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 juillet 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
7637
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Eastern Cape
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Port Elizabeth, Eastern Cape, Afrique du Sud, 6045
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Port Elizabeth, Eastern Cape, Afrique du Sud, 6014
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Gauteng
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Johannesburg, Gauteng, Afrique du Sud, 2193
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Johannesburg, Gauteng, Afrique du Sud, 1818
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Johannesburg, Gauteng, Afrique du Sud, 2198
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Pretoria, Gauteng, Afrique du Sud, 0001
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Afrique du Sud, 4001
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Durban, KwaZulu-Natal, Afrique du Sud, 4092
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Umkomaas, KwaZulu-Natal, Afrique du Sud, 4170
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Mpumalanga
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Middleburg, Mpumalanga, Afrique du Sud, 1055
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North West
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Brits, North West, Afrique du Sud, 0250
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Western Cape
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Cape Town, Western Cape, Afrique du Sud, 7130
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Cape Town, Western Cape, Afrique du Sud, 7500
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Cape Town, Western Cape, Afrique du Sud, 7700
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Cape Town, Western Cape, Afrique du Sud, 7460
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Algiers, Algérie, 16000
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Constantine, Algérie, 25000
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Oran, Algérie, 31000
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Sidi Bel Abbes, Algérie, 22000
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Caba, Argentine, C1440AAD
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Cordoba, Argentine, 5000
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Mar del Plata, Argentine, B7600FZN
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Rosario, Argentine, S2000CUD
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Zarate, Argentine, B2800DGH
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Fortaleza, Brésil, 60430-350
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Porto Alegre, Brésil, 90035-170
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Ceara
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Fortaleza, Ceara, Brésil, 60115-282
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Distrito Federal
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Brasília, Distrito Federal, Brésil, 71625-009
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Goias
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Aparecida de Goiania, Goias, Brésil, 74935-530
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Para
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Belém, Para, Brésil, 66073-000
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Sao Paulo
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Mogi das Cruzes, Sao Paulo, Brésil, 08780-090
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São Paulo, Sao Paulo, Brésil, 05403-000
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São Paulo, Sao Paulo, Brésil, 01223-001
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São Paulo, Sao Paulo, Brésil, 01228-000
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São Paulo, Sao Paulo, Brésil, 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, Corée, République de, 10380
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Seoul, Corée, République de, 02841
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Seoul, Corée, République de, 03080
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Suwon-si, Gyeonggi-do, Corée, République de, 16247
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Bjelovar, Croatie, 43000
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Osijek, Croatie, 31 000
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Slavonski Brod, Croatie, 35 000
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Zagreb, Croatie, 10 000
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Zagreb, Croatie, 10000
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Granada, Espagne, 18012
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Granada, Espagne, 18003
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Madrid, Espagne, 28046
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Málaga, Espagne, 29006
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Sevilla, Espagne, 41009
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Valencia, Espagne, 46014
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Valencia, Espagne, 46015
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Ekaterinburg, Fédération Russe, 620102
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Kemerovo, Fédération Russe, 650002
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Kirov, Fédération Russe, 610014
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Krasnodar, Fédération Russe, 350012
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Krasnodar, Fédération Russe, 350086
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Moscow, Fédération Russe, 123423
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Moscow, Fédération Russe, 111539
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Nizhny Novgorod, Fédération Russe, 603018
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Rostov-on-Don, Fédération Russe, 344068
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Saint-Petersburg, Fédération Russe, 194356
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Saint-Petersburg, Fédération Russe, 195213
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Saint-Petersburg, Fédération Russe, 191119
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Saratov, Fédération Russe, 410053
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Saratov, Fédération Russe, 410031
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St. Petersburg, Fédération Russe, 194354
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St. Petersburg, Fédération Russe, 196084
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Syktyvkar, Fédération Russe, 167981
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Tumen, Fédération Russe, 625023
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Tver, Fédération Russe, 170036
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Ulianovsk, Fédération Russe, 432063
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Volgograd, Fédération Russe, 400131
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Yaroslavl, Fédération Russe, 150010
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Athens, Grèce, GR-17562
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Athens, Grèce, GR-11527
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Athens, Grèce, GR-115 27
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Athens, Grèce, GR-10552
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Thessaloniki, Grèce, GR-57001
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Thessaloniki, Grèce, GR-54642
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Ludhiana, Inde, 141001
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New Delhi, Inde, 110001
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Inde, 500034
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Hyderbad, Andhra Pradesh, Inde, 500 012
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Gujarat
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Ahmedabad, Gujarat, Inde, 380006
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Ahmedabad, Gujarat, Inde, 380052
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Ahmedabad, Gujarat, Inde, 380007
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Ahmedabad, Gujarat, Inde, 380016
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Haryana
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Gurgaon, Haryana, Inde, 122001
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Karnataka
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Bangalore, Karnataka, Inde, 560034
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Bangalore, Karnataka, Inde, 560 017
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Kerala
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Kozhikode, Kerala, Inde, 673017
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Madhya Pradesh
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Indore, Madhya Pradesh, Inde, 452010
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Maharashtra
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Goa, Maharashtra, Inde, 403 202
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Mumbai, Maharashtra, Inde, 400008
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Mumbai, Maharashtra, Inde, 400012
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Mumbai, Maharashtra, Inde, 400022
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Mumbai, Maharashtra, Inde, 400010
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Mumbai, Maharashtra, Inde, 400007
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Pune, Maharashtra, Inde, 411001
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Pune, Maharashtra, Inde, 411040
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New Delhi
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New Dehli, New Delhi, Inde, 110029
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Orissa
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Bhubaneswar, Orissa, Inde, 751005
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Punjab
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Mohali, Punjab, Inde, 160062
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Tamil Nadu
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Chennai, Tamil Nadu, Inde, 600086
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Chennai, Tamil Nadu, Inde, 600031
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Coimbatore, Tamil Nadu, Inde, 641018
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Inde, 226014
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West Bengal
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Kolkata, West Bengal, Inde, 700020
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Kolkata, West Bengal, Inde, 700054
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Bari, Italie, 70124
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Bergamo, Italie, 24127
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Catanzaro, Italie, 88100
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Chieti, Italie, 66100
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Milano, Italie, 20122
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Milano, Italie, 20162
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Milano (MI), Italie, 20132
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Olbia, Italie, 07026
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Padova, Italie, 35143
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Palermo, Italie, 90127
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Ravenna, Italie, 48121
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Roma, Italie, 00161
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Roma, Italie, 00133
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Sesto San Giovanni (MI), Italie, 20099
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Chuo-ku, Tokyo, Japon, 103-0002
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Kanagawa, Japon, 235-0045
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Kumamoto, Japon, 862-0976
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Miyazaki, Japon, 880-0034
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Nagano, Japon, 390-8621
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Ota-ku, Japon, 144 0035
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Ota-ku, Tokyo, Japon, 1430015
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Shinjuku-ku, Tokyo, Japon, 162-8655
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Alor Setar, Malaisie, 05460
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Kota Samarahan, Malaisie, 94300
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Kuala Lumpur, Malaisie, 59100
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Kuantan, Malaisie, 25100
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Melaka, Malaisie, 75400
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Serdang, Malaisie, 43000
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Seremban, Malaisie, 70300
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Aguascalientes, Mexique, 20230
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Chihuahua, Mexique, 31200
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San Luis Potosi, Mexique, 78200
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Jalisco
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Guadalajara, Jalisco, Mexique, 44600
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Guadalajara, Jalisco, Mexique, 44130
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Guadalajara, Jalisco, Mexique, 44650
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Guadalajara, Jalisco, Mexique, 44670
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Guadalajara, Jalisco, Mexique, 44150
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Morelos
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Cuernavaca, Morelos, Mexique, 62250
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México, D.F.
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Distrito Federal, México, D.F., Mexique, 14080
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Bytom, Pologne, 41-902
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Gdansk, Pologne, 80-546
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Krakow, Pologne, 31-455
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Oswiecim, Pologne, 32-600
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Poznan, Pologne, 60-589
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Szczecin, Pologne, 70-506
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Warszawa, Pologne, 02-507
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Zamosc, Pologne, 22-400
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Alba
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Alba Iulia, Alba, Roumanie, 510053
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Maramures
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Baia Mare, Maramures, Roumanie, 430222
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Mures
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Targu Mures, Mures, Roumanie, 540142
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Prahova
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Ploiesti, Prahova, Roumanie, 100163
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Bristol, Royaume-Uni, BS10 5NB
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Dundee, Royaume-Uni, DD1 9SY
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Edinburgh, Royaume-Uni, EH4 2XU
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Guildford, Royaume-Uni, GU2 7XX
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Norwich, Royaume-Uni, NR4 7TJ
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Nuneaton, Royaume-Uni, CV10 7DJ
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Stevenage, Royaume-Uni, SG1 4AB
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Wolverhampton, Royaume-Uni, WV10 0QP
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Bangkok, Thaïlande, 10400
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Bangkok, Thaïlande, 10330
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Bangkoknoi, Bangkok, Thaïlande, 10700
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Chiang Mai, Thaïlande, 50200
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Nakhon Ratchasima, Thaïlande, 30000
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Alabama
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Birmingham, Alabama, États-Unis, 35294
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Birmingham, Alabama, États-Unis, 35216
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Montgomery, Alabama, États-Unis, 36106
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Montgomery, Alabama, États-Unis, 36109
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Arizona
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Gilbert, Arizona, États-Unis, 85295
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Glendale, Arizona, États-Unis, 85308
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Litchfield Park, Arizona, États-Unis, 85340
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Phoenix, Arizona, États-Unis, 85050
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Tucson, Arizona, États-Unis, 85714
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Tucson, Arizona, États-Unis, 85704
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Tucson, Arizona, États-Unis, 85723
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
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Little Rock, Arkansas, États-Unis, 72205-5446
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Searcy, Arkansas, États-Unis, 72143
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California
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Chula Vista, California, États-Unis, 91910
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Concord, California, États-Unis, 94520
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Downey, California, États-Unis, 90242
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Duarte, California, États-Unis, 91010
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Encino, California, États-Unis, 91436
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Fresno, California, États-Unis, 93720
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Greenbrae, California, États-Unis, 94904
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Huntington Beach, California, États-Unis, 92648
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Inglewood, California, États-Unis, 90301
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La Jolla, California, États-Unis, 92037
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La Mesa, California, États-Unis, 91942
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Lancaster, California, États-Unis, 93534
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Long Beach, California, États-Unis, 90822
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Los Alamitos, California, États-Unis, 90720
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Mission Hills, California, États-Unis, 91345
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Montclair, California, États-Unis, 91763
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Monterey, California, États-Unis, 93940
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North Hollywood, California, États-Unis, 91606
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Palm Springs, California, États-Unis, 92262
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Poway, California, États-Unis, 92064
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San Diego, California, États-Unis, 92111
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San Diego, California, États-Unis, 92120
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San Ramon, California, États-Unis, 94583
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Santa Ana, California, États-Unis, 92704
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Sherman Oaks, California, États-Unis, 91403
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Thousand Oaks, California, États-Unis, 91360
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Tustin, California, États-Unis, 92780
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Ventura, California, États-Unis, 93003
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Vista, California, États-Unis, 92083
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Westminster, California, États-Unis, 92683
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Colorado
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Colorado Springs, Colorado, États-Unis, 80909
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Denver, Colorado, États-Unis, 80220
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Denver, Colorado, États-Unis, 80246
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Golden, Colorado, États-Unis, 80401
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Connecticut
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Danbury, Connecticut, États-Unis, 06810
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Norwalk, Connecticut, États-Unis, 06851
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Waterbury, Connecticut, États-Unis, 06708
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Florida
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Boca Raton, Florida, États-Unis, 33433
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Boynton Beach, Florida, États-Unis, 33472
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Bradenton, Florida, États-Unis, 34201
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Brandon, Florida, États-Unis, 33511
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Clearwater, Florida, États-Unis, 33756
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Cooper City, Florida, États-Unis, 33024
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Fleming Island, Florida, États-Unis, 32003
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Fort Lauderdale, Florida, États-Unis, 33316
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Gainesville, Florida, États-Unis, 32610
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Green Cove Springs, Florida, États-Unis, 32043
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Hialeah, Florida, États-Unis, 33012
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Jacksonville, Florida, États-Unis, 32216
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Jacksonville, Florida, États-Unis, 32207
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Miami, Florida, États-Unis, 33135
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Miami, Florida, États-Unis, 33136
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Miami, Florida, États-Unis, 33183
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Miami, Florida, États-Unis, 33155
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Miami, Florida, États-Unis, 33165
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Naples, Florida, États-Unis, 34119
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New Port Richey, Florida, États-Unis, 34652
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Orlando, Florida, États-Unis, 32806
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Panama City, Florida, États-Unis, 32401
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Ponte Vedra, Florida, États-Unis, 32081
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Port Charlotte, Florida, États-Unis, 33952
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Port Orange, Florida, États-Unis, 32127
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South Miami, Florida, États-Unis, 33143
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Tampa, Florida, États-Unis, 33624
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Tampa, Florida, États-Unis, 33619
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Georgia
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Atlanta, Georgia, États-Unis, 30339
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Decatur, Georgia, États-Unis, 30033
- Novo Nordisk Investigational Site
-
Dunwoody, Georgia, États-Unis, 30338
- Novo Nordisk Investigational Site
-
Lawrenceville, Georgia, États-Unis, 30046
- Novo Nordisk Investigational Site
-
Roswell, Georgia, États-Unis, 30076
- Novo Nordisk Investigational Site
-
Savannah, Georgia, États-Unis, 31406
- Novo Nordisk Investigational Site
-
-
Hawaii
-
Honolulu, Hawaii, États-Unis, 96814
- Novo Nordisk Investigational Site
-
-
Idaho
-
Idaho Falls, Idaho, États-Unis, 83404-7596
- Novo Nordisk Investigational Site
-
-
Illinois
-
Addison, Illinois, États-Unis, 60101
- Novo Nordisk Investigational Site
-
Champaign, Illinois, États-Unis, 61821
- Novo Nordisk Investigational Site
-
Chicago, Illinois, États-Unis, 60607
- Novo Nordisk Investigational Site
-
Chicago, Illinois, États-Unis, 60616
- Novo Nordisk Investigational Site
-
Crystal Lake, Illinois, États-Unis, 60012
- Novo Nordisk Investigational Site
-
Gurnee, Illinois, États-Unis, 60031
- Novo Nordisk Investigational Site
-
Hines, Illinois, États-Unis, 60141
- Novo Nordisk Investigational Site
-
Springfield, Illinois, États-Unis, 62711
- Novo Nordisk Investigational Site
-
Springfield, Illinois, États-Unis, 62702
- Novo Nordisk Investigational Site
-
-
Indiana
-
Brownsburg, Indiana, États-Unis, 46112
- Novo Nordisk Investigational Site
-
Evansville, Indiana, États-Unis, 47714
- Novo Nordisk Investigational Site
-
Franklin, Indiana, États-Unis, 46131
- Novo Nordisk Investigational Site
-
Greenfield, Indiana, États-Unis, 46140
- Novo Nordisk Investigational Site
-
Indianapolis, Indiana, États-Unis, 46254
- Novo Nordisk Investigational Site
-
Michigan City, Indiana, États-Unis, 46360
- Novo Nordisk Investigational Site
-
Muncie, Indiana, États-Unis, 47304
- Novo Nordisk Investigational Site
-
-
Iowa
-
Council Bluffs, Iowa, États-Unis, 51501
- Novo Nordisk Investigational Site
-
-
Kansas
-
Wichita, Kansas, États-Unis, 67205
- Novo Nordisk Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40503
- Novo Nordisk Investigational Site
-
Lexington, Kentucky, États-Unis, 40502
- Novo Nordisk Investigational Site
-
Louisville, Kentucky, États-Unis, 40213
- Novo Nordisk Investigational Site
-
Louisville, Kentucky, États-Unis, 40206
- Novo Nordisk Investigational Site
-
Madisonville, Kentucky, États-Unis, 42431
- Novo Nordisk Investigational Site
-
-
Louisiana
-
Monroe, Louisiana, États-Unis, 71203
- Novo Nordisk Investigational Site
-
New Orleans, Louisiana, États-Unis, 70119
- Novo Nordisk Investigational Site
-
Shreveport, Louisiana, États-Unis, 71103
- Novo Nordisk Investigational Site
-
Slidell, Louisiana, États-Unis, 70461-4231
- Novo Nordisk Investigational Site
-
-
Maine
-
Bangor, Maine, États-Unis, 04401
- Novo Nordisk Investigational Site
-
-
Maryland
-
Hyattsville, Maryland, États-Unis, 20782
- Novo Nordisk Investigational Site
-
Rockville, Maryland, États-Unis, 20852
- Novo Nordisk Investigational Site
-
-
Massachusetts
-
Watertown, Massachusetts, États-Unis, 02472
- Novo Nordisk Investigational Site
-
Worcester, Massachusetts, États-Unis, 01655
- Novo Nordisk Investigational Site
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48106
- Novo Nordisk Investigational Site
-
Ann Arbor, Michigan, États-Unis, 48105
- Novo Nordisk Investigational Site
-
Buckley, Michigan, États-Unis, 49620
- Novo Nordisk Investigational Site
-
Detroit, Michigan, États-Unis, 48201
- Novo Nordisk Investigational Site
-
Detroit, Michigan, États-Unis, 48202
- Novo Nordisk Investigational Site
-
Kalamazoo, Michigan, États-Unis, 49009
- Novo Nordisk Investigational Site
-
Livonia, Michigan, États-Unis, 48152
- Novo Nordisk Investigational Site
-
Troy, Michigan, États-Unis, 48098
- Novo Nordisk Investigational Site
-
-
Mississippi
-
Olive Branch, Mississippi, États-Unis, 38654
- Novo Nordisk Investigational Site
-
-
Missouri
-
Hazelwood, Missouri, États-Unis, 63042
- Novo Nordisk Investigational Site
-
Jefferson City, Missouri, États-Unis, 65109
- Novo Nordisk Investigational Site
-
Kansas City, Missouri, États-Unis, 64111
- Novo Nordisk Investigational Site
-
-
Montana
-
Billings, Montana, États-Unis, 59101
- Novo Nordisk Investigational Site
-
Kalispell, Montana, États-Unis, 59901
- Novo Nordisk Investigational Site
-
-
Nebraska
-
Elkhorn, Nebraska, États-Unis, 68022
- Novo Nordisk Investigational Site
-
Fremont, Nebraska, États-Unis, 68025
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, États-Unis, 68114
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, États-Unis, 68105
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, États-Unis, 68124
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, États-Unis, 68144
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, États-Unis, 68198-4120
- Novo Nordisk Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89148
- Novo Nordisk Investigational Site
-
Las Vegas, Nevada, États-Unis, 89128
- Novo Nordisk Investigational Site
-
Las Vegas, Nevada, États-Unis, 89120
- Novo Nordisk Investigational Site
-
-
New Hampshire
-
Nashua, New Hampshire, États-Unis, 03063
- Novo Nordisk Investigational Site
-
-
New Jersey
-
East Brunswick, New Jersey, États-Unis, 08816
- Novo Nordisk Investigational Site
-
Hoboken, New Jersey, États-Unis, 07030
- Novo Nordisk Investigational Site
-
-
New York
-
Albany, New York, États-Unis, 12206
- Novo Nordisk Investigational Site
-
Lake Success, New York, États-Unis, 11042
- Novo Nordisk Investigational Site
-
Mineola, New York, États-Unis, 11501
- Novo Nordisk Investigational Site
-
New Windsor, New York, États-Unis, 12553
- Novo Nordisk Investigational Site
-
New York, New York, États-Unis, 10029
- Novo Nordisk Investigational Site
-
North Massapequa, New York, États-Unis, 11758-1802
- Novo Nordisk Investigational Site
-
Northport, New York, États-Unis, 11768
- Novo Nordisk Investigational Site
-
Rochester, New York, États-Unis, 14607
- Novo Nordisk Investigational Site
-
West Seneca, New York, États-Unis, 14224
- Novo Nordisk Investigational Site
-
Westfield, New York, États-Unis, 14787
- Novo Nordisk Investigational Site
-
-
North Carolina
-
Asheville, North Carolina, États-Unis, 28803
- Novo Nordisk Investigational Site
-
Asheville, North Carolina, États-Unis, 28801
- Novo Nordisk Investigational Site
-
Burlington, North Carolina, États-Unis, 27215
- Novo Nordisk Investigational Site
-
Cary, North Carolina, États-Unis, 27518
- Novo Nordisk Investigational Site
-
Chapel Hill, North Carolina, États-Unis, 27517
- Novo Nordisk Investigational Site
-
Charlotte, North Carolina, États-Unis, 28209
- Novo Nordisk Investigational Site
-
Greenville, North Carolina, États-Unis, 27834
- Novo Nordisk Investigational Site
-
Lexington, North Carolina, États-Unis, 27292
- Novo Nordisk Investigational Site
-
Morehead City, North Carolina, États-Unis, 28557
- Novo Nordisk Investigational Site
-
New Bern, North Carolina, États-Unis, 28562
- Novo Nordisk Investigational Site
-
Statesville, North Carolina, États-Unis, 28625
- Novo Nordisk Investigational Site
-
Whiteville, North Carolina, États-Unis, 28472
- Novo Nordisk Investigational Site
-
Wilmington, North Carolina, États-Unis, 28401
- Novo Nordisk Investigational Site
-
Winston-Salem, North Carolina, États-Unis, 27103
- Novo Nordisk Investigational Site
-
-
North Dakota
-
Fargo, North Dakota, États-Unis, 58104
- Novo Nordisk Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, États-Unis, 45236
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, États-Unis, 44195
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, États-Unis, 44106-1702
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, États-Unis, 44121
- Novo Nordisk Investigational Site
-
Columbus, Ohio, États-Unis, 43235
- Novo Nordisk Investigational Site
-
Delaware, Ohio, États-Unis, 43015
- Novo Nordisk Investigational Site
-
Franklin, Ohio, États-Unis, 45005
- Novo Nordisk Investigational Site
-
Maumee, Ohio, États-Unis, 43537
- Novo Nordisk Investigational Site
-
Mentor, Ohio, États-Unis, 44060
- Novo Nordisk Investigational Site
-
Perrysburg, Ohio, États-Unis, 43551
- Novo Nordisk Investigational Site
-
-
Oklahoma
-
Norman, Oklahoma, États-Unis, 73069
- Novo Nordisk Investigational Site
-
Oklahoma City, Oklahoma, États-Unis, 73104
- Novo Nordisk Investigational Site
-
-
Oregon
-
Portland, Oregon, États-Unis, 97239-3098
- Novo Nordisk Investigational Site
-
-
Pennsylvania
-
Altoona, Pennsylvania, États-Unis, 16602
- Novo Nordisk Investigational Site
-
Beaver, Pennsylvania, États-Unis, 15009
- Novo Nordisk Investigational Site
-
Danville, Pennsylvania, États-Unis, 17822
- Novo Nordisk Investigational Site
-
Hermitage, Pennsylvania, États-Unis, 16148
- Novo Nordisk Investigational Site
-
Philadelphia, Pennsylvania, États-Unis, 19107
- Novo Nordisk Investigational Site
-
Philadelphia, Pennsylvania, États-Unis, 19114
- Novo Nordisk Investigational Site
-
Pittsburgh, Pennsylvania, États-Unis, 15243
- Novo Nordisk Investigational Site
-
Pittsburgh, Pennsylvania, États-Unis, 15212
- Novo Nordisk Investigational Site
-
Smithfield, Pennsylvania, États-Unis, 15478
- Novo Nordisk Investigational Site
-
Uniontown, Pennsylvania, États-Unis, 15401
- Novo Nordisk Investigational Site
-
Upper Darby, Pennsylvania, États-Unis, 19082
- Novo Nordisk Investigational Site
-
Wilkes-Barre, Pennsylvania, États-Unis, 18702
- Novo Nordisk Investigational Site
-
-
South Carolina
-
Anderson, South Carolina, États-Unis, 29621
- Novo Nordisk Investigational Site
-
Greer, South Carolina, États-Unis, 29651
- Novo Nordisk Investigational Site
-
Moncks Corner, South Carolina, États-Unis, 29461
- Novo Nordisk Investigational Site
-
Murrells Inlet, South Carolina, États-Unis, 29576
- Novo Nordisk Investigational Site
-
Myrtle Beach, South Carolina, États-Unis, 29572
- Novo Nordisk Investigational Site
-
Orangeburg, South Carolina, États-Unis, 29118
- Novo Nordisk Investigational Site
-
Spartanburg, South Carolina, États-Unis, 29303
- Novo Nordisk Investigational Site
-
-
Tennessee
-
Chattanooga, Tennessee, États-Unis, 37404
- Novo Nordisk Investigational Site
-
Chattanooga, Tennessee, États-Unis, 37411
- Novo Nordisk Investigational Site
-
Chattanooga, Tennessee, États-Unis, 37404-1192
- Novo Nordisk Investigational Site
-
Kingsport, Tennessee, États-Unis, 37660
- Novo Nordisk Investigational Site
-
Knoxville, Tennessee, États-Unis, 37938
- Novo Nordisk Investigational Site
-
Memphis, Tennessee, États-Unis, 38119
- Novo Nordisk Investigational Site
-
Memphis, Tennessee, États-Unis, 38163
- Novo Nordisk Investigational Site
-
Nashville, Tennessee, États-Unis, 37212
- Novo Nordisk Investigational Site
-
Nashville, Tennessee, États-Unis, 37203
- Novo Nordisk Investigational Site
-
Nashville, Tennessee, États-Unis, 37208
- Novo Nordisk Investigational Site
-
Tullahoma, Tennessee, États-Unis, 37388
- Novo Nordisk Investigational Site
-
-
Texas
-
Arlington, Texas, États-Unis, 76012
- Novo Nordisk Investigational Site
-
Austin, Texas, États-Unis, 78731
- Novo Nordisk Investigational Site
-
Austin, Texas, États-Unis, 78749
- Novo Nordisk Investigational Site
-
Austin, Texas, États-Unis, 78705
- Novo Nordisk Investigational Site
-
Carrollton, Texas, États-Unis, 75010
- Novo Nordisk Investigational Site
-
Carrollton, Texas, États-Unis, 75007
- Novo Nordisk Investigational Site
-
Corpus Christi, Texas, États-Unis, 78404
- Novo Nordisk Investigational Site
-
Dallas, Texas, États-Unis, 75230
- Novo Nordisk Investigational Site
-
Dallas, Texas, États-Unis, 75390-9302
- Novo Nordisk Investigational Site
-
Dallas, Texas, États-Unis, 75231
- Novo Nordisk Investigational Site
-
Dallas, Texas, États-Unis, 75246
- Novo Nordisk Investigational Site
-
Fort Worth, Texas, États-Unis, 76117
- Novo Nordisk Investigational Site
-
Fort Worth, Texas, États-Unis, 76132
- Novo Nordisk Investigational Site
-
Houston, Texas, États-Unis, 77024
- Novo Nordisk Investigational Site
-
Houston, Texas, États-Unis, 77061
- Novo Nordisk Investigational Site
-
Houston, Texas, États-Unis, 77008
- Novo Nordisk Investigational Site
-
Houston, Texas, États-Unis, 77070
- Novo Nordisk Investigational Site
-
Houston, Texas, États-Unis, 77099
- Novo Nordisk Investigational Site
-
Houston, Texas, États-Unis, 77060
- Novo Nordisk Investigational Site
-
Houston, Texas, États-Unis, 77029
- Novo Nordisk Investigational Site
-
Houston, Texas, États-Unis, 77093
- Novo Nordisk Investigational Site
-
Humble, Texas, États-Unis, 77338
- Novo Nordisk Investigational Site
-
Hurst, Texas, États-Unis, 76054
- Novo Nordisk Investigational Site
-
Irving, Texas, États-Unis, 75039
- Novo Nordisk Investigational Site
-
Lewisville, Texas, États-Unis, 75067
- Novo Nordisk Investigational Site
-
Longview, Texas, États-Unis, 75605
- Novo Nordisk Investigational Site
-
Lubbock, Texas, États-Unis, 79423
- Novo Nordisk Investigational Site
-
Midland, Texas, États-Unis, 79707
- Novo Nordisk Investigational Site
-
Odessa, Texas, États-Unis, 79761
- Novo Nordisk Investigational Site
-
Pearland, Texas, États-Unis, 77584
- Novo Nordisk Investigational Site
-
Richardson, Texas, États-Unis, 75080
- Novo Nordisk Investigational Site
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Round Rock, Texas, États-Unis, 78681
- Novo Nordisk Investigational Site
-
San Antonio, Texas, États-Unis, 78229
- Novo Nordisk Investigational Site
-
San Antonio, Texas, États-Unis, 78215
- Novo Nordisk Investigational Site
-
San Antonio, Texas, États-Unis, 78228-6205
- Novo Nordisk Investigational Site
-
San Antonio, Texas, États-Unis, 78258
- Novo Nordisk Investigational Site
-
Splendora, Texas, États-Unis, 77372
- Novo Nordisk Investigational Site
-
Sugar Land, Texas, États-Unis, 77478
- Novo Nordisk Investigational Site
-
Sugar Land, Texas, États-Unis, 77479
- Novo Nordisk Investigational Site
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Waco, Texas, États-Unis, 76710
- Novo Nordisk Investigational Site
-
-
Utah
-
Salt Lake City, Utah, États-Unis, 84102
- Novo Nordisk Investigational Site
-
Salt Lake City, Utah, États-Unis, 84132
- Novo Nordisk Investigational Site
-
-
Vermont
-
Bennington, Vermont, États-Unis, 05201
- Novo Nordisk Investigational Site
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South Burlington, Vermont, États-Unis, 05403
- Novo Nordisk Investigational Site
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-
Virginia
-
Midlothian, Virginia, États-Unis, 23114
- Novo Nordisk Investigational Site
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Norfolk, Virginia, États-Unis, 23510
- Novo Nordisk Investigational Site
-
Richmond, Virginia, États-Unis, 23249
- Novo Nordisk Investigational Site
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Winchester, Virginia, États-Unis, 22601-3834
- Novo Nordisk Investigational Site
-
-
Washington
-
Richland, Washington, États-Unis, 99352
- Novo Nordisk Investigational Site
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Spokane, Washington, États-Unis, 99201
- Novo Nordisk Investigational Site
-
-
Wisconsin
-
Kenosha, Wisconsin, États-Unis, 53144
- Novo Nordisk Investigational Site
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Milwaukee, Wisconsin, États-Unis, 53209
- Novo Nordisk Investigational Site
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Milwaukee, Wisconsin, États-Unis, 53295
- Novo Nordisk Investigational Site
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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)
|
|
Comparateur actif: 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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of EAC-confirmed Severe Hypoglycaemic Episodes
Délai: 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)
Délai: 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)
Délai: Randomisation to 24 months
|
Mean change in HbA1c from week 0 to month 24.
|
Randomisation to 24 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
29 octobre 2013
Achèvement primaire (Réel)
16 octobre 2016
Achèvement de l'étude (Réel)
16 octobre 2016
Dates d'inscription aux études
Première soumission
8 octobre 2013
Première soumission répondant aux critères de contrôle qualité
8 octobre 2013
Première publication (Estimation)
10 octobre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juillet 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juillet 2019
Dernière vérification
1 juillet 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EX1250-4080
- 2013-002371-17 (Numéro EudraCT)
- U1111-1141-7614 (Autre identifiant: WHO)
- JapicCTI-142464 (Identificateur de registre: JAPIC)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .