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 gennaio 2022 aggiornato da: 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).
Panoramica dello studio
Stato
Stato
Completato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
1264
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Caba, Argentina, C1060ABA
- Novo Nordisk Investigational Site
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Caba, Argentina, C1440AAD
- Novo Nordisk Investigational Site
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Cordoba, Argentina, 5000
- Novo Nordisk Investigational Site
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Córdoba, Argentina, 5008
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Kozloduy, Bulgaria, 3320
- Novo Nordisk Investigational Site
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Razgrad, Bulgaria, 7200
- Novo Nordisk Investigational Site
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Sofia, Bulgaria, 1233
- Novo Nordisk Investigational Site
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Sofia, Bulgaria, 1618
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Alberta
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Edmonton, Alberta, Canada, T6G 2E1
- Novo Nordisk Investigational Site
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British Columbia
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Victoria, British Columbia, Canada, V8V 4A1
- Novo Nordisk Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Novo Nordisk Investigational Site
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Ontario
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Barrie, Ontario, Canada, L4N 7L3
- Novo Nordisk Investigational Site
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Concord, Ontario, Canada, L4K 4M2
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Etobicoke, Ontario, Canada, M9R 4E1
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Hamilton, Ontario, Canada, L8M 1K7
- Novo Nordisk Investigational Site
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Newmarket, Ontario, Canada, L3Y 5G8
- Novo Nordisk Investigational Site
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Thunder Bay, Ontario, Canada, P7A 4V7
- Novo Nordisk Investigational Site
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Toronto, Ontario, Canada, M4G 3E8
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Quebec
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Montreal, Quebec, Canada, H4T 1Z9
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Hradec Kralove, Cechia, 500 05
- Novo Nordisk Investigational Site
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Plzen, Cechia, 30100
- Novo Nordisk Investigational Site
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Plzen, Cechia, 32600
- Novo Nordisk Investigational Site
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Trutnov, Cechia, 541 01
- Novo Nordisk Investigational Site
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Bucheon, Corea, Repubblica di, 14647
- Novo Nordisk Investigational Site
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Daegu, Corea, Repubblica di, 42472
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Seongnam-si, Corea, Repubblica di, 463-707
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Seoul, Corea, Repubblica di, 02447
- Novo Nordisk Investigational Site
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Seoul, Corea, Repubblica di, 03080
- Novo Nordisk Investigational Site
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Seoul, Corea, Repubblica di, 04516
- Novo Nordisk Investigational Site
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Seoul, Corea, Repubblica di, 06351
- Novo Nordisk Investigational Site
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Seoul, Corea, Repubblica di, 08308
- Novo Nordisk Investigational Site
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Seoul, Corea, Repubblica di, 137-701
- Novo Nordisk Investigational Site
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Wonju, Corea, Repubblica di, 26426
- Novo Nordisk Investigational Site
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Karlovac, Croazia, 47000
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Osijek, Croazia, 31 000
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Varazdin, Croazia, 42 000
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Zagreb, Croazia, 10 000
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Arkhangelsk, Federazione Russa, 163045
- Novo Nordisk Investigational Site
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Kazan, Federazione Russa, 420073
- Novo Nordisk Investigational Site
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Moscow, Federazione Russa, 123448
- Novo Nordisk Investigational Site
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Penza, Federazione Russa, 440026
- Novo Nordisk Investigational Site
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Saint Petersburg, Federazione Russa, 194291
- Novo Nordisk Investigational Site
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Saint-Petersburg, Federazione Russa, 194356
- Novo Nordisk Investigational Site
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Tumen, Federazione Russa, 625023
- Novo Nordisk Investigational Site
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Voronezh, Federazione Russa, 394018
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Dresden, Germania, 01219
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Essen, Germania, 45136
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Falkensee, Germania, 14612
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Lingen, Germania, 49808
- Novo Nordisk Investigational Site
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Münster, Germania, 48145
- Novo Nordisk Investigational Site
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Saint Ingbert-Oberwürzbach, Germania, 66386
- Novo Nordisk Investigational Site
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Schweinfurt, Germania, 97421
- Novo Nordisk Investigational Site
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Athens, Grecia, GR-11527
- Novo Nordisk Investigational Site
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Athens, Grecia, 115 25
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Ioannina, Grecia, 45500
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Larissa, Grecia, GR-41110
- Novo Nordisk Investigational Site
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Thessaloniki, Grecia, GR-54636
- Novo Nordisk Investigational Site
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Thessaloniki, Grecia, GR-57001
- Novo Nordisk Investigational Site
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Thessaloniki, Grecia, GR-54642
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Thessaloniki, Grecia, GR-54643
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Catanzaro, Italia, 88100
- Novo Nordisk Investigational Site
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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
- Novo Nordisk Investigational Site
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Palermo, Italia, 90129
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Bialystok, Polonia, 15-435
- Novo Nordisk Investigational Site
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Skorzewo, Polonia, 60-185
- Novo Nordisk Investigational Site
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Warsaw, Polonia, 00-465
- Novo Nordisk Investigational Site
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Warsaw, Polonia, 02-793
- Novo Nordisk Investigational Site
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Warszawa, Polonia, 02-507
- Novo Nordisk Investigational Site
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Wroclaw, Polonia, 50-381
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Ponce, Porto Rico, 00716
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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
- Novo Nordisk Investigational Site
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Mures
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Tirgu Mures, Mures, Romania, 540142
- Novo Nordisk Investigational Site
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Timis
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Timisoara, Timis, Romania, 300125
- Novo Nordisk Investigational Site
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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, Slovacchia, 040 01
- Novo Nordisk Investigational Site
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Kysucke Nove Mesto, Slovacchia, 024 01
- Novo Nordisk Investigational Site
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Lubochna, Slovacchia, 03491
- Novo Nordisk Investigational Site
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Lucenec, Slovacchia, 984 01
- Novo Nordisk Investigational Site
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Zilina, Slovacchia, 01001
- Novo Nordisk Investigational Site
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Alcobendas, Spagna, 28100
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Almería, Spagna, 04001
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Girona, Spagna, 17007
- Novo Nordisk Investigational Site
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La Coruña, Spagna, 15006
- Novo Nordisk Investigational Site
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Pozuelo de Alarcon, Spagna, 28223
- Novo Nordisk Investigational Site
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Sabadell, Spagna, 08208
- Novo Nordisk Investigational Site
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Sevilla, Spagna, 41010
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Sevilla, Spagna, 41003
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California
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Concord, California, Stati Uniti, 94520
- Novo Nordisk Investigational Site
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Fresno, California, Stati Uniti, 93720
- Novo Nordisk Investigational Site
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Fullerton, California, Stati Uniti, 92835
- Novo Nordisk Investigational Site
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Lancaster, California, Stati Uniti, 93534
- Novo Nordisk Investigational Site
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Norco, California, Stati Uniti, 92860
- Novo Nordisk Investigational Site
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Sacramento, California, Stati Uniti, 95821
- Novo Nordisk Investigational Site
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Ventura, California, Stati Uniti, 93003
- Novo Nordisk Investigational Site
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Walnut Creek, California, Stati Uniti, 94598
- Novo Nordisk Investigational Site
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Colorado
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Denver, Colorado, Stati Uniti, 80246
- Novo Nordisk Investigational Site
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Golden, Colorado, Stati Uniti, 80401
- Novo Nordisk Investigational Site
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Connecticut
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Waterbury, Connecticut, Stati Uniti, 06708
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Florida
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Boynton Beach, Florida, Stati Uniti, 33472
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Bradenton, Florida, Stati Uniti, 34201
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Fort Lauderdale, Florida, Stati Uniti, 33312
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Miami, Florida, Stati Uniti, 33174
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Tampa, Florida, Stati Uniti, 33634
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Georgia
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Alpharetta, Georgia, Stati Uniti, 30022
- Novo Nordisk Investigational Site
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Lawrenceville, Georgia, Stati Uniti, 30046
- Novo Nordisk Investigational Site
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Roswell, Georgia, Stati Uniti, 30076
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96814
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
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Peoria, Illinois, Stati Uniti, 61603
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Springfield, Illinois, Stati Uniti, 62711
- Novo Nordisk Investigational Site
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Indiana
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Valparaiso, Indiana, Stati Uniti, 46383
- Novo Nordisk Investigational Site
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Iowa
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West Des Moines, Iowa, Stati Uniti, 50266
- Novo Nordisk Investigational Site
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Kansas
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Topeka, Kansas, Stati Uniti, 66606
- Novo Nordisk Investigational Site
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
- Novo Nordisk Investigational Site
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Lexington, Kentucky, Stati Uniti, 40502
- Novo Nordisk Investigational Site
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Maryland
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Rockville, Maryland, Stati Uniti, 20852
- Novo Nordisk Investigational Site
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Massachusetts
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Waltham, Massachusetts, Stati Uniti, 02453
- Novo Nordisk Investigational Site
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Worcester, Massachusetts, Stati Uniti, 01655
- Novo Nordisk Investigational Site
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Nevada
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Henderson, Nevada, Stati Uniti, 89052-2649
- Novo Nordisk Investigational Site
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Las Vegas, Nevada, Stati Uniti, 89148
- Novo Nordisk Investigational Site
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New Hampshire
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Nashua, New Hampshire, Stati Uniti, 03063
- Novo Nordisk Investigational Site
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New York
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Northport, New York, Stati Uniti, 11768
- Novo Nordisk Investigational Site
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West Seneca, New York, Stati Uniti, 14224
- Novo Nordisk Investigational Site
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28803
- Novo Nordisk Investigational Site
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Chapel Hill, North Carolina, Stati Uniti, 27514
- Novo Nordisk Investigational Site
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Ohio
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Mentor, Ohio, Stati Uniti, 44060
- Novo Nordisk Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104-5020
- Novo Nordisk Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19140
- Novo Nordisk Investigational Site
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29605-4254
- Novo Nordisk Investigational Site
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37404
- Novo Nordisk Investigational Site
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Chattanooga, Tennessee, Stati Uniti, 37411
- Novo Nordisk Investigational Site
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Nashville, Tennessee, Stati Uniti, 37212
- Novo Nordisk Investigational Site
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Texas
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Amarillo, Texas, Stati Uniti, 79106
- Novo Nordisk Investigational Site
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Austin, Texas, Stati Uniti, 78731
- Novo Nordisk Investigational Site
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Austin, Texas, Stati Uniti, 78749
- Novo Nordisk Investigational Site
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Beaumont, Texas, Stati Uniti, 77701
- Novo Nordisk Investigational Site
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Dallas, Texas, Stati Uniti, 75230
- Novo Nordisk Investigational Site
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Dallas, Texas, Stati Uniti, 75226
- Novo Nordisk Investigational Site
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Dallas, Texas, Stati Uniti, 75231
- Novo Nordisk Investigational Site
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Longview, Texas, Stati Uniti, 75605
- Novo Nordisk Investigational Site
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Pearland, Texas, Stati Uniti, 77584
- Novo Nordisk Investigational Site
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Round Rock, