Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes (onset 9)
torstai 6. tammikuuta 2022 päivittänyt: Novo Nordisk A/S
Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Type 2 Diabetes (Onset® 9)
The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe).
Fast-acting insulin aspart will be tested to see how well it works and if it is safe.
Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance.
Both medicines will be taken together with insulin degludec.
Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens).
The study will last for about 8 months (34 weeks).
Tutkimuksen yleiskatsaus
Tila
Tila
Valmis
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
1264
Vaihe
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Caba, Argentiina, C1060ABA
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Caba, Argentiina, C1440AAD
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Cordoba, Argentiina, 5000
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Córdoba, Argentiina, 5008
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Kozloduy, Bulgaria, 3320
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Razgrad, Bulgaria, 7200
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1618
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Alcobendas, Espanja, 28100
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Almería, Espanja, 04001
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Girona, Espanja, 17007
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La Coruña, Espanja, 15006
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Pozuelo de Alarcon, Espanja, 28223
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Sabadell, Espanja, 08208
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Sevilla, Espanja, 41010
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Sevilla, Espanja, 41003
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Catanzaro, Italia, 88100
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Chieti, Italia, 66100
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Cittadella (PD), Italia, 35013
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Milano (MI), Italia, 20132
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Olbia, Italia, 07026
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Palermo, Italia, 90129
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Alberta
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Edmonton, Alberta, Kanada, T6G 2E1
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British Columbia
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Victoria, British Columbia, Kanada, V8V 4A1
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 2Y9
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Ontario
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Barrie, Ontario, Kanada, L4N 7L3
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Concord, Ontario, Kanada, L4K 4M2
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Etobicoke, Ontario, Kanada, M9R 4E1
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Hamilton, Ontario, Kanada, L8M 1K7
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Newmarket, Ontario, Kanada, L3Y 5G8
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Thunder Bay, Ontario, Kanada, P7A 4V7
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Toronto, Ontario, Kanada, M4G 3E8
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Quebec
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Montreal, Quebec, Kanada, H4T 1Z9
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Bucheon, Korean tasavalta, 14647
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Daegu, Korean tasavalta, 42472
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Seongnam-si, Korean tasavalta, 463-707
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Seoul, Korean tasavalta, 02447
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Seoul, Korean tasavalta, 03080
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Seoul, Korean tasavalta, 04516
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Seoul, Korean tasavalta, 06351
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Seoul, Korean tasavalta, 08308
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Seoul, Korean tasavalta, 137-701
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Wonju, Korean tasavalta, 26426
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Athens, Kreikka, GR-11527
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Athens, Kreikka, 115 25
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Ioannina, Kreikka, 45500
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Larissa, Kreikka, GR-41110
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Thessaloniki, Kreikka, GR-54636
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Thessaloniki, Kreikka, GR-57001
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Thessaloniki, Kreikka, GR-54642
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Thessaloniki, Kreikka, GR-54643
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Karlovac, Kroatia, 47000
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Osijek, Kroatia, 31 000
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Varazdin, Kroatia, 42 000
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Zagreb, Kroatia, 10 000
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Ponce, Puerto Rico, 00716
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Bialystok, Puola, 15-435
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Skorzewo, Puola, 60-185
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Warsaw, Puola, 00-465
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Warsaw, Puola, 02-793
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Warszawa, Puola, 02-507
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Wroclaw, Puola, 50-381
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Brasov, Romania, 500101
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Brasov, Romania, 500283
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Bucharest, Romania, 13682
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Maramures
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Baia Mare, Maramures, Romania, 430222
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Mures
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Tirgu Mures, Mures, Romania, 540142
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Timis
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Timisoara, Timis, Romania, 300125
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Dresden, Saksa, 01219
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Essen, Saksa, 45136
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Falkensee, Saksa, 14612
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Lingen, Saksa, 49808
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Münster, Saksa, 48145
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Saint Ingbert-Oberwürzbach, Saksa, 66386
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Schweinfurt, Saksa, 97421
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Belgrade, Serbia, 11000
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Kragujevac, Serbia, 34000
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Nis, Serbia, 18000
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Novi Sad, Serbia, 21000
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Zajecar, Serbia, 19000
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Kosice, Slovakia, 040 01
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Kysucke Nove Mesto, Slovakia, 024 01
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Lubochna, Slovakia, 03491
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Lucenec, Slovakia, 984 01
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Zilina, Slovakia, 01001
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Hradec Kralove, Tšekki, 500 05
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Plzen, Tšekki, 30100
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Plzen, Tšekki, 32600
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Trutnov, Tšekki, 541 01
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Dnipro, Ukraina, 49038
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Kharkiv, Ukraina, 61000
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Kyiv, Ukraina, 03049
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Lviv, Ukraina, 79010
