Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes (DUAL™ I)

A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: insulin degludec; Drug: insulin degludec/liraglutide; Drug: liraglutide

• Study Type: Interventional
• Enrollment (Actual): 1663
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Broadmeadow, New South Wales, Australia, 2292
      • Novo Nordisk Investigational Site
    • Camperdown, New South Wales, Australia, 2050
      • Novo Nordisk Investigational Site
    • Coffs Harbour, New South Wales, Australia, 2450
      • Novo Nordisk Investigational Site
    • Penrith, New South Wales, Australia, 2751
      • Novo Nordisk Investigational Site
  • Queensland
    • Meadowbrook, Queensland, Australia, 4131
      • Novo Nordisk Investigational Site
  • South Australia
    • Keswick, South Australia, Australia, 5035
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  • Victoria
    • East Ringwood, Victoria, Australia, 3135
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    • Melbourne, Victoria, Australia, 3004
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• Canada
  • Quebec, Canada, G1G 3Y8
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  • Quebec, Canada, G1N 4V3
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  • Alberta
    • Edmonton, Alberta, Canada, T5J 3N4
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  • British Columbia
    • Chilliwack, British Columbia, Canada, V2P 4M9
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    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Novo Nordisk Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
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  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
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    • Burlington, Ontario, Canada, L7R 1E2
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    • Cornwall, Ontario, Canada, K6H 4M4
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    • Hamilton, Ontario, Canada, L8L 5G8
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    • Hamilton, Ontario, Canada, L8M 1K7
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    • Mississauga, Ontario, Canada, L5M 2V8
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    • Toronto, Ontario, Canada, M3J 1N2
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  • Quebec
    • Drummondville, Quebec, Canada, J2B 7T1
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    • Laval, Quebec, Canada, H7T 2P5
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• Finland
  • Hanko, Finland, 10900
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  • Helsinki, Finland, 00180
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  • Imatra, Finland, FI-55120
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  • Kokkola, Finland, FI-67100
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  • Oulu, Finland, 90100
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• Germany
  • Bad Neuenahr-Ahrweiler, Germany, 53474
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  • Eisenach, Germany, 99817
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  • Esslingen, Germany, 73728
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  • Frankfurt, Germany, 60388
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  • Grevenbroich, Germany, 41515
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  • Hamburg, Germany, 21073
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  • Herrenberg, Germany, 71083
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  • Hohenmölsen, Germany, 06679
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  • Münster, Germany, 48145
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  • Oldenburg, Germany, 23758
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  • Pohlheim, Germany, 35415
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  • Rehburg-Loccum, Germany, 31547
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  • Rehlingen-Siersburg, Germany, 66780
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  • Stuttgart, Germany, 70378
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• Hungary
  • Budapest, Hungary, 1041
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  • Budapest, Hungary, H-1212
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  • Debrecen, Hungary, 4043
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  • Eger, Hungary, 3300
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  • Gyula, Hungary, 5700
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  • Pécs, Hungary, 7623
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  • Szeged, Hungary, H-6720
    • Novo Nordisk Investigational Site
• India
  • Hyderabad, India, 600034
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  • Kolkata, India, 700017
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  • Patna, India, 800020
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  • Pune, India, 411011
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  • Gujarat
    • Ahmedabad, Gujarat, India, 380006
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  • Haryana
    • Gurgaon, Haryana, India, 122001
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  • Karnataka
    • Bangalore, Karnataka, India, 560034
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    • Bangalore, Karnataka, India, 560092
      • Novo Nordisk Investigational Site
  • Kerala
    • Cochin, Kerala, India, 695010
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    • Kochi, Kerala, India, 682041
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    • Thiruvanathapuram, Kerala, India, 695010
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    • Trivandrum, Kerala, India, 695011
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  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452010
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  • Maharashtra
    • Mumbai, Maharashtra, India, 400008
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    • Mumbai, Maharashtra, India, 400012
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    • Pune, Maharashtra, India, 411 037
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  • Orissa
    • Bhubaneswar, Orissa, India, 751019
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  • Rajasthan
    • Jaipur, Rajasthan, India, 302006
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    • Jaipur, Rajasthan, India, 302017
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  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 013
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    • Chennai, Tamil Nadu, India, 600028
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    • Trichy, Tamil Nadu, India, 620018
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  • West Bengal
    • Kolkatta, West Bengal, India, 700031
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• Ireland
  • Dublin, Ireland, DUBLIN 7
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  • Galway, Ireland, H91 YR71
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• Italy
  • Cosenza, Italy, 87100
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  • Forlì, Italy, 47100
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  • Monserrato, Cagliari, Italy, 09042
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  • Novara, Italy, 28100
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  • Olbia, Italy, 07026
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  • Palermo, Italy, 90127
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  • Siena, Italy, 53100
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  • Torino, Italy, 10126
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• Malaysia
  • Cheras, Malaysia, 56000
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  • Kota Bharu, Kelantan, Malaysia, 16150
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  • Penang, Malaysia, 10459
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  • Pulau Pinang, Malaysia, 10990
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  • Putrajaya, Malaysia, 62250
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  • Seremban, Malaysia, 70300
    • Novo Nordisk Investigational Site
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
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  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Novo Nordisk Investigational Site
• Puerto Rico
  • San Juan, Puerto Rico, 00921
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• Russian Federation
  • Kursk, Russian Federation, 305035
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  • Moscow, Russian Federation, 119435
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 127411
    • Novo Nordisk Investigational Site
  • Penza, Russian Federation, 440026
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 194156
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 195257
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 199034
    • Novo Nordisk Investigational Site
  • Saratov, Russian Federation, 410053
    • Novo Nordisk Investigational Site
  • Stavropol, Russian Federation, 355017
    • Novo Nordisk Investigational Site
  • Voronezh, Russian Federation, 394018
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  • Vsevolozhsk, Russian Federation, 188643
    • Novo Nordisk Investigational Site
• Singapore
  • Singapore, Singapore, 119228
    • Novo Nordisk Investigational Site
  • Singapore, Singapore, 308433
    • Novo Nordisk Investigational Site
  • Singapore, Singapore, 768828
    • Novo Nordisk Investigational Site
• Slovakia
  • Bratislava, Slovakia, 821 03
    • Novo Nordisk Investigational Site
  • Lucenec, Slovakia, 984 01
    • Novo Nordisk Investigational Site
  • Moldava nad Bodvou, Slovakia, 045 01
    • Novo Nordisk Investigational Site
  • Nove Zamky, Slovakia, 940 59
    • Novo Nordisk Investigational Site
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6014
      • Novo Nordisk Investigational Site
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Novo Nordisk Investigational Site
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2001
      • Novo Nordisk Investigational Site
    • Johannesburg, Gauteng, South Africa, 1827
      • Novo Nordisk Investigational Site
    • Johannesburg, Gauteng, South Africa, 1812
      • Novo Nordisk Investigational Site
    • Johannesburg, Gauteng, South Africa, 2198
      • Novo Nordisk Investigational Site
    • Vaderbijlpark, Gauteng, South Africa, 1900
      • Novo Nordisk Investigational Site
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4126
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    • Durban, KwaZulu-Natal, South Africa, 4001
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    • Durban, KwaZulu-Natal, South Africa, 4091
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    • Durban, KwaZulu-Natal, South Africa, 4450
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    • Umkomaas, KwaZulu-Natal, South Africa, 4170
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  • North West
    • Brits, North West, South Africa, 0250
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  • Western Cape
    • Cape Town, Western Cape, South Africa, 7572
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• Spain
  • Almería, Spain, 04001
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  • Granada, Spain, 18012
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  • La Coruña, Spain, 15006
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  • Partida De Bacarot, Spain, 03114
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  • Sevilla, Spain, 41010
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  • Sevilla, Spain, 41003
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  • Valencia, Spain, 46026
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  • Valladolid, Spain, 47005
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• Taiwan
  • Taichung City, Taiwan, 407
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  • Tainan city, Taiwan, 710
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  • Taipei, Taiwan, 100
    • Novo Nordisk Investigational Site
  • Taoyuan, Taiwan, 333
    • Novo Nordisk Investigational Site
• Thailand
  • Bangkok, Thailand, 10400
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  • Bangkok, Thailand, 10330
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  • Bangkoknoi, Bangkok, Thailand, 10700
    • Novo Nordisk Investigational Site
  • Chiang Mai, Thailand, 50200
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• United Kingdom
  • Belfast, United Kingdom, BT16 1RH
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  • Bury St Edmunds, United Kingdom, IP33 2QZ
    • Novo Nordisk Investigational Site
  • Carmarthen, United Kingdom, SA31 2AF
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  • Dundee, United Kingdom, DD1 9SY
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  • Edgbaston, Birmingham, United Kingdom, B15 2TH
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  • Fife, United Kingdom, KY2 5AH
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  • Glasgow, United Kingdom, G45 9AW
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  • Gloucester, United Kingdom, GL1 3NN
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  • Headington, United Kingdom, OX3 7LE
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  • Lancaster, United Kingdom, LA1 4RP
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  • Letchworth, United Kingdom, SG6 4UB
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  • Llantrisant, United Kingdom, CF72 8XR
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  • London, United Kingdom, W6 7HY
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  • St Helens, United Kingdom, WA9 3DA
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  • Stevenage, United Kingdom, SG1 4AB
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  • Weston Super Mare, United Kingdom, BS23 4TQ
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  • Wrexham, United Kingdom, LL13 7TD
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Novo Nordisk Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • Bermuda Dunes, California, United States, 92203
      • Novo Nordisk Investigational Site
    • Concord, California, United States, 94520
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    • Encino, California, United States, 91436
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    • Fair Oaks, California, United States, 95628
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    • Fresno, California, United States, 93702
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    • Greenbrae, California, United States, 94904
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    • La Jolla, California, United States, 92037
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    • Long Beach, California, United States, 90807
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    • Los Angeles, California, United States, 90057
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    • Montclair, California, United States, 91763
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    • Monterey, California, United States, 93940
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    • Orange, California, United States, 92868
      • Novo Nordisk Investigational Site
    • Poway, California, United States, 92064
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92111
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    • San Diego, California, United States, 92117
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92161-0002
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    • San Mateo, California, United States, 94401
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    • Santa Barbara, California, United States, 93105
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    • Tustin, California, United States, 92780
      • Novo Nordisk Investigational Site
    • Valencia, California, United States, 91355
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    • Walnut Creek, California, United States, 94598
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  • Colorado
    • Colorado Springs, Colorado, United States, 80910
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    • Denver, Colorado, United States, 80209
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    • Golden, Colorado, United States, 80401
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  • Connecticut
    • Waterbury, Connecticut, United States, 06708
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  • Delaware
    • Newark, Delaware, United States, 19713
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  • Florida
    • Clearwater, Florida, United States, 33765
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    • Delray Beach, Florida, United States, 33484
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    • Fort Lauderdale, Florida, United States, 33316
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    • Hialeah, Florida, United States, 33012
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    • Jacksonville, Florida, United States, 32258
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    • Kissimmee, Florida, United States, 34741
      • Novo Nordisk Investigational Site
    • Melbourne, Florida, United States, 32934
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    • Miami, Florida, United States, 33156
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    • Miami, Florida, United States, 33135
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    • Orlando, Florida, United States, 32804
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    • Pembroke Pines, Florida, United States, 33027
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    • Tampa, Florida, United States, 33603
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  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Novo Nordisk Investigational Site
    • Columbus, Georgia, United States, 31909
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    • Conyers, Georgia, United States, 30094-5965
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    • Decatur, Georgia, United States, 30035
      • Novo Nordisk Investigational Site
    • Lawrenceville, Georgia, United States, 30046
      • Novo Nordisk Investigational Site
    • Roswell, Georgia, United States, 30076
      • Novo Nordisk Investigational Site
    • Woodstock, Georgia, United States, 30189-4255
      • Novo Nordisk Investigational Site
  • Idaho
    • Meridian, Idaho, United States, 83646
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    • Nampa, Idaho, United States, 83686-6011
      • Novo Nordisk Investigational Site
  • Illinois
    • Avon, Illinois, United States, 46123
      • Novo Nordisk Investigational Site
    • Chicago, Illinois, United States, 60607
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    • Gurnee, Illinois, United States, 60031
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    • O'Fallon, Illinois, United States, 62246
      • Novo Nordisk Investigational Site
  • Indiana
    • Fishers, Indiana, United States, 46038-1862
      • Novo Nordisk Investigational Site
    • Franklin, Indiana, United States, 46131
      • 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
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017-3464
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    • Lexington, Kentucky, United States, 40503
      • Novo Nordisk Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006-2930
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    • Metairie, Louisiana, United States, 70006
      • Novo Nordisk Investigational Site
  • Maryland
    • Hyattsville, Maryland, United States, 20782
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    • North East, Maryland, United States, 21901
      • Novo Nordisk Investigational Site
    • Rockville, Maryland, United States, 20852
      • Novo Nordisk Investigational Site
  • Michigan
    • Buckley, Michigan, United States, 49620
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    • Southfield, Michigan, United States, 48075
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    • Southfield, Michigan, United States, 48034-7661
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    • Troy, Michigan, United States, 48098
      • Novo Nordisk Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Novo Nordisk Investigational Site
    • Kansas City, Missouri, United States, 64111
      • Novo Nordisk Investigational Site
    • Saint Charles, Missouri, United States, 63303
      • Novo Nordisk Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89052-2649
      • Novo Nordisk Investigational Site
    • Las Vegas, Nevada, United States, 89102
      • Novo Nordisk Investigational Site
  • New Hampshire
    • Nashua, New Hampshire, United States, 03063
      • Novo Nordisk Investigational Site
  • New Jersey
    • Flemington, New Jersey, United States, 08822-5763
      • Novo Nordisk Investigational Site
    • Toms River, New Jersey, United States, 08755-8050
      • Novo Nordisk Investigational Site
    • Toms River, New Jersey, United States, 08753-2975
      • Novo Nordisk Investigational Site
  • New York
    • Albany, New York, United States, 12206
      • Novo Nordisk Investigational Site
    • Bronx, New York, United States, 10461
      • Novo Nordisk Investigational Site
    • Northport, New York, United States, 11768
      • Novo Nordisk Investigational Site
    • Syracuse, New York, United States, 13210
      • Novo Nordisk Investigational Site
    • West Seneca, New York, United States, 14224
      • Novo Nordisk Investigational Site
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Novo Nordisk Investigational Site
    • Asheville, North Carolina, United States, 28801
      • Novo Nordisk Investigational Site
    • Burlington, North Carolina, United States, 27215
      • Novo Nordisk Investigational Site
    • Chapel Hill, North Carolina, United States, 27517
      • Novo Nordisk Investigational Site
    • Charlotte, North Carolina, United States, 28277
      • Novo Nordisk Investigational Site
    • Greensboro, North Carolina, United States, 27408
      • Novo Nordisk Investigational Site
    • Greenville, North Carolina, United States, 27834
      • Novo Nordisk Investigational Site
    • Morehead City, North Carolina, United States, 28557
      • Novo Nordisk Investigational Site
    • Shelby, North Carolina, United States, 28152
      • Novo Nordisk Investigational Site
    • Statesville, North Carolina, United States, 28625
      • Novo Nordisk Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Novo Nordisk Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Novo Nordisk Investigational Site
    • Cincinnati, Ohio, United States, 45242
      • Novo Nordisk Investigational Site
    • Cincinnati, Ohio, United States, 45224
      • Novo Nordisk Investigational Site
    • Cincinnati, Ohio, United States, 45242-4494
      • Novo Nordisk Investigational Site
    • Cleveland, Ohio, United States, 44113
      • Novo Nordisk Investigational Site
    • Columbus, Ohio, United States, 43213
      • Novo Nordisk Investigational Site
    • Franklin, Ohio, United States, 45005
      • Novo Nordisk Investigational Site
    • Kettering, Ohio, United States, 45429
      • Novo Nordisk Investigational Site
    • Mason, Ohio, United States, 45040-6815
      • Novo Nordisk Investigational Site
    • Maumee, Ohio, United States, 43537
      • Novo Nordisk Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Novo Nordisk Investigational Site
    • Bridgeville, Pennsylvania, United States, 15017
      • Novo Nordisk Investigational Site
    • Norristown, Pennsylvania, United States, 19401
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19152
      • Novo Nordisk Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15224-2215
      • Novo Nordisk Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15235
      • Novo Nordisk Investigational Site
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Novo Nordisk Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29201-2970
      • Novo Nordisk Investigational Site
    • Greer, South Carolina, United States, 29651
      • Novo Nordisk Investigational Site
    • Pelzer, South Carolina, United States, 29669
      • Novo Nordisk Investigational Site
    • Simpsonville, South Carolina, United States, 29681
      • Novo Nordisk Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • Novo Nordisk Investigational Site
    • Taylors, South Carolina, United States, 29687
      • Novo Nordisk Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Novo Nordisk Investigational Site
    • Chattanooga, Tennessee, United States, 37411
      • Novo Nordisk Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • Novo Nordisk Investigational Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75390-9302
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75246
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75251
      • Novo Nordisk Investigational Site
    • DeSoto, Texas, United States, 75115
      • Novo Nordisk Investigational Site
    • Fort Worth, Texas, United States, 76113
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77074
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77095
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77004-7000
      • Novo Nordisk Investigational Site
    • Irving, Texas, United States, 75061-2210
      • Novo Nordisk Investigational Site
    • Killeen, Texas, United States, 76543-5600
      • Novo Nordisk Investigational Site
    • Lubbock, Texas, United States, 79423
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78215
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78224
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77478
      • Novo Nordisk Investigational Site
  • Utah
    • Ogden, Utah, United States, 84403
      • Novo Nordisk Investigational Site
    • Saint George, Utah, United States, 84790
      • Novo Nordisk Investigational Site
    • Salt Lake City, Utah, United States, 84107
      • Novo Nordisk Investigational Site
  • Virginia
    • Burke, Virginia, United States, 22015
      • Novo Nordisk Investigational Site
    • Manassas, Virginia, United States, 20110
      • Novo Nordisk Investigational Site
    • Newport News, Virginia, United States, 23606
      • Novo Nordisk Investigational Site
    • Virginia Beach, Virginia, United States, 23462
      • Novo Nordisk Investigational Site
  • Washington
    • Spokane, Washington, United States, 99208
      • Novo Nordisk Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with type 2 diabetes
• HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
• Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)
• Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerated dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening
• Body Mass Index (BMI) maximum 40 kg/m^2

Exclusion Criteria:

• Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)
• Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial
• Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
• Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
• Screening calcitonin at least 50 ng/L
• Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
• Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
• Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)
• Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
• History of chronic pancreatitis or idiopathic acute pancreatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDeg	Drug: insulin degludec; Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.
Experimental: IDegLira	Drug: insulin degludec/liraglutide; Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.
Experimental: Lira	Drug: liraglutide; Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.	Values of mean change in HbA1c.	Week 0, week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Body Weight at Week 26	Values of mean change in body weight.	Week 0, Week 26
Number of Hypoglycaemic Episodes	Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.	Weeks 0-26
Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test	Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.	Week 0, Week 26
Mean Actual Daily Insulin Dose	Mean of the actual doses recorded at visit 28 (Week 26).	Week 26

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.
• Holst JJ, Buse JB, Rodbard HW, Linjawi S, Woo VC, Boesgaard TW, Kvist K, Gough SC. IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test. J Diabetes Sci Technol. 2015 Oct 6;10(2):389-97. doi: 10.1177/1932296815610124.
• Vilsboll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376-0.
• Gough SC, Bode B, Woo V, Rodbard HW, Linjawi S, Poulsen P, Damgaard LH, Buse JB; NN9068-3697 (DUAL-I) trial investigators. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):885-93. doi: 10.1016/S2213-8587(14)70174-3. Epub 2014 Sep 1.
• Gough SC, Bode BW, Woo VC, Rodbard HW, Linjawi S, Zacho M, Reiter PD, Buse JB. One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial. Diabetes Obes Metab. 2015 Oct;17(10):965-73. doi: 10.1111/dom.12498. Epub 2015 Jul 1.
• Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14.
• King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsboll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges. Diabetes Technol Ther. 2017 Apr;19(4):255-264. doi: 10.1089/dia.2016.0405. Epub 2017 Mar 10.
• Norwood P, Chen R, Jaeckel E, Lingvay I, Jarlov H, Lehmann L, Heller S. Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Diabetes Obes Metab. 2017 Nov;19(11):1562-1569. doi: 10.1111/dom.12972. Epub 2017 Jul 10.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2011
• Primary Completion (Actual): May 24, 2012
• Study Completion (Actual): November 22, 2012

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimate): April 15, 2011

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 16, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Liraglutide; Xultophy
• Other Study ID Numbers: NN9068-3697; U1111-1119-1174 (Other Identifier: WHO); 2010-021560-15 (EudraCT Number)