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 juli 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
7637
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Algiers, Algerije, 16000
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Constantine, Algerije, 25000
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Oran, Algerije, 31000
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Sidi Bel Abbes, Algerije, 22000
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Caba, Argentinië, C1440AAD
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Cordoba, Argentinië, 5000
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Mar del Plata, Argentinië, B7600FZN
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Rosario, Argentinië, S2000CUD
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Zarate, Argentinië, B2800DGH
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Fortaleza, Brazilië, 60430-350
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Porto Alegre, Brazilië, 90035-170
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Ceara
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Fortaleza, Ceara, Brazilië, 60115-282
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Distrito Federal
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Brasília, Distrito Federal, Brazilië, 71625-009
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Goias
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Aparecida de Goiania, Goias, Brazilië, 74935-530
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Para
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Belém, Para, Brazilië, 66073-000
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Sao Paulo
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Mogi das Cruzes, Sao Paulo, Brazilië, 08780-090
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São Paulo, Sao Paulo, Brazilië, 05403-000
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São Paulo, Sao Paulo, Brazilië, 01223-001
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São Paulo, Sao Paulo, Brazilië, 01228-000
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São Paulo, Sao Paulo, Brazilië, 01228-200
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Alberta
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Manitoba
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Ontario
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Chatham, Ontario, Canada, N7L 1C1
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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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Athens, Griekenland, GR-17562
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Athens, Griekenland, GR-11527
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Athens, Griekenland, GR-115 27
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Athens, Griekenland, GR-10552
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Thessaloniki, Griekenland, GR-57001
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Thessaloniki, Griekenland, GR-54642
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Ludhiana, Indië, 141001
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New Delhi, Indië, 110001
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indië, 500034
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Hyderbad, Andhra Pradesh, Indië, 500 012
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Gujarat
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Ahmedabad, Gujarat, Indië, 380006
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Ahmedabad, Gujarat, Indië, 380052
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Ahmedabad, Gujarat, Indië, 380007
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Ahmedabad, Gujarat, Indië, 380016
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Haryana
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Gurgaon, Haryana, Indië, 122001
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Karnataka
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Bangalore, Karnataka, Indië, 560034
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Bangalore, Karnataka, Indië, 560 017
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Kerala
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Kozhikode, Kerala, Indië, 673017
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Madhya Pradesh
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Indore, Madhya Pradesh, Indië, 452010
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Maharashtra
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Goa, Maharashtra, Indië, 403 202
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Mumbai, Maharashtra, Indië, 400008
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Mumbai, Maharashtra, Indië, 400012
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Mumbai, Maharashtra, Indië, 400022
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Mumbai, Maharashtra, Indië, 400010
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Mumbai, Maharashtra, Indië, 400007
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Pune, Maharashtra, Indië, 411001
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Pune, Maharashtra, Indië, 411040
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New Delhi
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New Dehli, New Delhi, Indië, 110029
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Orissa
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Bhubaneswar, Orissa, Indië, 751005
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Punjab
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Mohali, Punjab, Indië, 160062
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Tamil Nadu
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Chennai, Tamil Nadu, Indië, 600086
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Chennai, Tamil Nadu, Indië, 600031
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Coimbatore, Tamil Nadu, Indië, 641018
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Indië, 226014
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West Bengal
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Kolkata, West Bengal, Indië, 700020
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Kolkata, West Bengal, Indië, 700054
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Bari, Italië, 70124
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Bergamo, Italië, 24127
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Catanzaro, Italië, 88100
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Chieti, Italië, 66100
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Milano, Italië, 20122
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Milano, Italië, 20162
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Milano (MI), Italië, 20132
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Olbia, Italië, 07026
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Padova, Italië, 35143
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Palermo, Italië, 90127
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Ravenna, Italië, 48121
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Roma, Italië, 00161
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Roma, Italië, 00133
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Sesto San Giovanni (MI), Italië, 20099
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Chuo-ku, Tokyo, Japan, 103-0002
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Kanagawa, Japan, 235-0045
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Kumamoto, Japan, 862-0976
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Miyazaki, Japan, 880-0034
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Nagano, Japan, 390-8621
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Ota-ku, Japan, 144 0035
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Ota-ku, Tokyo, Japan, 1430015
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Shinjuku-ku, Tokyo, Japan, 162-8655
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Goyang, Korea, republiek van, 10380
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Seoul, Korea, republiek van, 02841
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Seoul, Korea, republiek van, 03080
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Suwon-si, Gyeonggi-do, Korea, republiek van, 16247
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Bjelovar, Kroatië, 43000
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Osijek, Kroatië, 31 000
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Slavonski Brod, Kroatië, 35 000
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Zagreb, Kroatië, 10 000
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Zagreb, Kroatië, 10000
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Alor Setar, Maleisië, 05460
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Kota Samarahan, Maleisië, 94300
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Kuala Lumpur, Maleisië, 59100
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Kuantan, Maleisië, 25100
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Melaka, Maleisië, 75400
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Serdang, Maleisië, 43000
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Seremban, Maleisië, 70300
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Aguascalientes, Mexico, 20230
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Chihuahua, Mexico, 31200
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San Luis Potosi, Mexico, 78200
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Jalisco
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Guadalajara, Jalisco, Mexico, 44600
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Guadalajara, Jalisco, Mexico, 44130
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Guadalajara, Jalisco, Mexico, 44650
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Guadalajara, Jalisco, Mexico, 44670
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Guadalajara, Jalisco, Mexico, 44150
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Morelos
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Cuernavaca, Morelos, Mexico, 62250
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México, D.F.
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Distrito Federal, México, D.F., Mexico, 14080
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Bytom, Polen, 41-902
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Gdansk, Polen, 80-546
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Krakow, Polen, 31-455
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Oswiecim, Polen, 32-600
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Poznan, Polen, 60-589
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Szczecin, Polen, 70-506
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Warszawa, Polen, 02-507
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Zamosc, Polen, 22-400
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Alba
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Alba Iulia, Alba, Roemenië, 510053
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Maramures
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Baia Mare, Maramures, Roemenië, 430222
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Mures
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Targu Mures, Mures, Roemenië, 540142
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Prahova
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Ploiesti, Prahova, Roemenië, 100163
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Ekaterinburg, Russische Federatie, 620102
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Kemerovo, Russische Federatie, 650002
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Kirov, Russische Federatie, 610014
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Krasnodar, Russische Federatie, 350012
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Krasnodar, Russische Federatie, 350086
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Moscow, Russische Federatie, 123423
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Moscow, Russische Federatie, 111539
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Nizhny Novgorod, Russische Federatie, 603018
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Rostov-on-Don, Russische Federatie, 344068
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Saint-Petersburg, Russische Federatie, 194356
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Saint-Petersburg, Russische Federatie, 195213
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Saint-Petersburg, Russische Federatie, 191119
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Saratov, Russische Federatie, 410053
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Saratov, Russische Federatie, 410031
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St. Petersburg, Russische Federatie, 194354
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St. Petersburg, Russische Federatie, 196084
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Syktyvkar, Russische Federatie, 167981
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Tumen, Russische Federatie, 625023
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Tver, Russische Federatie, 170036
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Ulianovsk, Russische Federatie, 432063
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Volgograd, Russische Federatie, 400131
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Yaroslavl, Russische Federatie, 150010
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Granada, Spanje, 18012
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Granada, Spanje, 18003
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Madrid, Spanje, 28046
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Málaga, Spanje, 29006
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Sevilla, Spanje, 41009
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Valencia, Spanje, 46014
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Valencia, Spanje, 46015
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10330
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Bangkoknoi, Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50200
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Nakhon Ratchasima, Thailand, 30000
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Bristol, Verenigd Koninkrijk, BS10 5NB
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Dundee, Verenigd Koninkrijk, DD1 9SY
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Edinburgh, Verenigd Koninkrijk, EH4 2XU
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Guildford, Verenigd Koninkrijk, GU2 7XX
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Norwich, Verenigd Koninkrijk, NR4 7TJ
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Nuneaton, Verenigd Koninkrijk, CV10 7DJ
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Stevenage, Verenigd Koninkrijk, SG1 4AB
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Wolverhampton, Verenigd Koninkrijk, WV10 0QP
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294
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Birmingham, Alabama, Verenigde Staten, 35216
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Montgomery, Alabama, Verenigde Staten, 36106
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Montgomery, Alabama, Verenigde Staten, 36109
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Arizona
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Gilbert, Arizona, Verenigde Staten, 85295
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Glendale, Arizona, Verenigde Staten, 85308
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Litchfield Park, Arizona, Verenigde Staten, 85340
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Phoenix, Arizona, Verenigde Staten, 85050
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Tucson, Arizona, Verenigde Staten, 85714
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Tucson, Arizona, Verenigde Staten, 85704
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Tucson, Arizona, Verenigde Staten, 85723
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
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Little Rock, Arkansas, Verenigde Staten, 72205-5446
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Searcy, Arkansas, Verenigde Staten, 72143
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California
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Chula Vista, California, Verenigde Staten, 91910
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Concord, California, Verenigde Staten, 94520
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Downey, California, Verenigde Staten, 90242
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Duarte, California, Verenigde Staten, 91010
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Encino, California, Verenigde Staten, 91436
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Fresno, California, Verenigde Staten, 93720
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Greenbrae, California, Verenigde Staten, 94904
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Huntington Beach, California, Verenigde Staten, 92648
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Inglewood, California, Verenigde Staten, 90301
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La Jolla, California, Verenigde Staten, 92037
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La Mesa, California, Verenigde Staten, 91942
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Lancaster, California, Verenigde Staten, 93534
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Long Beach, California, Verenigde Staten, 90822
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Los Alamitos, California, Verenigde Staten, 90720
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Mission Hills, California, Verenigde Staten, 91345
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Montclair, California, Verenigde Staten, 91763
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Monterey, California, Verenigde Staten, 93940
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North Hollywood, California, Verenigde Staten, 91606
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Palm Springs, California, Verenigde Staten, 92262
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Poway, California, Verenigde Staten, 92064
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San Diego, California, Verenigde Staten, 92111
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San Diego, California, Verenigde Staten, 92120
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San Ramon, California, Verenigde Staten, 94583
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Santa Ana, California, Verenigde Staten, 92704
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Sherman Oaks, California, Verenigde Staten, 91403
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Thousand Oaks, California, Verenigde Staten, 91360
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Tustin, California, Verenigde Staten, 92780
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Ventura, California, Verenigde Staten, 93003
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Vista, California, Verenigde Staten, 92083
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Westminster, California, Verenigde Staten, 92683
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80909
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Denver, Colorado, Verenigde Staten, 80220
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Denver, Colorado, Verenigde Staten, 80246
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Golden, Colorado, Verenigde Staten, 80401
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Connecticut
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Danbury, Connecticut, Verenigde Staten, 06810
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Norwalk, Connecticut, Verenigde Staten, 06851
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Waterbury, Connecticut, Verenigde Staten, 06708
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Florida
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Boca Raton, Florida, Verenigde Staten, 33433
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Boynton Beach, Florida, Verenigde Staten, 33472
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Bradenton, Florida, Verenigde Staten, 34201
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Brandon, Florida, Verenigde Staten, 33511
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Clearwater, Florida, Verenigde Staten, 33756
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Cooper City, Florida, Verenigde Staten, 33024
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Fleming Island, Florida, Verenigde Staten, 32003
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Fort Lauderdale, Florida, Verenigde Staten, 33316
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Gainesville, Florida, Verenigde Staten, 32610
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Green Cove Springs, Florida, Verenigde Staten, 32043
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Hialeah, Florida, Verenigde Staten, 33012
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Jacksonville, Florida, Verenigde Staten, 32216
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Jacksonville, Florida, Verenigde Staten, 32207
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Miami, Florida, Verenigde Staten, 33135
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Miami, Florida, Verenigde Staten, 33136
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Miami, Florida, Verenigde Staten, 33183
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Miami, Florida, Verenigde Staten, 33155
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Miami, Florida, Verenigde Staten, 33165
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Naples, Florida, Verenigde Staten, 34119
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New Port Richey, Florida, Verenigde Staten, 34652
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Orlando, Florida, Verenigde Staten, 32806
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Panama City, Florida, Verenigde Staten, 32401
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Ponte Vedra, Florida, Verenigde Staten, 32081
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Port Charlotte, Florida, Verenigde Staten, 33952
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Port Orange, Florida, Verenigde Staten, 32127
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South Miami, Florida, Verenigde Staten, 33143
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Tampa, Florida, Verenigde Staten, 33624
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Tampa, Florida, Verenigde Staten, 33619
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30339
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Decatur, Georgia, Verenigde Staten, 30033
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Dunwoody, Georgia, Verenigde Staten, 30338
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Lawrenceville, Georgia, Verenigde Staten, 30046
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Roswell, Georgia, Verenigde Staten, 30076
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Savannah, Georgia, Verenigde Staten, 31406
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96814
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Idaho
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Idaho Falls, Idaho, Verenigde Staten, 83404-7596
