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)
6. ledna 2022 aktualizováno: 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).
Přehled studie
Postavení
Postavení
Dokončeno
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Aktuální)
Zápis
1264
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Caba, Argentina, C1060ABA
- Novo Nordisk Investigational Site
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Caba, Argentina, C1440AAD
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Cordoba, Argentina, 5000
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Córdoba, Argentina, 5008
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Kozloduy, Bulharsko, 3320
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Razgrad, Bulharsko, 7200
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Sofia, Bulharsko, 1233
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Sofia, Bulharsko, 1618
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Karlovac, Chorvatsko, 47000
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Osijek, Chorvatsko, 31 000
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Varazdin, Chorvatsko, 42 000
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Zagreb, Chorvatsko, 10 000
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Catanzaro, Itálie, 88100
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Chieti, Itálie, 66100
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Cittadella (PD), Itálie, 35013
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Milano (MI), Itálie, 20132
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Olbia, Itálie, 07026
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Palermo, Itálie, 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, Korejská republika, 14647
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Daegu, Korejská republika, 42472
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Seongnam-si, Korejská republika, 463-707
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Seoul, Korejská republika, 02447
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Seoul, Korejská republika, 03080
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Seoul, Korejská republika, 04516
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Seoul, Korejská republika, 06351
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Seoul, Korejská republika, 08308
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Seoul, Korejská republika, 137-701
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Wonju, Korejská republika, 26426
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Dresden, Německo, 01219
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Essen, Německo, 45136
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Falkensee, Německo, 14612
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Lingen, Německo, 49808
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Münster, Německo, 48145
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Saint Ingbert-Oberwürzbach, Německo, 66386
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Schweinfurt, Německo, 97421
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Bialystok, Polsko, 15-435
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Skorzewo, Polsko, 60-185
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Warsaw, Polsko, 00-465
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Warsaw, Polsko, 02-793
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Warszawa, Polsko, 02-507
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Wroclaw, Polsko, 50-381
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Ponce, Portoriko, 00716
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Brasov, Rumunsko, 500101
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Brasov, Rumunsko, 500283
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Bucharest, Rumunsko, 13682
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Maramures
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Baia Mare, Maramures, Rumunsko, 430222
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Mures
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Tirgu Mures, Mures, Rumunsko, 540142
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Timis
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Timisoara, Timis, Rumunsko, 300125
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Arkhangelsk, Ruská Federace, 163045
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Kazan, Ruská Federace, 420073
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Moscow, Ruská Federace, 123448
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Penza, Ruská Federace, 440026
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Saint Petersburg, Ruská Federace, 194291
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Saint-Petersburg, Ruská Federace, 194356
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Tumen, Ruská Federace, 625023
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Voronezh, Ruská Federace, 394018
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Kosice, Slovensko, 040 01
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Kysucke Nove Mesto, Slovensko, 024 01
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Lubochna, Slovensko, 03491
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Lucenec, Slovensko, 984 01
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Zilina, Slovensko, 01001
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California
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Concord, California, Spojené státy, 94520
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Fresno, California, Spojené státy, 93720
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Fullerton, California, Spojené státy, 92835
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Lancaster, California, Spojené státy, 93534
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Norco, California, Spojené státy, 92860
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Sacramento, California, Spojené státy, 95821
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Ventura, California, Spojené státy, 93003
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Walnut Creek, California, Spojené státy, 94598
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Colorado
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Denver, Colorado, Spojené státy, 80246
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Golden, Colorado, Spojené státy, 80401
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Connecticut
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Waterbury, Connecticut, Spojené státy, 06708
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Florida
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Boynton Beach, Florida, Spojené státy, 33472
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Bradenton, Florida, Spojené státy, 34201
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Fort Lauderdale, Florida, Spojené státy, 33312
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Miami, Florida, Spojené státy, 33174
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Tampa, Florida, Spojené státy, 33634
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Georgia
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Alpharetta, Georgia, Spojené státy, 30022
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Lawrenceville, Georgia, Spojené státy, 30046
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Roswell, Georgia, Spojené státy, 30076
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Hawaii
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Honolulu, Hawaii, Spojené státy, 96814
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Illinois
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Chicago, Illinois, Spojené státy, 60611
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Peoria, Illinois, Spojené státy, 61603
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Springfield, Illinois, Spojené státy, 62711
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Indiana
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Valparaiso, Indiana, Spojené státy, 46383
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Iowa
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West Des Moines, Iowa, Spojené státy, 50266
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Kansas
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Topeka, Kansas, Spojené státy, 66606
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Kentucky
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Lexington, Kentucky, Spojené státy, 40503
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Lexington, Kentucky, Spojené státy, 40502
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Maryland
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Rockville, Maryland, Spojené státy, 20852
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Massachusetts
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Waltham, Massachusetts, Spojené státy, 02453
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Worcester, Massachusetts, Spojené státy, 01655
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Nevada
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Henderson, Nevada, Spojené státy, 89052-2649
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Las Vegas, Nevada, Spojené státy, 89148
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New Hampshire
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Nashua, New Hampshire, Spojené státy, 03063
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New York
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Northport, New York, Spojené státy, 11768
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West Seneca, New York, Spojené státy, 14224
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North Carolina
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Asheville, North Carolina, Spojené státy, 28803
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Chapel Hill, North Carolina, Spojené státy, 27514
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Ohio
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Mentor, Ohio, Spojené státy, 44060
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104-5020
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19140
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South Carolina
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Greenville, South Carolina, Spojené státy, 29605-4254
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37404
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Chattanooga, Tennessee, Spojené státy, 37411
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Nashville, Tennessee, Spojené státy, 37212
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Texas
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Amarillo, Texas, Spojené státy, 79106
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Austin, Texas, Spojené státy, 78731
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Austin, Texas, Spojené státy, 78749
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Beaumont, Texas, Spojené státy, 77701
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Dallas, Texas, Spojené státy, 75230
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Dallas, Texas, Spojené státy, 75226
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Dallas, Texas, Spojené státy, 75231
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Longview, Texas, Spojené státy, 75605
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Pearland, Texas, Spojené státy, 77584
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Round Rock, Texas, Spojené státy, 78681
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Utah
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Ogden, Utah, Spojené státy, 84405
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Vermont
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Bennington, Vermont, Spojené státy, 05201
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South Burlington, Vermont, Spojené státy, 05403
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Virginia
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Chesapeake, Virginia, Spojené státy, 23321
- Novo Nordisk Investigational Site
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Winchester, Virginia, Spojené státy, 22601-3834
- Novo Nordisk Investigational Site
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Washington
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Olympia, Washington, Spojené státy, 98502
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Seattle, Washington, Spojené státy, 98105
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Spokane, Washington, Spojené státy, 99201
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Wisconsin
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Green Bay, Wisconsin, Spojené státy, 54303
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Belgrade, Srbsko, 11000
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Kragujevac, Srbsko, 34000
- Novo Nordisk Investigational Site
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Nis, Srbsko, 18000
- Novo Nordisk Investigational Site
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Novi Sad, Srbsko, 21000
- Novo Nordisk Investigational Site
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Zajecar, Srbsko, 19000
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Dnipro, Ukrajina, 49038
- Novo Nordisk Investigational Site
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Kharkiv, Ukrajina, 61000
- Novo Nordisk Investigational Site
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Kyiv, Ukrajina, 03049
- Novo Nordisk Investigational Site
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Lviv, Ukrajina, 79010
- Novo Nordisk Investigational Site
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Ternopil, Ukrajina, 46002
- Novo Nordisk Investigational Site
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Vinnytsia, Ukrajina, 21010
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Hradec Kralove, Česko, 500 05
- Novo Nordisk Investigational Site
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Plzen, Česko, 30100
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Plzen, Česko, 32600
- Novo Nordisk Investigational Site
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Trutnov, Česko, 541 01
- Novo Nordisk Investigational Site
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Athens, Řecko, GR-11527
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Athens, Řecko, 115 25
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Ioannina, Řecko, 45500
- Novo Nordisk Investigational Site
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Larissa, Řecko, GR-41110
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Thessaloniki, Řecko, GR-54636
- Novo Nordisk Investigational Site
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Thessaloniki, Řecko, GR-57001
- Novo Nordisk Investigational Site
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Thessaloniki, Řecko, GR-54642
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Thessaloniki, Řecko, GR-54643
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Alcobendas, Španělsko, 28100
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Almería, Španělsko, 04001
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Girona, Španělsko, 17007
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La Coruña, Španělsko, 15006
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Pozuelo de Alarcon, Španělsko, 28223
- Novo Nordisk Investigational Site
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Sabadell, Španělsko, 08208
- Novo Nordisk Investigational Site
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Sevilla, Španělsko, 41010
- Novo Nordisk Investigational Site
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Sevilla, Španělsko, 41003
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Faster aspart + insulin degludec with or without metformin
|
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
|
|
Aktivní komparátor: NovoRapid/NovoLog + insulin degludec with or without metformin
|
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.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
Časové okno: Week 0, week 16
|
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.
|
Week 0, week 16
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in 1-hour PPG Increment
Časové okno: 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
|
|
Change From Baseline in 1,5-anhydroglucitol
Časové okno: 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
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Časové okno: 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
|
|
Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
Časové okno: 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
|
|
Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)
Časové okno: 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.
|
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])
Časové okno: 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.
|
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)
Časové okno: 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.
|
Week 0, week 16
|
|
Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile
Časové okno: 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.
|
Week 0, week 16
|
|
Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
19. září 2017
Primární dokončení (Aktuální)
Primární dokončení
7. ledna 2019
Dokončení studie (Aktuální)
Dokončení studie
29. ledna 2019
Termíny zápisu do studia
První předloženo
První předloženo
29. srpna 2017
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
29. srpna 2017
První zveřejněno (Aktuální)
První zveřejněno
31. srpna 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
11. ledna 2022
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. ledna 2022
Naposledy ověřeno
Naposledy ověřeno
1. ledna 2022
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Poruchy metabolismu glukózy
- Metabolické choroby
- Onemocnění endokrinního systému
- Diabetes Mellitus
- Diabetes mellitus, typ 2
- Hypoglykemická činidla
- Fyziologické účinky léků
- Inzulín
- Inzulin, Globin Zinek
- Inzulin Aspart
- Inzulín, dlouhodobě působící
- Inzulin degludek, kombinace léků inzulin aspart
- Metformin
Další identifikační čísla studie
Další identifikační čísla studie
- NN1218-4113
- U1111-1180-0636 (Jiný identifikátor: World Health Organization (WHO))
- 2016-000878-38 (Identifikátor registru: European Medicines Agency (EudraCT))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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Klinické studie na Diabetes mellitus, typ 2
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NCT07548957Zatím nenabíráme
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NCT07146516NáborSticklerův syndrom typu 2 | Sticklerův syndrom typu 1
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NCT07377448DokončenoDiabetes mellitus, typ 2 | Diabetes Mellitus, typ 2 léčený inzulínem
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NCT00901043DokončenoDIABETES MELLITUS TYP 2
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NCT01624116Dokončeno
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NCT06573905Zatím nenabírámeDiabetes mellitus, typ 1 | Diabetes, autoimunita | Diabetes typu 2 | Diabetes; Nástup v dospělosti
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NCT06692153StaženoCukrovka typu 2 | Diabetes mellitus 2. typu (T2DM) | T2DM (diabetes mellitus 2. typu) | T2D | T2DM | Typ 2 DM | T2DM s nedostatečnou kontrolou glykémie
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NCT07471750Zatím nenabírámeRutinní screeningová mamografie
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NCT03195153NeznámýDiabetes Mellitus Typ 2 Reaktivita krevních destiček Statin