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Ternopil, Ukraina, 46002
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Vinnytsia, Ukraina, 21010
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Arkhangelsk, Venäjän federaatio, 163045
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Kazan, Venäjän federaatio, 420073
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Moscow, Venäjän federaatio, 123448
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Penza, Venäjän federaatio, 440026
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Saint Petersburg, Venäjän federaatio, 194291
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Saint-Petersburg, Venäjän federaatio, 194356
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Tumen, Venäjän federaatio, 625023
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Voronezh, Venäjän federaatio, 394018
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California
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Concord, California, Yhdysvallat, 94520
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Fresno, California, Yhdysvallat, 93720
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Fullerton, California, Yhdysvallat, 92835
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Lancaster, California, Yhdysvallat, 93534
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Norco, California, Yhdysvallat, 92860
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Sacramento, California, Yhdysvallat, 95821
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Ventura, California, Yhdysvallat, 93003
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Walnut Creek, California, Yhdysvallat, 94598
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Colorado
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Denver, Colorado, Yhdysvallat, 80246
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Golden, Colorado, Yhdysvallat, 80401
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Connecticut
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Waterbury, Connecticut, Yhdysvallat, 06708
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Florida
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Boynton Beach, Florida, Yhdysvallat, 33472
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Bradenton, Florida, Yhdysvallat, 34201
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Fort Lauderdale, Florida, Yhdysvallat, 33312
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Miami, Florida, Yhdysvallat, 33174
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Tampa, Florida, Yhdysvallat, 33634
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Georgia
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Alpharetta, Georgia, Yhdysvallat, 30022
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Lawrenceville, Georgia, Yhdysvallat, 30046
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Roswell, Georgia, Yhdysvallat, 30076
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Hawaii
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Honolulu, Hawaii, Yhdysvallat, 96814
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Illinois
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Chicago, Illinois, Yhdysvallat, 60611
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Peoria, Illinois, Yhdysvallat, 61603
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Springfield, Illinois, Yhdysvallat, 62711
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Indiana
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Valparaiso, Indiana, Yhdysvallat, 46383
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Iowa
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West Des Moines, Iowa, Yhdysvallat, 50266
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Kansas
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Topeka, Kansas, Yhdysvallat, 66606
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Kentucky
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Lexington, Kentucky, Yhdysvallat, 40503
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Lexington, Kentucky, Yhdysvallat, 40502
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Maryland
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Rockville, Maryland, Yhdysvallat, 20852
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Massachusetts
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Waltham, Massachusetts, Yhdysvallat, 02453
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Worcester, Massachusetts, Yhdysvallat, 01655
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Nevada
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Henderson, Nevada, Yhdysvallat, 89052-2649
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Las Vegas, Nevada, Yhdysvallat, 89148
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New Hampshire
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Nashua, New Hampshire, Yhdysvallat, 03063
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New York
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Northport, New York, Yhdysvallat, 11768
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West Seneca, New York, Yhdysvallat, 14224
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North Carolina
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Asheville, North Carolina, Yhdysvallat, 28803
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Chapel Hill, North Carolina, Yhdysvallat, 27514
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Ohio
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Mentor, Ohio, Yhdysvallat, 44060
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73104-5020
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19140
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South Carolina
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Greenville, South Carolina, Yhdysvallat, 29605-4254
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Tennessee
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Chattanooga, Tennessee, Yhdysvallat, 37404
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Chattanooga, Tennessee, Yhdysvallat, 37411
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Nashville, Tennessee, Yhdysvallat, 37212
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Texas
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Amarillo, Texas, Yhdysvallat, 79106
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Austin, Texas, Yhdysvallat, 78731
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Austin, Texas, Yhdysvallat, 78749
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Beaumont, Texas, Yhdysvallat, 77701
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Dallas, Texas, Yhdysvallat, 75230
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Dallas, Texas, Yhdysvallat, 75226
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Dallas, Texas, Yhdysvallat, 75231
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Longview, Texas, Yhdysvallat, 75605
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Pearland, Texas, Yhdysvallat, 77584
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Round Rock, Texas, Yhdysvallat, 78681
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Utah
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Ogden, Utah, Yhdysvallat, 84405
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Vermont
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Bennington, Vermont, Yhdysvallat, 05201
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South Burlington, Vermont, Yhdysvallat, 05403
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Virginia
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Chesapeake, Virginia, Yhdysvallat, 23321
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Winchester, Virginia, Yhdysvallat, 22601-3834
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Washington
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Olympia, Washington, Yhdysvallat, 98502
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Seattle, Washington, Yhdysvallat, 98105
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Spokane, Washington, Yhdysvallat, 99201
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Wisconsin
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Green Bay, Wisconsin, Yhdysvallat, 54303
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1).
- Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1).
A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily.
Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen.
- Treated with or without oral antidiabetic drugs including extended release formulations.
- HbA1c 7.0-10.0%
(both inclusive) as assessed by central laboratory at screening (Visit 1).
Exclusion Criteria: - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1).
- Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1).
- Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1).
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g.
treatment with orlistat, thyroid hormones, or corticosteroids).
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseiden lukumäärä
2
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Kokeellinen: Faster aspart + insulin degludec with or without metformin
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Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks.
Dose individually adjusted.
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks.
Dose individually adjusted.
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
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Active Comparator: NovoRapid/NovoLog + insulin degludec with or without metformin
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Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks.
Dose individually adjusted.
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks.
Dose individually adjusted.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Glycosylated Haemoglobin (HbA1c)
Aikaikkuna: Week 0, week 16
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Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16.
The endpoint was evaluated based on data from the in-trial observation period.
In-trial observation period was from date of randomisation and until last trial-related participant-site contact.
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Week 0, week 16
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change From Baseline in 1-hour PPG Increment
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
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Change From Baseline in 1,5-anhydroglucitol
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
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Change From Baseline in Fasting Plasma Glucose (FPG)
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
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Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
Aikaikkuna: 16 weeks after randomisation
|
Number of participants reaching HbA1c <7.0% (53 mmol/L) was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
16 weeks after randomisation
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Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)
Aikaikkuna: 16 weeks after randomisation
|
Number of participants reaching HbA1c <7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
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16 weeks after randomisation
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Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test.
The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
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Week 0, week 16
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Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test.
The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.
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Week 0, week 16
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Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
7-9-7 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.
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Week 0, week 16
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Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
|
Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
PPG increment based on the 7-9-7-point profiles were derived separately for PG measurements made at 1 hour after main meals (breakfast, lunch and main evening meal).
PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
|
Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile
Aikaikkuna: Week 0, week 16
|
Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile.
Reported results are fluctuation in the 7-9-7 point SMPG profile from baseline (week 0) after 16 weeks of randomisation (i.e., week 16).
The results are presented as ratio to baseline.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
|
Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements
Aikaikkuna: Week 0, week 16
|
Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value).
Change from baseline in nocturnal increments in SMPG measurements of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
|
Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No)
Aikaikkuna: 16 weeks after randomisation
|
Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation.
Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
16 weeks after randomisation
|
|
Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)
Aikaikkuna: 16 weeks after randomisation
|
Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation.
Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
16 weeks after randomisation
|
|
Total Bolus Insulin Dose: in Units/Day
Aikaikkuna: 16 weeks from randomisation
|
Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
16 weeks from randomisation
|
|
Total Bolus Insulin Dose: in Units/kg/Day
Aikaikkuna: 16 weeks from randomisation
|
Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
16 weeks from randomisation
|
|
Total Basal Insulin Dose: in Units/Day
Aikaikkuna: 16 weeks from randomisation
|
Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
16 weeks from randomisation
|
|
Total Basal Insulin Dose: in Units/kg/Day
Aikaikkuna: 16 weeks from randomisation
|
Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
16 weeks from randomisation
|
|
Individual Meal Insulin Dose: in Units
Aikaikkuna: 16 weeks from randomisation
|
Individual meal time bolus insulin dose (Units) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
16 weeks from randomisation
|
|
Individual Meal Insulin Dose: in Units/kg
Aikaikkuna: 16 weeks from randomisation
|
Individual meal time bolus insulin dose (Units/kg) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
16 weeks from randomisation
|
|
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline
Aikaikkuna: Week 0, week 16
|
Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values are given as ratio to baseline (week 0) after 16 weeks.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
|
Number of Treatment Emergent Adverse Events
Aikaikkuna: Weeks 0-16
|
Number of treatment emergent adverse events were recorded from week 0 to week 16.
The results are based on the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Weeks 0-16
|
|
Number of Treatment Emergent Injection Site Reactions
Aikaikkuna: Weeks 0-16
|
Number of treatment emergent injection site reactions were recorded from week 0 to week 16.
The results are based on the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Weeks 0-16
|
|
Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
Aikaikkuna: Weeks 0-16
|
ADA classification of hypos:
NN classification of hypos:
|
Weeks 0-16
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)
Aikaikkuna: Weeks 0-16
|
Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included).
The results are based on the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Weeks 0-16
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
Aikaikkuna: Weeks 0-16
|
Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included).
The results are based on the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Weeks 0-16
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal
Aikaikkuna: Weeks 0-16
|
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal.
The results are based on the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Weeks 0-16
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal
Aikaikkuna: Weeks 0-16
|
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal.
The results are based on the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Weeks 0-16
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal
Aikaikkuna: Weeks 0-16
|
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal.
The results are based on the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Weeks 0-16
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal
Aikaikkuna: Weeks 0-16
|
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal.
The results are based on the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Weeks 0-16
|
|
Change From Baseline in Physical Examination
Aikaikkuna: Week 0, week 16
|
Participants with physical examination findings, normal, abnormal NCS (non- clinically significant) and abnormal CS (clinically significant) at baseline (week 0) and week 16 presented.
Results are based on the data from the on-treatment observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Results are presented for the following examinations: 1) Cardiovascular system 2) Central & Peripheral nervous system 3) Gastrointestinal system incl.
mouth 4) Head, ears, eyes, nose, throat and neck 5) Musculoskeletal system 6) Respiratory system 7) Skin
|
Week 0, week 16
|
|
Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure
Aikaikkuna: Week 0, week 16
|
Change in vital signs - systolic and diastolic blood pressure from baseline (week 0) was evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Vital Signs: Pulse
Aikaikkuna: Week 0, week 16
|
Change in vital signs - pulse from baseline (week 0) was evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Electrocardiogram (ECG)
Aikaikkuna: Week 0, week 16
|
Changes in electrocardiogram (ECG) from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Fundoscopy/Fundus Photography
Aikaikkuna: Week 0, week 16
|
Changes in fundoscopy/fundus photography from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Haematology - Haematocrit
Aikaikkuna: Week 0, week 16
|
Changes in haematology - haematocrit from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Haematology - Haemoglobin
Aikaikkuna: Week 0, week 16
|
Changes in haematology - haemoglobin from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Haematology - Leukocytes
Aikaikkuna: Week 0, week 16
|
Changes in haematology - leukocytes from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Haematology - Thrombocytes
Aikaikkuna: Week 0, week 16
|
Changes in haematology - thrombocytes from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Haematology - Erythrocytes
Aikaikkuna: Week 0, week 16
|
Changes in haematology - erythrocytes from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - alanine aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Alkaline Phosphatase
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - alkaline phosphatase from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - aspratate aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Albumin
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - albumin from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Creatinine
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - creatinine from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Potassium
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - potassium from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Sodium
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - sodium from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Total Bilirubin
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - total bilirubin from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Biochemistry - Total Protein
Aikaikkuna: Week 0, week 16
|
Changes in biochemistry - total protein from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Body Weight
Aikaikkuna: Week 0, week 16
|
Changes in body weight from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
|
Change From Baseline in Body Mass Index (BMI)
Aikaikkuna: Week 0, week 16
|
Change in the body mass index (BMI) from baseline (week 0) were evaluated after 16 weeks of randomisation.
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
|
Week 0, week 16
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
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Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Lane WS, Favaro E, Rathor N, Jang HC, Kjaersgaard MIS, Oviedo A, Rose L, Senior P, Sesti G, Soto Gonzalez A, Franek E. A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9). Diabetes Care. 2020 Aug;43(8):1710-1716. doi: 10.2337/dc19-2232. Epub 2020 Mar 24.
- Lane W, Favaro E, Jódar E, Kelkar P, Oviedo A, Sivarathinasami R, Senior PA, Sesti G, Franek E. Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial. Diabetes Ther. 2022 Apr;13(4):761-774. doi: 10.1007/s13300-022-01213-3. Epub 2022 Mar 15.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Tiistai 19. syyskuuta 2017
Ensisijainen valmistuminen (Todellinen)
Ensisijainen valmistuminen
Maanantai 7. tammikuuta 2019
Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Tiistai 29. tammikuuta 2019
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Tiistai 29. elokuuta 2017
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 29. elokuuta 2017
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Torstai 31. elokuuta 2017
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Tiistai 11. tammikuuta 2022
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 6. tammikuuta 2022
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Viimeksi vahvistettu
Lauantai 1. tammikuuta 2022
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Glukoosiaineenvaihduntahäiriöt
- Metaboliset sairaudet
- Endokriinisen järjestelmän sairaudet
- Diabetes mellitus
- Diabetes mellitus, tyyppi 2
- Hypoglykeemiset aineet
- Huumeiden fysiologiset vaikutukset
- Insuliini
- Insuliini, Globiini Sinkki
- Aspartinsuliini
- Insuliini, pitkävaikutteinen
- Degludekin insuliini, aspartinsuliinin lääkeyhdistelmä
- Metformiini
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- NN1218-4113
- U1111-1180-0636 (Muu tunniste: World Health Organization (WHO))
- 2016-000878-38 (Rekisterin tunniste: European Medicines Agency (EudraCT))
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IPD-suunnitelman kuvaus
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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