A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE)

July 10, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7637

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Algeria
      • Algiers, Algeria, 16000
        • Novo Nordisk Investigational Site
      • Constantine, Algeria, 25000
        • Novo Nordisk Investigational Site
      • Oran, Algeria, 31000
        • Novo Nordisk Investigational Site
      • Sidi Bel Abbes, Algeria, 22000
        • Novo Nordisk Investigational Site
  • Argentina
      • Caba, Argentina, C1440AAD
        • Novo Nordisk Investigational Site
      • Cordoba, Argentina, 5000
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7600FZN
        • Novo Nordisk Investigational Site
      • Rosario, Argentina, S2000CUD
        • Novo Nordisk Investigational Site
      • Zarate, Argentina, B2800DGH
        • Novo Nordisk Investigational Site
  • Brazil
      • Fortaleza, Brazil, 60430-350
        • Novo Nordisk Investigational Site
      • Porto Alegre, Brazil, 90035-170
        • Novo Nordisk Investigational Site
    • Ceara
      • Fortaleza, Ceara, Brazil, 60115-282
        • Novo Nordisk Investigational Site
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 71625-009
        • Novo Nordisk Investigational Site
    • Goias
      • Aparecida de Goiania, Goias, Brazil, 74935-530
        • Novo Nordisk Investigational Site
    • Para
      • Belém, Para, Brazil, 66073-000
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • Mogi das Cruzes, Sao Paulo, Brazil, 08780-090
        • Novo Nordisk Investigational Site
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Novo Nordisk Investigational Site
      • São Paulo, Sao Paulo, Brazil, 01223-001
        • Novo Nordisk Investigational Site
      • São Paulo, Sao Paulo, Brazil, 01228-000
        • Novo Nordisk Investigational Site
      • São Paulo, Sao Paulo, Brazil, 01228-200
        • Novo Nordisk Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk Investigational Site
    • Ontario
      • Chatham, Ontario, Canada, N7L 1C1
        • Novo Nordisk Investigational Site
      • Ottawa, Ontario, Canada, K1K 4L2
        • Novo Nordisk Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Novo Nordisk Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Novo Nordisk Investigational Site
  • Croatia
      • Bjelovar, Croatia, 43000
        • Novo Nordisk Investigational Site
      • Osijek, Croatia, 31 000
        • Novo Nordisk Investigational Site
      • Slavonski Brod, Croatia, 35 000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10000
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-17562
        • Novo Nordisk Investigational Site
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
      • Athens, Greece, GR-115 27
        • Novo Nordisk Investigational Site
      • Athens, Greece, GR-10552
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-57001
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-54642
        • Novo Nordisk Investigational Site
  • India
      • Ludhiana, India, 141001
        • Novo Nordisk Investigational Site
      • New Delhi, India, 110001
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Novo Nordisk Investigational Site
      • Hyderbad, Andhra Pradesh, India, 500 012
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Novo Nordisk Investigational Site
      • Ahmedabad, Gujarat, India, 380052
        • Novo Nordisk Investigational Site
      • Ahmedabad, Gujarat, India, 380007
        • Novo Nordisk Investigational Site
      • Ahmedabad, Gujarat, India, 380016
        • Novo Nordisk Investigational Site
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Novo Nordisk Investigational Site
      • Bangalore, Karnataka, India, 560 017
        • Novo Nordisk Investigational Site
    • Kerala
      • Kozhikode, Kerala, India, 673017
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Goa, Maharashtra, India, 403 202
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400012
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400022
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400010
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400007
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411001
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411040
        • Novo Nordisk Investigational Site
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • Novo Nordisk Investigational Site
    • Orissa
      • Bhubaneswar, Orissa, India, 751005
        • Novo Nordisk Investigational Site
    • Punjab
      • Mohali, Punjab, India, 160062
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India, 600031
        • Novo Nordisk Investigational Site
      • Coimbatore, Tamil Nadu, India, 641018
        • Novo Nordisk Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Novo Nordisk Investigational Site
      • Kolkata, West Bengal, India, 700054
        • Novo Nordisk Investigational Site
  • Italy
      • Bari, Italy, 70124
        • Novo Nordisk Investigational Site
      • Bergamo, Italy, 24127
        • Novo Nordisk Investigational Site
      • Catanzaro, Italy, 88100
        • Novo Nordisk Investigational Site
      • Chieti, Italy, 66100
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20122
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20162
        • Novo Nordisk Investigational Site
      • Milano (MI), Italy, 20132
        • Novo Nordisk Investigational Site
      • Olbia, Italy, 07026
        • Novo Nordisk Investigational Site
      • Padova, Italy, 35143
        • Novo Nordisk Investigational Site
      • Palermo, Italy, 90127
        • Novo Nordisk Investigational Site
      • Ravenna, Italy, 48121
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00161
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00133
        • Novo Nordisk Investigational Site
      • Sesto San Giovanni (MI), Italy, 20099
        • Novo Nordisk Investigational Site
  • Japan
      • Chuo-ku, Tokyo, Japan, 103-0002
        • Novo Nordisk Investigational Site
      • Kanagawa, Japan, 235-0045
        • Novo Nordisk Investigational Site
      • Kumamoto, Japan, 862-0976
        • Novo Nordisk Investigational Site
      • Miyazaki, Japan, 880-0034
        • Novo Nordisk Investigational Site
      • Nagano, Japan, 390-8621
        • Novo Nordisk Investigational Site
      • Ota-ku, Japan, 144 0035
        • Novo Nordisk Investigational Site
      • Ota-ku, Tokyo, Japan, 1430015
        • Novo Nordisk Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Goyang, Korea, Republic of, 10380
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 02841
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 03080
        • Novo Nordisk Investigational Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
        • Novo Nordisk Investigational Site
  • Malaysia
      • Alor Setar, Malaysia, 05460
        • Novo Nordisk Investigational Site
      • Kota Samarahan, Malaysia, 94300
        • Novo Nordisk Investigational Site
      • Kuala Lumpur, Malaysia, 59100
        • Novo Nordisk Investigational Site
      • Kuantan, Malaysia, 25100
        • Novo Nordisk Investigational Site
      • Melaka, Malaysia, 75400
        • Novo Nordisk Investigational Site
      • Serdang, Malaysia, 43000
        • Novo Nordisk Investigational Site
      • Seremban, Malaysia, 70300
        • Novo Nordisk Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk Investigational Site
      • Chihuahua, Mexico, 31200
        • Novo Nordisk Investigational Site
      • San Luis Potosi, Mexico, 78200
        • Novo Nordisk Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Novo Nordisk Investigational Site
      • Guadalajara, Jalisco, Mexico, 44130
        • Novo Nordisk Investigational Site
      • Guadalajara, Jalisco, Mexico, 44650
        • Novo Nordisk Investigational Site
      • Guadalajara, Jalisco, Mexico, 44670
        • Novo Nordisk Investigational Site
      • Guadalajara, Jalisco, Mexico, 44150
        • Novo Nordisk Investigational Site
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Distrito Federal, México, D.F., Mexico, 14080
        • Novo Nordisk Investigational Site
  • Poland
      • Bytom, Poland, 41-902
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-546
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-455
        • Novo Nordisk Investigational Site
      • Oswiecim, Poland, 32-600
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-589
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 70-506
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
      • Zamosc, Poland, 22-400
        • Novo Nordisk Investigational Site
  • Romania
    • Alba
      • Alba Iulia, Alba, Romania, 510053
        • Novo Nordisk Investigational Site
    • Maramures
      • Baia Mare, Maramures, Romania, 430222
        • Novo Nordisk Investigational Site
    • Mures
      • Targu Mures, Mures, Romania, 540142
        • Novo Nordisk Investigational Site
    • Prahova
      • Ploiesti, Prahova, Romania, 100163
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • Novo Nordisk Investigational Site
      • Kemerovo, Russian Federation, 650002
        • Novo Nordisk Investigational Site
      • Kirov, Russian Federation, 610014
        • Novo Nordisk Investigational Site
      • Krasnodar, Russian Federation, 350012
        • Novo Nordisk Investigational Site
      • Krasnodar, Russian Federation, 350086
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 123423
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 111539
        • Novo Nordisk Investigational Site
      • Nizhny Novgorod, Russian Federation, 603018
        • Novo Nordisk Investigational Site
      • Rostov-on-Don, Russian Federation, 344068
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194356
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 195213
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191119
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410053
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410031
        • Novo Nordisk Investigational Site
      • St. Petersburg, Russian Federation, 194354
        • Novo Nordisk Investigational Site
      • St. Petersburg, Russian Federation, 196084
        • Novo Nordisk Investigational Site
      • Syktyvkar, Russian Federation, 167981
        • Novo Nordisk Investigational Site
      • Tumen, Russian Federation, 625023
        • Novo Nordisk Investigational Site
      • Tver, Russian Federation, 170036
        • Novo Nordisk Investigational Site
      • Ulianovsk, Russian Federation, 432063
        • Novo Nordisk Investigational Site
      • Volgograd, Russian Federation, 400131
        • Novo Nordisk Investigational Site
      • Yaroslavl, Russian Federation, 150010
        • Novo Nordisk Investigational Site
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Novo Nordisk Investigational Site
      • Port Elizabeth, Eastern Cape, South Africa, 6014
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1818
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 2198
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0001
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Novo Nordisk Investigational Site
      • Umkomaas, KwaZulu-Natal, South Africa, 4170
        • Novo Nordisk Investigational Site
    • Mpumalanga
      • Middleburg, Mpumalanga, South Africa, 1055
        • Novo Nordisk Investigational Site
    • North West
      • Brits, North West, South Africa, 0250
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa, 7500
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa, 7700
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa, 7460
        • Novo Nordisk Investigational Site
  • Spain
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18003
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29006
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46014
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46015
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novo Nordisk Investigational Site
      • Bangkok, Thailand, 10330
        • Novo Nordisk Investigational Site
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Novo Nordisk Investigational Site
      • Chiang Mai, Thailand, 50200
        • Novo Nordisk Investigational Site
      • Nakhon Ratchasima, Thailand, 30000
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Novo Nordisk Investigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk Investigational Site
      • Norwich, United Kingdom, NR4 7TJ
        • Novo Nordisk Investigational Site
      • Nuneaton, United Kingdom, CV10 7DJ
        • Novo Nordisk Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk Investigational Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Novo Nordisk Investigational Site
      • Birmingham, Alabama, United States, 35216
        • Novo Nordisk Investigational Site
      • Montgomery, Alabama, United States, 36106
        • Novo Nordisk Investigational Site
      • Montgomery, Alabama, United States, 36109
        • Novo Nordisk Investigational Site
    • Arizona
      • Gilbert, Arizona, United States, 85295
        • Novo Nordisk Investigational Site
      • Glendale, Arizona, United States, 85308
        • Novo Nordisk Investigational Site
      • Litchfield Park, Arizona, United States, 85340
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85050
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85714
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85704
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85723
        • Novo Nordisk Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novo Nordisk Investigational Site
      • Little Rock, Arkansas, United States, 72205-5446
        • Novo Nordisk Investigational Site
      • Searcy, Arkansas, United States, 72143
        • Novo Nordisk Investigational Site
    • California
      • Chula Vista, California, United States, 91910
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Downey, California, United States, 90242
        • Novo Nordisk Investigational Site
      • Duarte, California, United States, 91010
        • Novo Nordisk Investigational Site
      • Encino, California, United States, 91436
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Greenbrae, California, United States, 94904
        • Novo Nordisk Investigational Site
      • Huntington Beach, California, United States, 92648
        • Novo Nordisk Investigational Site
      • Inglewood, California, United States, 90301
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • La Mesa, California, United States, 91942
        • Novo Nordisk Investigational Site
      • Lancaster, California, United States, 93534
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90822
        • Novo Nordisk Investigational Site
      • Los Alamitos, California, United States, 90720
        • Novo Nordisk Investigational Site
      • Mission Hills, California, United States, 91345
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • Monterey, California, United States, 93940
        • Novo Nordisk Investigational Site
      • North Hollywood, California, United States, 91606
        • Novo Nordisk Investigational Site
      • Palm Springs, California, United States, 92262
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92111
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92120
        • Novo Nordisk Investigational Site
      • San Ramon, California, United States, 94583
        • Novo Nordisk Investigational Site
      • Santa Ana, California, United States, 92704
        • Novo Nordisk Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Novo Nordisk Investigational Site
      • Thousand Oaks, California, United States, 91360
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
      • Ventura, California, United States, 93003
        • Novo Nordisk Investigational Site
      • Vista, California, United States, 92083
        • Novo Nordisk Investigational Site
      • Westminster, California, United States, 92683
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Novo Nordisk Investigational Site
      • Denver, Colorado, United States, 80220
        • Novo Nordisk Investigational Site
      • Denver, Colorado, United States, 80246
        • Novo Nordisk Investigational Site
      • Golden, Colorado, United States, 80401
        • Novo Nordisk Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Novo Nordisk Investigational Site
      • Norwalk, Connecticut, United States, 06851
        • Novo Nordisk Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Novo Nordisk Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33433
        • Novo Nordisk Investigational Site
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Brandon, Florida, United States, 33511
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33756
        • Novo Nordisk Investigational Site
      • Cooper City, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • Fleming Island, Florida, United States, 32003
        • Novo Nordisk Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • Novo Nordisk Investigational Site
      • Gainesville, Florida, United States, 32610
        • Novo Nordisk Investigational Site
      • Green Cove Springs, Florida, United States, 32043
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, United States, 33012
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33135
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33183
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33155
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33165
        • Novo Nordisk Investigational Site
      • Naples, Florida, United States, 34119
        • Novo Nordisk Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32806
        • Novo Nordisk Investigational Site
      • Panama City, Florida, United States, 32401
        • Novo Nordisk Investigational Site
      • Ponte Vedra, Florida, United States, 32081
        • Novo Nordisk Investigational Site
      • Port Charlotte, Florida, United States, 33952
        • Novo Nordisk Investigational Site
      • Port Orange, Florida, United States, 32127
        • Novo Nordisk Investigational Site
      • South Miami, Florida, United States, 33143
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33624
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33619
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Novo Nordisk Investigational Site
      • Decatur, Georgia, United States, 30033
        • Novo Nordisk Investigational Site
      • Dunwoody, Georgia, United States, 30338
        • Novo Nordisk Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Addison, Illinois, United States, 60101
        • Novo Nordisk Investigational Site
      • Champaign, Illinois, United States, 61821
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60616
        • Novo Nordisk Investigational Site
      • Crystal Lake, Illinois, United States, 60012
        • Novo Nordisk Investigational Site
      • Gurnee, Illinois, United States, 60031
        • Novo Nordisk Investigational Site
      • Hines, Illinois, United States, 60141
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62702
        • Novo Nordisk Investigational Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Novo Nordisk Investigational Site
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
      • Franklin, Indiana, United States, 46131
        • Novo Nordisk Investigational Site
      • Greenfield, Indiana, United States, 46140
        • Novo Nordisk Investigational Site
      • Indianapolis, Indiana, United States, 46254
        • Novo Nordisk Investigational Site
      • Michigan City, Indiana, United States, 46360
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Novo Nordisk Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Lexington, Kentucky, United States, 40502
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40206
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Novo Nordisk Investigational Site
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • Novo Nordisk Investigational Site
      • New Orleans, Louisiana, United States, 70119
        • Novo Nordisk Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • Novo Nordisk Investigational Site
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Novo Nordisk Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Novo Nordisk Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Novo Nordisk Investigational Site
      • Ann Arbor, Michigan, United States, 48105
        • Novo Nordisk Investigational Site
      • Buckley, Michigan, United States, 49620
        • Novo Nordisk Investigational Site
      • Detroit, Michigan, United States, 48201
        • Novo Nordisk Investigational Site
      • Detroit, Michigan, United States, 48202
        • Novo Nordisk Investigational Site
      • Kalamazoo, Michigan, United States, 49009
        • Novo Nordisk Investigational Site
      • Livonia, Michigan, United States, 48152
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48098
        • Novo Nordisk Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Novo Nordisk Investigational Site
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Novo Nordisk Investigational Site
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
      • Kansas City, Missouri, United States, 64111
        • Novo Nordisk Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Novo Nordisk Investigational Site
      • Kalispell, Montana, United States, 59901
        • Novo Nordisk Investigational Site
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Novo Nordisk Investigational Site
      • Fremont, Nebraska, United States, 68025
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68105
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68124
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68144
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68198-4120
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89120
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Novo Nordisk Investigational Site
      • Hoboken, New Jersey, United States, 07030
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
      • Lake Success, New York, United States, 11042
        • Novo Nordisk Investigational Site
      • Mineola, New York, United States, 11501
        • Novo Nordisk Investigational Site
      • New Windsor, New York, United States, 12553
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10029
        • Novo Nordisk Investigational Site
      • North Massapequa, New York, United States, 11758-1802
        • Novo Nordisk Investigational Site
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
      • Rochester, New York, United States, 14607
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
      • Westfield, New York, United States, 14787
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
      • Asheville, North Carolina, United States, 28801
        • Novo Nordisk Investigational Site
      • Burlington, North Carolina, United States, 27215
        • Novo Nordisk Investigational Site
      • Cary, North Carolina, United States, 27518
        • Novo Nordisk Investigational Site
      • Chapel Hill, North Carolina, United States, 27517
        • Novo Nordisk Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
      • Lexington, North Carolina, United States, 27292
        • Novo Nordisk Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Novo Nordisk Investigational Site
      • New Bern, North Carolina, United States, 28562
        • Novo Nordisk Investigational Site
      • Statesville, North Carolina, United States, 28625
        • Novo Nordisk Investigational Site
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Novo Nordisk Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44106-1702
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44121
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43235
        • Novo Nordisk Investigational Site
      • Delaware, Ohio, United States, 43015
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Maumee, Ohio, United States, 43537
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
      • Perrysburg, Ohio, United States, 43551
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Novo Nordisk Investigational Site
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Beaver, Pennsylvania, United States, 15009
        • Novo Nordisk Investigational Site
      • Danville, Pennsylvania, United States, 17822
        • Novo Nordisk Investigational Site
      • Hermitage, Pennsylvania, United States, 16148
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Novo Nordisk Investigational Site
      • Smithfield, Pennsylvania, United States, 15478
        • Novo Nordisk Investigational Site
      • Uniontown, Pennsylvania, United States, 15401
        • Novo Nordisk Investigational Site
      • Upper Darby, Pennsylvania, United States, 19082
        • Novo Nordisk Investigational Site
      • Wilkes-Barre, Pennsylvania, United States, 18702
        • Novo Nordisk Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Novo Nordisk Investigational Site
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Moncks Corner, South Carolina, United States, 29461
        • Novo Nordisk Investigational Site
      • Murrells Inlet, South Carolina, United States, 29576
        • Novo Nordisk Investigational Site
      • Myrtle Beach, South Carolina, United States, 29572
        • Novo Nordisk Investigational Site
      • Orangeburg, South Carolina, United States, 29118
        • Novo Nordisk Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37404-1192
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
      • Knoxville, Tennessee, United States, 37938
        • Novo Nordisk Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk Investigational Site
      • Memphis, Tennessee, United States, 38163
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37208
        • Novo Nordisk Investigational Site
      • Tullahoma, Tennessee, United States, 37388
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Novo Nordisk Investigational Site
      • Austin, Texas, United States, 78731
        • Novo Nordisk Investigational Site
      • Austin, Texas, United States, 78749
        • Novo Nordisk Investigational Site
      • Austin, Texas, United States, 78705
        • Novo Nordisk Investigational Site
      • Carrollton, Texas, United States, 75010
        • Novo Nordisk Investigational Site
      • Carrollton, Texas, United States, 75007
        • Novo Nordisk Investigational Site
      • Corpus Christi, Texas, United States, 78404
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-9302
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, United States, 76117
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, United States, 76132
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77024
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77061
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77008
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77070
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77099
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77060
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77029
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77093
        • Novo Nordisk Investigational Site
      • Humble, Texas, United States, 77338
        • Novo Nordisk Investigational Site
      • Hurst, Texas, United States, 76054
        • Novo Nordisk Investigational Site
      • Irving, Texas, United States, 75039
        • Novo Nordisk Investigational Site
      • Lewisville, Texas, United States, 75067
        • Novo Nordisk Investigational Site
      • Longview, Texas, United States, 75605
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79423
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • Odessa, Texas, United States, 79761
        • Novo Nordisk Investigational Site
      • Pearland, Texas, United States, 77584
        • Novo Nordisk Investigational Site
      • Richardson, Texas, United States, 75080
        • Novo Nordisk Investigational Site
      • Round Rock, Texas, United States, 78681
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78215
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78228-6205
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78258
        • Novo Nordisk Investigational Site
      • Splendora, Texas, United States, 77372
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site
      • Waco, Texas, United States, 76710
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, United States, 84132
        • Novo Nordisk Investigational Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Novo Nordisk Investigational Site
      • South Burlington, Vermont, United States, 05403
        • Novo Nordisk Investigational Site
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Novo Nordisk Investigational Site
      • Norfolk, Virginia, United States, 23510
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23249
        • Novo Nordisk Investigational Site
      • Winchester, Virginia, United States, 22601-3834
        • Novo Nordisk Investigational Site
    • Washington
      • Richland, Washington, United States, 99352
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99201
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Novo Nordisk Investigational Site
      • Milwaukee, Wisconsin, United States, 53209
        • Novo Nordisk Investigational Site
      • Milwaukee, Wisconsin, United States, 53295
        • Novo Nordisk Investigational Site

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Type 2 diabetes - Age 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)

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: insulin degludec
Injected once daily subcutaneously (s.c., under the skin)
Active Comparator: 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.
Drug: insulin glargine
Injected once daily subcutaneously (s.c., under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of EAC-confirmed Severe Hypoglycaemic Episodes
Time Frame: 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)
Time Frame: 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)
Time Frame: Randomisation to 24 months
Mean change in HbA1c from week 0 to month 24.
Randomisation to 24 months

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Publications and helpful links

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

General Publications

Helpful Links

Study record dates

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

Study Major Dates

Study Start (Actual)

October 29, 2013

Primary Completion (Actual)

October 16, 2016

Study Completion (Actual)

October 16, 2016

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX1250-4080
  • 2013-002371-17 (EudraCT Number)
  • U1111-1141-7614 (Other Identifier: WHO)
  • JapicCTI-142464 (Registry Identifier: JAPIC)

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

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