 44060
- Novo Nordisk Investigational Site
-
Perrysburg, Ohio, Stati Uniti, 43551
- Novo Nordisk Investigational Site
-
-
Oklahoma
-
Norman, Oklahoma, Stati Uniti, 73069
- Novo Nordisk Investigational Site
-
Oklahoma City, Oklahoma, Stati Uniti, 73104
- Novo Nordisk Investigational Site
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97239-3098
- Novo Nordisk Investigational Site
-
-
Pennsylvania
-
Altoona, Pennsylvania, Stati Uniti, 16602
- Novo Nordisk Investigational Site
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Beaver, Pennsylvania, Stati Uniti, 15009
- Novo Nordisk Investigational Site
-
Danville, Pennsylvania, Stati Uniti, 17822
- Novo Nordisk Investigational Site
-
Hermitage, Pennsylvania, Stati Uniti, 16148
- Novo Nordisk Investigational Site
-
Philadelphia, Pennsylvania, Stati Uniti, 19107
- Novo Nordisk Investigational Site
-
Philadelphia, Pennsylvania, Stati Uniti, 19114
- Novo Nordisk Investigational Site
-
Pittsburgh, Pennsylvania, Stati Uniti, 15243
- Novo Nordisk Investigational Site
-
Pittsburgh, Pennsylvania, Stati Uniti, 15212
- Novo Nordisk Investigational Site
-
Smithfield, Pennsylvania, Stati Uniti, 15478
- Novo Nordisk Investigational Site
-
Uniontown, Pennsylvania, Stati Uniti, 15401
- Novo Nordisk Investigational Site
-
Upper Darby, Pennsylvania, Stati Uniti, 19082
- Novo Nordisk Investigational Site
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Wilkes-Barre, Pennsylvania, Stati Uniti, 18702
- Novo Nordisk Investigational Site
-
-
South Carolina
-
Anderson, South Carolina, Stati Uniti, 29621
- Novo Nordisk Investigational Site
-
Greer, South Carolina, Stati Uniti, 29651
- Novo Nordisk Investigational Site
-
Moncks Corner, South Carolina, Stati Uniti, 29461
- Novo Nordisk Investigational Site
-
Murrells Inlet, South Carolina, Stati Uniti, 29576
- Novo Nordisk Investigational Site
-
Myrtle Beach, South Carolina, Stati Uniti, 29572
- Novo Nordisk Investigational Site
-
Orangeburg, South Carolina, Stati Uniti, 29118
- Novo Nordisk Investigational Site
-
Spartanburg, South Carolina, Stati Uniti, 29303
- Novo Nordisk Investigational Site
-
-
Tennessee
-
Chattanooga, Tennessee, Stati Uniti, 37404
- Novo Nordisk Investigational Site
-
Chattanooga, Tennessee, Stati Uniti, 37411
- Novo Nordisk Investigational Site
-
Chattanooga, Tennessee, Stati Uniti, 37404-1192
- Novo Nordisk Investigational Site
-
Kingsport, Tennessee, Stati Uniti, 37660
- Novo Nordisk Investigational Site
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Knoxville, Tennessee, Stati Uniti, 37938
- Novo Nordisk Investigational Site
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Memphis, Tennessee, Stati Uniti, 38119
- Novo Nordisk Investigational Site
-
Memphis, Tennessee, Stati Uniti, 38163
- Novo Nordisk Investigational Site
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Nashville, Tennessee, Stati Uniti, 37212
- Novo Nordisk Investigational Site
-
Nashville, Tennessee, Stati Uniti, 37203
- Novo Nordisk Investigational Site
-
Nashville, Tennessee, Stati Uniti, 37208
- Novo Nordisk Investigational Site
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Tullahoma, Tennessee, Stati Uniti, 37388
- Novo Nordisk Investigational Site
-
-
Texas
-
Arlington, Texas, Stati Uniti, 76012
- Novo Nordisk Investigational Site
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Austin, Texas, Stati Uniti, 78731
- Novo Nordisk Investigational Site
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Austin, Texas, Stati Uniti, 78749
- Novo Nordisk Investigational Site
-
Austin, Texas, Stati Uniti, 78705
- Novo Nordisk Investigational Site
-
Carrollton, Texas, Stati Uniti, 75010
- Novo Nordisk Investigational Site
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Carrollton, Texas, Stati Uniti, 75007
- Novo Nordisk Investigational Site
-
Corpus Christi, Texas, Stati Uniti, 78404
- Novo Nordisk Investigational Site
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Dallas, Texas, Stati Uniti, 75230
- Novo Nordisk Investigational Site
-
Dallas, Texas, Stati Uniti, 75390-9302
- Novo Nordisk Investigational Site
-
Dallas, Texas, Stati Uniti, 75231
- Novo Nordisk Investigational Site
-
Dallas, Texas, Stati Uniti, 75246
- Novo Nordisk Investigational Site
-
Fort Worth, Texas, Stati Uniti, 76117
- Novo Nordisk Investigational Site
-
Fort Worth, Texas, Stati Uniti, 76132
- Novo Nordisk Investigational Site
-
Houston, Texas, Stati Uniti, 77024
- Novo Nordisk Investigational Site
-
Houston, Texas, Stati Uniti, 77061
- Novo Nordisk Investigational Site
-
Houston, Texas, Stati Uniti, 77008
- Novo Nordisk Investigational Site
-
Houston, Texas, Stati Uniti, 77070
- Novo Nordisk Investigational Site
-
Houston, Texas, Stati Uniti, 77099
- Novo Nordisk Investigational Site
-
Houston, Texas, Stati Uniti, 77060
- Novo Nordisk Investigational Site
-
Houston, Texas, Stati Uniti, 77029
- Novo Nordisk Investigational Site
-
Houston, Texas, Stati Uniti, 77093
- Novo Nordisk Investigational Site
-
Humble, Texas, Stati Uniti, 77338
- Novo Nordisk Investigational Site
-
Hurst, Texas, Stati Uniti, 76054
- Novo Nordisk Investigational Site
-
Irving, Texas, Stati Uniti, 75039
- Novo Nordisk Investigational Site
-
Lewisville, Texas, Stati Uniti, 75067
- Novo Nordisk Investigational Site
-
Longview, Texas, Stati Uniti, 75605
- Novo Nordisk Investigational Site
-
Lubbock, Texas, Stati Uniti, 79423
- Novo Nordisk Investigational Site
-
Midland, Texas, Stati Uniti, 79707
- Novo Nordisk Investigational Site
-
Odessa, Texas, Stati Uniti, 79761
- Novo Nordisk Investigational Site
-
Pearland, Texas, Stati Uniti, 77584
- Novo Nordisk Investigational Site
-
Richardson, Texas, Stati Uniti, 75080
- Novo Nordisk Investigational Site
-
Round Rock, Texas, Stati Uniti, 78681
- Novo Nordisk Investigational Site
-
San Antonio, Texas, Stati Uniti, 78229
- Novo Nordisk Investigational Site
-
San Antonio, Texas, Stati Uniti, 78215
- Novo Nordisk Investigational Site
-
San Antonio, Texas, Stati Uniti, 78228-6205
- Novo Nordisk Investigational Site
-
San Antonio, Texas, Stati Uniti, 78258
- Novo Nordisk Investigational Site
-
Splendora, Texas, Stati Uniti, 77372
- Novo Nordisk Investigational Site
-
Sugar Land, Texas, Stati Uniti, 77478
- Novo Nordisk Investigational Site
-
Sugar Land, Texas, Stati Uniti, 77479
- Novo Nordisk Investigational Site
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Waco, Texas, Stati Uniti, 76710
- Novo Nordisk Investigational Site
-
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Utah
-
Salt Lake City, Utah, Stati Uniti, 84102
- Novo Nordisk Investigational Site
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Salt Lake City, Utah, Stati Uniti, 84132
- Novo Nordisk Investigational Site
-
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Vermont
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Bennington, Vermont, Stati Uniti, 05201
- Novo Nordisk Investigational Site
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South Burlington, Vermont, Stati Uniti, 05403
- Novo Nordisk Investigational Site
-
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Virginia
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Midlothian, Virginia, Stati Uniti, 23114
- Novo Nordisk Investigational Site
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Norfolk, Virginia, Stati Uniti, 23510
- Novo Nordisk Investigational Site
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Richmond, Virginia, Stati Uniti, 23249
- Novo Nordisk Investigational Site
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Winchester, Virginia, Stati Uniti, 22601-3834
- Novo Nordisk Investigational Site
-
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Washington
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Richland, Washington, Stati Uniti, 99352
- Novo Nordisk Investigational Site
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Spokane, Washington, Stati Uniti, 99201
- Novo Nordisk Investigational Site
-
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Wisconsin
-
Kenosha, Wisconsin, Stati Uniti, 53144
- Novo Nordisk Investigational Site
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Milwaukee, Wisconsin, Stati Uniti, 53209
- Novo Nordisk Investigational Site
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Milwaukee, Wisconsin, Stati Uniti, 53295
- Novo Nordisk Investigational Site
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-
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Eastern Cape
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Port Elizabeth, Eastern Cape, Sud Africa, 6045
- Novo Nordisk Investigational Site
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Port Elizabeth, Eastern Cape, Sud Africa, 6014
- Novo Nordisk Investigational Site
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Gauteng
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Johannesburg, Gauteng, Sud Africa, 2193
- Novo Nordisk Investigational Site
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Johannesburg, Gauteng, Sud Africa, 1818
- Novo Nordisk Investigational Site
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Johannesburg, Gauteng, Sud Africa, 2198
- Novo Nordisk Investigational Site
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Pretoria, Gauteng, Sud Africa, 0001
- Novo Nordisk Investigational Site
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sud Africa, 4001
- Novo Nordisk Investigational Site
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Durban, KwaZulu-Natal, Sud Africa, 4092
- Novo Nordisk Investigational Site
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Umkomaas, KwaZulu-Natal, Sud Africa, 4170
- Novo Nordisk Investigational Site
-
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Mpumalanga
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Middleburg, Mpumalanga, Sud Africa, 1055
- Novo Nordisk Investigational Site
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North West
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Brits, North West, Sud Africa, 0250
- Novo Nordisk Investigational Site
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Western Cape
-
Cape Town, Western Cape, Sud Africa, 7130
- Novo Nordisk Investigational Site
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Cape Town, Western Cape, Sud Africa, 7500
- Novo Nordisk Investigational Site
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Cape Town, Western Cape, Sud Africa, 7700
- Novo Nordisk Investigational Site
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Cape Town, Western Cape, Sud Africa, 7460
- Novo Nordisk Investigational Site
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-
-
-
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Bangkok, Tailandia, 10400
- Novo Nordisk Investigational Site
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Bangkok, Tailandia, 10330
- Novo Nordisk Investigational Site
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Bangkoknoi, Bangkok, Tailandia, 10700
- Novo Nordisk Investigational Site
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Chiang Mai, Tailandia, 50200
- Novo Nordisk Investigational Site
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Nakhon Ratchasima, Tailandia, 30000
- Novo Nordisk Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
50 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s) Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Insulin degludec (IDeg)
All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
|
Injected once daily subcutaneously (s.c., under the skin)
|
|
Comparatore attivo: Insulin glargine (IGlar)
All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
|
Injected once daily subcutaneously (s.c., under the skin)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Lasso di tempo: From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)
|
Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke.
Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses.
The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented.
The trial was event driven and planned to last up to a maximum of 60.5 months.
The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months.
The maximum trial duration for a single subject was 33.1 months.
|
From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of EAC-confirmed Severe Hypoglycaemic Episodes
Lasso di tempo: From randomisation to individual end of trial (maximum patient year observation: 2.75 years)
|
Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months).
The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.
The trial was event driven and planned to last up to a maximum of 60.5 months.
The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months.
The maximum trial duration for a single subject was 33.1 months.
|
From randomisation to individual end of trial (maximum patient year observation: 2.75 years)
|
|
Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no)
Lasso di tempo: From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)
|
Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months).
The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.
|
From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)
|
|
Change in Glycosylated Haemoglobin (HbA1c)
Lasso di tempo: Randomisation to 24 months
|
Mean change in HbA1c from week 0 to month 24.
|
Randomisation to 24 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Pollock RF, Heller S, Pieber TR, Woo V, Gundgaard J, Hallen N, Luckevich M, Tutkunkardas D, Zinman B; DEVOTE Study Group. Short-term cost-utility of degludec versus glargine U100 for patients with type 2 diabetes at high risk of hypoglycaemia and cardiovascular events: A Canadian setting (DEVOTE 9). Diabetes Obes Metab. 2019 Jul;21(7):1706-1714. doi: 10.1111/dom.13730. Epub 2019 Apr 14.
- Pollock RF, Valentine WJ, Marso SP, Andersen A, Gundgaard J, Hallen N, Tutkunkardas D, Magnuson EA, Buse JB; DEVOTE study group. Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16). Appl Health Econ Health Policy. 2019 Oct;17(5):615-627. doi: 10.1007/s40258-019-00494-3.
- Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Frandsen KB, Rabol R, Buse JB. Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) - DEVOTE 1. Am Heart J. 2016 Sep;179:175-83. doi: 10.1016/j.ahj.2016.06.004. Epub 2016 Jun 18.
- Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Brown-Frandsen K, Moses A, Skibsted S, Kvist K, Buse JB; DEVOTE Study Group. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med. 2017 Aug 24;377(8):723-732. doi: 10.1056/NEJMoa1615692. Epub 2017 Jun 12.
- Zinman B, Marso SP, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Lange M, Brown-Frandsen K, Moses A, Ocampo Francisco AM, Barner Lekdorf J, Kvist K, Buse JB; DEVOTE Study Group. Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia. 2018 Jan;61(1):48-57. doi: 10.1007/s00125-017-4423-z. Epub 2017 Sep 15.
- Pieber TR, Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pratley RE, Woo V, Heller S, Lange M, Brown-Frandsen K, Moses A, Barner Lekdorf J, Lehmann L, Kvist K, Buse JB; DEVOTE Study Group. DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. Diabetologia. 2018 Jan;61(1):58-65. doi: 10.1007/s00125-017-4422-0. Epub 2017 Sep 15.
- Pollock RF, Valentine WJ, Marso SP, Gundgaard J, Hallen N, Hansen LL, Tutkunkardas D, Buse JB; DEVOTE Study Group. DEVOTE 5: Evaluating the Short-Term Cost-Utility of Insulin Degludec Versus Insulin Glargine U100 in Basal-Bolus Regimens for Type 2 Diabetes in the UK. Diabetes Ther. 2018 Jun;9(3):1217-1232. doi: 10.1007/s13300-018-0430-4. Epub 2018 Apr 30.
- Theilgaard H, Mollerup I, Helmark IC, Endahl L, Hoskin S, Hvelplund A, Amby LK, Moses AC. Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events). Ther Innov Regul Sci. 2019 Mar;53(2):279-286. doi: 10.1177/2168479018776943. Epub 2018 May 24.
- Brown-Frandsen K, Emerson SS, McGuire DK, Pieber TR, Poulter NR, Pratley RE, Zinman B, Ranthe MF, Gron R, Lange M, Moses AC, Orsy P, Buse JB; DEVOTE Study Group. Lower rates of cardiovascular events and mortality associated with liraglutide use in patients treated with basal insulin: A DEVOTE subanalysis (DEVOTE 10). Diabetes Obes Metab. 2019 Jun;21(6):1437-1444. doi: 10.1111/dom.13677. Epub 2019 Apr 1.
- Pratley RE, Emerson SS, Franek E, Gilbert MP, Marso SP, McGuire DK, Pieber TR, Zinman B, Hansen CT, Hansen MV, Mark T, Moses AC, Buse JB; DEVOTE Study Group. Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes aged 65 years or older: Results from DEVOTE (DEVOTE 7). Diabetes Obes Metab. 2019 Jul;21(7):1625-1633. doi: 10.1111/dom.13699. Epub 2019 Apr 15.
- Klein KR, Franek E, Marso S, Pieber TR, Pratley RE, Gowda A, Kvist K, Buse JB. Hemoglobin glycation index, calculated from a single fasting glucose value, as a prediction tool for severe hypoglycemia and major adverse cardiovascular events in DEVOTE. BMJ Open Diabetes Res Care. 2021 Nov;9(2):e002339. doi: 10.1136/bmjdrc-2021-002339.
- Amod A, Buse JB, McGuire DK, Pieber TR, Pop-Busui R, Pratley RE, Zinman B, Hansen MB, Jia T, Mark T, Poulter NR; DEVOTE Study Group. Risk factors for kidney disorders in patients with type 2 diabetes at high cardiovascular risk: An exploratory analysis (DEVOTE 12). Diab Vasc Dis Res. 2020 Nov-Dec;17(6):1479164120970933. doi: 10.1177/1479164120970933.
- Heller S, Lingvay I, Marso SP, Philis-Tsimikas A, Pieber TR, Poulter NR, Pratley RE, Hachmann-Nielsen E, Kvist K, Lange M, Moses AC, Andresen MT, Buse JB; DEVOTE Study Group. Risk of severe hypoglycaemia and its impact in type 2 diabetes in DEVOTE. Diabetes Obes Metab. 2020 Dec;22(12):2241-2247. doi: 10.1111/dom.14049. Epub 2020 Jul 9.
- Pratley RE, Husain M, Lingvay I, Pieber TR, Mark T, Saevereid HA, Moller DV, Zinman B; DEVOTE Study Group. Heart failure with insulin degludec versus glargine U100 in patients with type 2 diabetes at high risk of cardiovascular disease: DEVOTE 14. Cardiovasc Diabetol. 2019 Nov 15;18(1):156. doi: 10.1186/s12933-019-0960-8.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
29 ottobre 2013
Completamento primario (Effettivo)
16 ottobre 2016
Completamento dello studio (Effettivo)
16 ottobre 2016
Date di iscrizione allo studio
Primo inviato
8 ottobre 2013
Primo inviato che soddisfa i criteri di controllo qualità
8 ottobre 2013
Primo Inserito (Stima)
10 ottobre 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 luglio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 luglio 2019
Ultimo verificato
1 luglio 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EX1250-4080
- 2013-002371-17 (Numero EudraCT)
- U1111-1141-7614 (Altro identificatore: WHO)
- JapicCTI-142464 (Identificatore di registro: JAPIC)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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