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Illinois
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Addison, Illinois, Verenigde Staten, 60101
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Champaign, Illinois, Verenigde Staten, 61821
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Chicago, Illinois, Verenigde Staten, 60607
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Chicago, Illinois, Verenigde Staten, 60616
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Crystal Lake, Illinois, Verenigde Staten, 60012
- Novo Nordisk Investigational Site
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Gurnee, Illinois, Verenigde Staten, 60031
- Novo Nordisk Investigational Site
-
Hines, Illinois, Verenigde Staten, 60141
- Novo Nordisk Investigational Site
-
Springfield, Illinois, Verenigde Staten, 62711
- Novo Nordisk Investigational Site
-
Springfield, Illinois, Verenigde Staten, 62702
- Novo Nordisk Investigational Site
-
-
Indiana
-
Brownsburg, Indiana, Verenigde Staten, 46112
- Novo Nordisk Investigational Site
-
Evansville, Indiana, Verenigde Staten, 47714
- Novo Nordisk Investigational Site
-
Franklin, Indiana, Verenigde Staten, 46131
- Novo Nordisk Investigational Site
-
Greenfield, Indiana, Verenigde Staten, 46140
- Novo Nordisk Investigational Site
-
Indianapolis, Indiana, Verenigde Staten, 46254
- Novo Nordisk Investigational Site
-
Michigan City, Indiana, Verenigde Staten, 46360
- Novo Nordisk Investigational Site
-
Muncie, Indiana, Verenigde Staten, 47304
- Novo Nordisk Investigational Site
-
-
Iowa
-
Council Bluffs, Iowa, Verenigde Staten, 51501
- Novo Nordisk Investigational Site
-
-
Kansas
-
Wichita, Kansas, Verenigde Staten, 67205
- Novo Nordisk Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, Verenigde Staten, 40503
- Novo Nordisk Investigational Site
-
Lexington, Kentucky, Verenigde Staten, 40502
- Novo Nordisk Investigational Site
-
Louisville, Kentucky, Verenigde Staten, 40213
- Novo Nordisk Investigational Site
-
Louisville, Kentucky, Verenigde Staten, 40206
- Novo Nordisk Investigational Site
-
Madisonville, Kentucky, Verenigde Staten, 42431
- Novo Nordisk Investigational Site
-
-
Louisiana
-
Monroe, Louisiana, Verenigde Staten, 71203
- Novo Nordisk Investigational Site
-
New Orleans, Louisiana, Verenigde Staten, 70119
- Novo Nordisk Investigational Site
-
Shreveport, Louisiana, Verenigde Staten, 71103
- Novo Nordisk Investigational Site
-
Slidell, Louisiana, Verenigde Staten, 70461-4231
- Novo Nordisk Investigational Site
-
-
Maine
-
Bangor, Maine, Verenigde Staten, 04401
- Novo Nordisk Investigational Site
-
-
Maryland
-
Hyattsville, Maryland, Verenigde Staten, 20782
- Novo Nordisk Investigational Site
-
Rockville, Maryland, Verenigde Staten, 20852
- Novo Nordisk Investigational Site
-
-
Massachusetts
-
Watertown, Massachusetts, Verenigde Staten, 02472
- Novo Nordisk Investigational Site
-
Worcester, Massachusetts, Verenigde Staten, 01655
- Novo Nordisk Investigational Site
-
-
Michigan
-
Ann Arbor, Michigan, Verenigde Staten, 48106
- Novo Nordisk Investigational Site
-
Ann Arbor, Michigan, Verenigde Staten, 48105
- Novo Nordisk Investigational Site
-
Buckley, Michigan, Verenigde Staten, 49620
- Novo Nordisk Investigational Site
-
Detroit, Michigan, Verenigde Staten, 48201
- Novo Nordisk Investigational Site
-
Detroit, Michigan, Verenigde Staten, 48202
- Novo Nordisk Investigational Site
-
Kalamazoo, Michigan, Verenigde Staten, 49009
- Novo Nordisk Investigational Site
-
Livonia, Michigan, Verenigde Staten, 48152
- Novo Nordisk Investigational Site
-
Troy, Michigan, Verenigde Staten, 48098
- Novo Nordisk Investigational Site
-
-
Mississippi
-
Olive Branch, Mississippi, Verenigde Staten, 38654
- Novo Nordisk Investigational Site
-
-
Missouri
-
Hazelwood, Missouri, Verenigde Staten, 63042
- Novo Nordisk Investigational Site
-
Jefferson City, Missouri, Verenigde Staten, 65109
- Novo Nordisk Investigational Site
-
Kansas City, Missouri, Verenigde Staten, 64111
- Novo Nordisk Investigational Site
-
-
Montana
-
Billings, Montana, Verenigde Staten, 59101
- Novo Nordisk Investigational Site
-
Kalispell, Montana, Verenigde Staten, 59901
- Novo Nordisk Investigational Site
-
-
Nebraska
-
Elkhorn, Nebraska, Verenigde Staten, 68022
- Novo Nordisk Investigational Site
-
Fremont, Nebraska, Verenigde Staten, 68025
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Verenigde Staten, 68114
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Verenigde Staten, 68105
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Verenigde Staten, 68124
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Verenigde Staten, 68144
- Novo Nordisk Investigational Site
-
Omaha, Nebraska, Verenigde Staten, 68198-4120
- Novo Nordisk Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89148
- Novo Nordisk Investigational Site
-
Las Vegas, Nevada, Verenigde Staten, 89128
- Novo Nordisk Investigational Site
-
Las Vegas, Nevada, Verenigde Staten, 89120
- Novo Nordisk Investigational Site
-
-
New Hampshire
-
Nashua, New Hampshire, Verenigde Staten, 03063
- Novo Nordisk Investigational Site
-
-
New Jersey
-
East Brunswick, New Jersey, Verenigde Staten, 08816
- Novo Nordisk Investigational Site
-
Hoboken, New Jersey, Verenigde Staten, 07030
- Novo Nordisk Investigational Site
-
-
New York
-
Albany, New York, Verenigde Staten, 12206
- Novo Nordisk Investigational Site
-
Lake Success, New York, Verenigde Staten, 11042
- Novo Nordisk Investigational Site
-
Mineola, New York, Verenigde Staten, 11501
- Novo Nordisk Investigational Site
-
New Windsor, New York, Verenigde Staten, 12553
- Novo Nordisk Investigational Site
-
New York, New York, Verenigde Staten, 10029
- Novo Nordisk Investigational Site
-
North Massapequa, New York, Verenigde Staten, 11758-1802
- Novo Nordisk Investigational Site
-
Northport, New York, Verenigde Staten, 11768
- Novo Nordisk Investigational Site
-
Rochester, New York, Verenigde Staten, 14607
- Novo Nordisk Investigational Site
-
West Seneca, New York, Verenigde Staten, 14224
- Novo Nordisk Investigational Site
-
Westfield, New York, Verenigde Staten, 14787
- Novo Nordisk Investigational Site
-
-
North Carolina
-
Asheville, North Carolina, Verenigde Staten, 28803
- Novo Nordisk Investigational Site
-
Asheville, North Carolina, Verenigde Staten, 28801
- Novo Nordisk Investigational Site
-
Burlington, North Carolina, Verenigde Staten, 27215
- Novo Nordisk Investigational Site
-
Cary, North Carolina, Verenigde Staten, 27518
- Novo Nordisk Investigational Site
-
Chapel Hill, North Carolina, Verenigde Staten, 27517
- Novo Nordisk Investigational Site
-
Charlotte, North Carolina, Verenigde Staten, 28209
- Novo Nordisk Investigational Site
-
Greenville, North Carolina, Verenigde Staten, 27834
- Novo Nordisk Investigational Site
-
Lexington, North Carolina, Verenigde Staten, 27292
- Novo Nordisk Investigational Site
-
Morehead City, North Carolina, Verenigde Staten, 28557
- Novo Nordisk Investigational Site
-
New Bern, North Carolina, Verenigde Staten, 28562
- Novo Nordisk Investigational Site
-
Statesville, North Carolina, Verenigde Staten, 28625
- Novo Nordisk Investigational Site
-
Whiteville, North Carolina, Verenigde Staten, 28472
- Novo Nordisk Investigational Site
-
Wilmington, North Carolina, Verenigde Staten, 28401
- Novo Nordisk Investigational Site
-
Winston-Salem, North Carolina, Verenigde Staten, 27103
- Novo Nordisk Investigational Site
-
-
North Dakota
-
Fargo, North Dakota, Verenigde Staten, 58104
- Novo Nordisk Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, Verenigde Staten, 45236
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, Verenigde Staten, 44195
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, Verenigde Staten, 44106-1702
- Novo Nordisk Investigational Site
-
Cleveland, Ohio, Verenigde Staten, 44121
- Novo Nordisk Investigational Site
-
Columbus, Ohio, Verenigde Staten, 43235
- Novo Nordisk Investigational Site
-
Delaware, Ohio, Verenigde Staten, 43015
- Novo Nordisk Investigational Site
-
Franklin, Ohio, Verenigde Staten, 45005
- Novo Nordisk Investigational Site
-
Maumee, Ohio, Verenigde Staten, 43537
- Novo Nordisk Investigational Site
-
Mentor, Ohio, Verenigde Staten, 44060
- Novo Nordisk Investigational Site
-
Perrysburg, Ohio, Verenigde Staten, 43551
- Novo Nordisk Investigational Site
-
-
Oklahoma
-
Norman, Oklahoma, Verenigde Staten, 73069
- Novo Nordisk Investigational Site
-
Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Novo Nordisk Investigational Site
-
-
Oregon
-
Portland, Oregon, Verenigde Staten, 97239-3098
- Novo Nordisk Investigational Site
-
-
Pennsylvania
-
Altoona, Pennsylvania, Verenigde Staten, 16602
- Novo Nordisk Investigational Site
-
Beaver, Pennsylvania, Verenigde Staten, 15009
- Novo Nordisk Investigational Site
-
Danville, Pennsylvania, Verenigde Staten, 17822
- Novo Nordisk Investigational Site
-
Hermitage, Pennsylvania, Verenigde Staten, 16148
- Novo Nordisk Investigational Site
-
Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Novo Nordisk Investigational Site
-
Philadelphia, Pennsylvania, Verenigde Staten, 19114
- Novo Nordisk Investigational Site
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15243
- Novo Nordisk Investigational Site
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15212
- Novo Nordisk Investigational Site
-
Smithfield, Pennsylvania, Verenigde Staten, 15478
- Novo Nordisk Investigational Site
-
Uniontown, Pennsylvania, Verenigde Staten, 15401
- Novo Nordisk Investigational Site
-
Upper Darby, Pennsylvania, Verenigde Staten, 19082
- Novo Nordisk Investigational Site
-
Wilkes-Barre, Pennsylvania, Verenigde Staten, 18702
- Novo Nordisk Investigational Site
-
-
South Carolina
-
Anderson, South Carolina, Verenigde Staten, 29621
- Novo Nordisk Investigational Site
-
Greer, South Carolina, Verenigde Staten, 29651
- Novo Nordisk Investigational Site
-
Moncks Corner, South Carolina, Verenigde Staten, 29461
- Novo Nordisk Investigational Site
-
Murrells Inlet, South Carolina, Verenigde Staten, 29576
- Novo Nordisk Investigational Site
-
Myrtle Beach, South Carolina, Verenigde Staten, 29572
- Novo Nordisk Investigational Site
-
Orangeburg, South Carolina, Verenigde Staten, 29118
- Novo Nordisk Investigational Site
-
Spartanburg, South Carolina, Verenigde Staten, 29303
- Novo Nordisk Investigational Site
-
-
Tennessee
-
Chattanooga, Tennessee, Verenigde Staten, 37404
- Novo Nordisk Investigational Site
-
Chattanooga, Tennessee, Verenigde Staten, 37411
- Novo Nordisk Investigational Site
-
Chattanooga, Tennessee, Verenigde Staten, 37404-1192
- Novo Nordisk Investigational Site
-
Kingsport, Tennessee, Verenigde Staten, 37660
- Novo Nordisk Investigational Site
-
Knoxville, Tennessee, Verenigde Staten, 37938
- Novo Nordisk Investigational Site
-
Memphis, Tennessee, Verenigde Staten, 38119
- Novo Nordisk Investigational Site
-
Memphis, Tennessee, Verenigde Staten, 38163
- Novo Nordisk Investigational Site
-
Nashville, Tennessee, Verenigde Staten, 37212
- Novo Nordisk Investigational Site
-
Nashville, Tennessee, Verenigde Staten, 37203
- Novo Nordisk Investigational Site
-
Nashville, Tennessee, Verenigde Staten, 37208
- Novo Nordisk Investigational Site
-
Tullahoma, Tennessee, Verenigde Staten, 37388
- Novo Nordisk Investigational Site
-
-
Texas
-
Arlington, Texas, Verenigde Staten, 76012
- Novo Nordisk Investigational Site
-
Austin, Texas, Verenigde Staten, 78731
- Novo Nordisk Investigational Site
-
Austin, Texas, Verenigde Staten, 78749
- Novo Nordisk Investigational Site
-
Austin, Texas, Verenigde Staten, 78705
- Novo Nordisk Investigational Site
-
Carrollton, Texas, Verenigde Staten, 75010
- Novo Nordisk Investigational Site
-
Carrollton, Texas, Verenigde Staten, 75007
- Novo Nordisk Investigational Site
-
Corpus Christi, Texas, Verenigde Staten, 78404
- Novo Nordisk Investigational Site
-
Dallas, Texas, Verenigde Staten, 75230
- Novo Nordisk Investigational Site
-
Dallas, Texas, Verenigde Staten, 75390-9302
- Novo Nordisk Investigational Site
-
Dallas, Texas, Verenigde Staten, 75231
- Novo Nordisk Investigational Site
-
Dallas, Texas, Verenigde Staten, 75246
- Novo Nordisk Investigational Site
-
Fort Worth, Texas, Verenigde Staten, 76117
- Novo Nordisk Investigational Site
-
Fort Worth, Texas, Verenigde Staten, 76132
- Novo Nordisk Investigational Site
-
Houston, Texas, Verenigde Staten, 77024
- Novo Nordisk Investigational Site
-
Houston, Texas, Verenigde Staten, 77061
- Novo Nordisk Investigational Site
-
Houston, Texas, Verenigde Staten, 77008
- Novo Nordisk Investigational Site
-
Houston, Texas, Verenigde Staten, 77070
- Novo Nordisk Investigational Site
-
Houston, Texas, Verenigde Staten, 77099
- Novo Nordisk Investigational Site
-
Houston, Texas, Verenigde Staten, 77060
- Novo Nordisk Investigational Site
-
Houston, Texas, Verenigde Staten, 77029
- Novo Nordisk Investigational Site
-
Houston, Texas, Verenigde Staten, 77093
- Novo Nordisk Investigational Site
-
Humble, Texas, Verenigde Staten, 77338
- Novo Nordisk Investigational Site
-
Hurst, Texas, Verenigde Staten, 76054
- Novo Nordisk Investigational Site
-
Irving, Texas, Verenigde Staten, 75039
- Novo Nordisk Investigational Site
-
Lewisville, Texas, Verenigde Staten, 75067
- Novo Nordisk Investigational Site
-
Longview, Texas, Verenigde Staten, 75605
- Novo Nordisk Investigational Site
-
Lubbock, Texas, Verenigde Staten, 79423
- Novo Nordisk Investigational Site
-
Midland, Texas, Verenigde Staten, 79707
- Novo Nordisk Investigational Site
-
Odessa, Texas, Verenigde Staten, 79761
- Novo Nordisk Investigational Site
-
Pearland, Texas, Verenigde Staten, 77584
- Novo Nordisk Investigational Site
-
Richardson, Texas, Verenigde Staten, 75080
- Novo Nordisk Investigational Site
-
Round Rock, Texas, Verenigde Staten, 78681
- Novo Nordisk Investigational Site
-
San Antonio, Texas, Verenigde Staten, 78229
- Novo Nordisk Investigational Site
-
San Antonio, Texas, Verenigde Staten, 78215
- Novo Nordisk Investigational Site
-
San Antonio, Texas, Verenigde Staten, 78228-6205
- Novo Nordisk Investigational Site
-
San Antonio, Texas, Verenigde Staten, 78258
- Novo Nordisk Investigational Site
-
Splendora, Texas, Verenigde Staten, 77372
- Novo Nordisk Investigational Site
-
Sugar Land, Texas, Verenigde Staten, 77478
- Novo Nordisk Investigational Site
-
Sugar Land, Texas, Verenigde Staten, 77479
- Novo Nordisk Investigational Site
-
Waco, Texas, Verenigde Staten, 76710
- Novo Nordisk Investigational Site
-
-
Utah
-
Salt Lake City, Utah, Verenigde Staten, 84102
- Novo Nordisk Investigational Site
-
Salt Lake City, Utah, Verenigde Staten, 84132
- Novo Nordisk Investigational Site
-
-
Vermont
-
Bennington, Vermont, Verenigde Staten, 05201
- Novo Nordisk Investigational Site
-
South Burlington, Vermont, Verenigde Staten, 05403
- Novo Nordisk Investigational Site
-
-
Virginia
-
Midlothian, Virginia, Verenigde Staten, 23114
- Novo Nordisk Investigational Site
-
Norfolk, Virginia, Verenigde Staten, 23510
- Novo Nordisk Investigational Site
-
Richmond, Virginia, Verenigde Staten, 23249
- Novo Nordisk Investigational Site
-
Winchester, Virginia, Verenigde Staten, 22601-3834
- Novo Nordisk Investigational Site
-
-
Washington
-
Richland, Washington, Verenigde Staten, 99352
- Novo Nordisk Investigational Site
-
Spokane, Washington, Verenigde Staten, 99201
- Novo Nordisk Investigational Site
-
-
Wisconsin
-
Kenosha, Wisconsin, Verenigde Staten, 53144
- Novo Nordisk Investigational Site
-
Milwaukee, Wisconsin, Verenigde Staten, 53209
- Novo Nordisk Investigational Site
-
Milwaukee, Wisconsin, Verenigde Staten, 53295
- Novo Nordisk Investigational Site
-
-
-
-
Eastern Cape
-
Port Elizabeth, Eastern Cape, Zuid-Afrika, 6045
- Novo Nordisk Investigational Site
-
Port Elizabeth, Eastern Cape, Zuid-Afrika, 6014
- Novo Nordisk Investigational Site
-
-
Gauteng
-
Johannesburg, Gauteng, Zuid-Afrika, 2193
- Novo Nordisk Investigational Site
-
Johannesburg, Gauteng, Zuid-Afrika, 1818
- Novo Nordisk Investigational Site
-
Johannesburg, Gauteng, Zuid-Afrika, 2198
- Novo Nordisk Investigational Site
-
Pretoria, Gauteng, Zuid-Afrika, 0001
- Novo Nordisk Investigational Site
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, Zuid-Afrika, 4001
- Novo Nordisk Investigational Site
-
Durban, KwaZulu-Natal, Zuid-Afrika, 4092
- Novo Nordisk Investigational Site
-
Umkomaas, KwaZulu-Natal, Zuid-Afrika, 4170
- Novo Nordisk Investigational Site
-
-
Mpumalanga
-
Middleburg, Mpumalanga, Zuid-Afrika, 1055
- Novo Nordisk Investigational Site
-
-
North West
-
Brits, North West, Zuid-Afrika, 0250
- Novo Nordisk Investigational Site
-
-
Western Cape
-
Cape Town, Western Cape, Zuid-Afrika, 7130
- Novo Nordisk Investigational Site
-
Cape Town, Western Cape, Zuid-Afrika, 7500
- Novo Nordisk Investigational Site
-
Cape Town, Western Cape, Zuid-Afrika, 7700
- Novo Nordisk Investigational Site
-
Cape Town, Western Cape, Zuid-Afrika, 7460
- Novo Nordisk Investigational Site
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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)
|
|
Actieve vergelijker: 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)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of EAC-confirmed Severe Hypoglycaemic Episodes
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Randomisation to 24 months
|
Mean change in HbA1c from week 0 to month 24.
|
Randomisation to 24 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
29 oktober 2013
Primaire voltooiing (Werkelijk)
16 oktober 2016
Studie voltooiing (Werkelijk)
16 oktober 2016
Studieregistratiedata
Eerst ingediend
8 oktober 2013
Eerst ingediend dat voldeed aan de QC-criteria
8 oktober 2013
Eerst geplaatst (Schatting)
10 oktober 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 juli 2019
Laatste update ingediend die voldeed aan QC-criteria
10 juli 2019
Laatst geverifieerd
1 juli 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EX1250-4080
- 2013-002371-17 (EudraCT-nummer)
- U1111-1141-7614 (Andere identificatie: WHO)
- JapicCTI-142464 (Register-ID: JAPIC)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .