The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes (ADJUNCT ONE™)
16 gennaio 2017 aggiornato da: Novo Nordisk A/S
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial
This trial is conducted globally.
The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes.
The total trial duration per subject is approximately 58 weeks.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1398
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Caba, Argentina, C1440AAD
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Caba, Argentina, C1118AAT
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Capital Federal, Argentina, 1405
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Córdoba, Argentina, X5016KEH
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Mendoza, Argentina, 5500
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Morón, Argentina, B1708IFF
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New South Wales
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Broadmeadow, New South Wales, Australia, 2292
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
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Keswick, South Australia, Australia, 5035
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Victoria
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Melbourne, Victoria, Australia, 3004
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Parkville, Victoria, Australia, 3050
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Arlon, Belgio, 6700
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Edegem, Belgio, 2650
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Leuven, Belgio, 3000
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Liège, Belgio, 4000
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Quebec, Canada, G1V 4G2
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Quebec, Canada, G1V 4G5
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Alberta
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Edmonton, Alberta, Canada, T6G 2E1
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
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Cambridge, Ontario, Canada, N1R 7L6
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London, Ontario, Canada, N6A 4V2
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Mississauga, Ontario, Canada, L5M 2V8
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Oakville, Ontario, Canada, L6M 1M1
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Thornhill, Ontario, Canada, L4J 8L7
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Toronto, Ontario, Canada, M4G 3E8
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Toronto, Ontario, Canada, M5C 2T2
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Toronto, Ontario, Canada, M5T 3L9
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Quebec
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Montreal, Quebec, Canada, H2W 1R7
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Sherbrooke, Quebec, Canada, J1G 5K2
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Kazan, Federazione Russa, 420012
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Kazan, Federazione Russa, 420073
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Penza, Federazione Russa, 440026
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Saratov, Federazione Russa, 410012
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Volgograd, Federazione Russa, 400138
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Helsinki, Finlandia, 00250
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Helsinki, Finlandia, 00029
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Pori, Finlandia, 28500
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Seinäjoki, Finlandia, 60220
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Seinäjoki, Finlandia, 60510
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Tampere, Finlandia, 33520
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Turku, Finlandia, FI-20520
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Besancon, Francia, 25030
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Brest, Francia, 29609
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Caen, Francia, 14033
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Corbeil Essonnes, Francia, 91106
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DIJON cedex, Francia, 21079
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Le Creusot, Francia, 71200
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Narbonne, Francia, 11108
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Paris, Francia, 75877
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Pointe à Pitre, Francia, 97159
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Poitiers, Francia, 86000
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Saint Herblain, Francia, 44800
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Saint Priest en Jarez, Francia, 42270
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Venissieux, Francia, 69200
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Eisenach, Germania, 99817
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Essen, Germania, 45219
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Hamburg, Germania, 22607
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Hamburg, Germania, 21073
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Hohenmölsen, Germania, 06679
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Marburg, Germania, 35039
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Münster, Germania, 48145
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Pohlheim, Germania, 35415
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Rehlingen-Siersburg, Germania, 66780
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St. Ingbert, Germania, 66386
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Dublin, Irlanda, DUBLIN 15
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Dublin, Irlanda, DUBLIN 4
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Dublin, Irlanda, DUBLIN 7
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Dublin 9, Irlanda
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Galway, Irlanda
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Haifa, Israele, 31096
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Holon, Israele, 58100
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Jerusalem, Israele, 91120
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Jerusalem, Israele, 93106
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Petah Tikva, Israele, 49202
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Rishon Le Zion, Israele, 75650
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Bergen, Norvegia, 5021
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Gjettum, Norvegia, 1346
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Hamar, Norvegia, 2318
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Kongsvinger, Norvegia, 2226
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Stavanger, Norvegia, 4011
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Amsterdam, Olanda, 1105 AZ
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Den Haag, Olanda, 2512 VA
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Hoogeveen, Olanda, 7909 AA
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Leiden, Olanda, 2333 ZA
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Nijmegen, Olanda, 6525 GA
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Rotterdam, Olanda, 3011 TA
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Venlo, Olanda, 5912 BL
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Lublin, Polonia, 20-044
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Pulawy, Polonia, 24-100
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Warszawa, Polonia, 00-911
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Warszawa, Polonia, 03-242
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Zabrze, Polonia, 41-800
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Blackburn, Regno Unito, BB2 3HH
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Bristol, Regno Unito, BS10 5NB
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Durham, Regno Unito, DH11 5TW
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Edgbaston, Birmingham, Regno Unito, B15 2TH
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Edinburgh, Regno Unito, EH4 2XU
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Middlesbrough, Regno Unito, TS4 3BW
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Plymouth, Regno Unito, PL6 8BQ
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Southall, Regno Unito, UB1 3HW
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St Helens, Regno Unito, WA9 3DA
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Stevenage, Regno Unito, SG1 4AB
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
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California
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Concord, California, Stati Uniti, 94520
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Encino, California, Stati Uniti, 91436
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Escondido, California, Stati Uniti, 92025
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Huntington Beach, California, Stati Uniti, 92648
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La Mesa, California, Stati Uniti, 91942
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Lancaster, California, Stati Uniti, 93534
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Monterey, California, Stati Uniti, 93940
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San Mateo, California, Stati Uniti, 94401
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San Ramon, California, Stati Uniti, 94583
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Walnut Creek, California, Stati Uniti, 94598
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Colorado
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Denver, Colorado, Stati Uniti, 80209
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Florida
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Ft. Lauderdale, Florida, Stati Uniti, 33312
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Hialeah, Florida, Stati Uniti, 33012
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Jacksonville, Florida, Stati Uniti, 32258
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Tampa, Florida, Stati Uniti, 33619
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Georgia
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Atlanta, Georgia, Stati Uniti, 30318
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Atlanta, Georgia, Stati Uniti, 30308-2253
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Marietta, Georgia, Stati Uniti, 30060
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Roswell, Georgia, Stati Uniti, 30076
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Savannah, Georgia, Stati Uniti, 31405
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Idaho
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Idaho Falls, Idaho, Stati Uniti, 83404-7596
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46254
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Iowa
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Council Bluffs, Iowa, Stati Uniti, 51501
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Iowa City, Iowa, Stati Uniti, 52242
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Kansas
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Topeka, Kansas, Stati Uniti, 66606
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Louisiana
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Metarie, Louisiana, Stati Uniti, 70006
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Maryland
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Baltimore, Maryland, Stati Uniti, 21229
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55416
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Missouri
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Chesterfield, Missouri, Stati Uniti, 63017
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Springfield, Missouri, Stati Uniti, 65807
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St. Charles, Missouri, Stati Uniti, 63303
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St. Louis, Missouri, Stati Uniti, 63110-1020
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St. Peters, Missouri, Stati Uniti, 63376
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Montana
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Billings, Montana, Stati Uniti, 59101
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Butte, Montana, Stati Uniti, 59701
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New Jersey
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Lawrenceville, New Jersey, Stati Uniti, 08648
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New York
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Albany, New York, Stati Uniti, 12206
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Mineola, New York, Stati Uniti, 11501
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New York, New York, Stati Uniti, 10029
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New York, New York, Stati Uniti, 10032
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Staten Island, New York, Stati Uniti, 10301
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Syracuse, New York, Stati Uniti, 13210
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North Carolina
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Greensboro, North Carolina, Stati Uniti, 27408
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Morehead City, North Carolina, Stati Uniti, 28557
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Ohio
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Mentor, Ohio, Stati Uniti, 44060
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15224-2215
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Upper Darby, Pennsylvania, Stati Uniti, 19082
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South Carolina
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Greer, South Carolina, Stati Uniti, 29651
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Myrtle Beach, South Carolina, Stati Uniti, 29572
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Summerville, South Carolina, Stati Uniti, 29485
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37411
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Chattanooga, Tennessee, Stati Uniti, 37404-1192
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Memphis, Tennessee, Stati Uniti, 38119-3821
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Nashville, Tennessee, Stati Uniti, 37212
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Nashville, Tennessee, Stati Uniti, 37203
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Texas
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Amarillo, Texas, Stati Uniti, 79106
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Dallas, Texas, Stati Uniti, 75230
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Dallas, Texas, Stati Uniti, 75231
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Dallas, Texas, Stati Uniti, 75246
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El Paso, Texas, Stati Uniti, 79912
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Round Rock, Texas, Stati Uniti, 78681
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Sugar Land, Texas, Stati Uniti, 77478
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Utah
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Salt Lake City, Utah, Stati Uniti, 84102
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Vermont
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Bennington, Vermont, Stati Uniti, 05201
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Virginia
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Norfolk, Virginia, Stati Uniti, 23510
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Washington
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Federal Way, Washington, Stati Uniti, 98003
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Spokane, Washington, Stati Uniti, 99208
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53209
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Milwaukee, Wisconsin, Stati Uniti, 53226
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Göteborg, Svezia, 413 45
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Malmö, Svezia, 205 02
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Stockholm, Svezia, 141 86
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Stockholm, Svezia, 112 81
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Kharkov, Ucraina, 61058
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Kharkov, Ucraina, 61070
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Kiev, Ucraina, 04114
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Poltava, Ucraina, 36011
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Zhytomir, Ucraina, 10002
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- - Informed consent obtained
- - Type 1 diabetes mellitus for 12 months or longer
- - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer
- - Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator
- - HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
- - Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits
Exclusion Criteria:
- - Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors
- - Use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.Premix insulin is not allowed
- - Known proliferative retinopathy or maculopathy requiring acute treatment
- - Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
- - Uncontrolled/ untreated blood pressure at screening above 160 mmHg for systolic or above 100 mmHg for diastolic
- - History of acute or chronic pancreatitis
- - Screening calcitonin value equal to or above 50 ng/L
- - Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)
- - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Liraglutide 1,8 mg + insulina
|
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks).
Administered subcutaneously (s.c., under the skin) once daily.
|
|
Sperimentale: Liraglutide 1,2 mg + insulina
|
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks).
Administered subcutaneously (s.c., under the skin) once daily.
|
|
Sperimentale: Liraglutide 0,6 mg + insulina
|
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks).
Administered subcutaneously (s.c., under the skin) once daily.
|
|
Comparatore placebo: Liraglutide placebo 0.6 mg + insulin
|
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks).
Administered subcutaneously (s.c., under the skin) once daily.
|
|
Comparatore placebo: Liraglutide placebo 1.2 mg + insulin
|
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks).
Administered subcutaneously (s.c., under the skin) once daily.
|
|
Comparatore placebo: Liraglutide placebo 1.8 mg + insulin
|
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks).
Administered subcutaneously (s.c., under the skin) once daily.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Lasso di tempo: Week 0, week 52
|
Change from baseline in HbA1c at week 52.
Missing values were handled by using a mixed model for repeated measurements (MMRM).
|
Week 0, week 52
|
|
Change From Baseline in Body Weight
Lasso di tempo: Week 0, week 52
|
Change from baseline in body weight at week 52.
Missing values were handled by using a MMRM.
|
Week 0, week 52
|
|
Change From Baseline in Total Daily Insulin Dose
Lasso di tempo: Week 0, week 52
|
Change from baseline in total daily insulin dose at week 52.
Change from baseline was represented in terms of ratio to baseline for insulin dose i.e.
Total daily insulin dose at week 52/total daily insulin dose at baseline.
Missing values were handled by using a MMRM.
|
Week 0, week 52
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Lasso di tempo: Weeks 0-52
|
This is a confirmatory secondary endpoint.
Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.
OR 2) Self-monitoring of plasma glucose value of <3.1 mmol/L, with symptoms consistent with hypoglycaemia.
A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days.
|
Weeks 0-52
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Dejgaard TF, von Scholten BJ, Christiansen E, Kreiner FF, Bardtrum L, von Herrath M, Mathieu C, Madsbad S; ADJUNCT ONE and ADJUNCT TWO Investigators. Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Diabetes Obes Metab. 2021 Dec;23(12):2752-2762. doi: 10.1111/dom.14532. Epub 2021 Sep 28. Erratum In: Diabetes Obes Metab. 2022 Nov;24(11):2280.
- Mathieu C, Zinman B, Hemmingsson JU, Woo V, Colman P, Christiansen E, Linder M, Bode B; ADJUNCT ONE Investigators. Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. Diabetes Care. 2016 Oct;39(10):1702-10. doi: 10.2337/dc16-0691. Epub 2016 Aug 9.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2013
Completamento primario (Effettivo)
1 giugno 2015
Completamento dello studio (Effettivo)
1 giugno 2015
Date di iscrizione allo studio
Primo inviato
17 aprile 2013
Primo inviato che soddisfa i criteri di controllo qualità
17 aprile 2013
Primo Inserito (Stima)
22 aprile 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 marzo 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 gennaio 2017
Ultimo verificato
1 gennaio 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie del sistema endocrino
- Diabete mellito
- Diabete mellito, tipo 1
- Agenti ipoglicemizzanti
- Effetti fisiologici delle droghe
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Incretine
- Liraglutide
Altri numeri di identificazione dello studio
- NN9211-3919
- 2012-003580-21 (Numero EudraCT)
- U1111-1133-0590 (Altro identificatore: WHO)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .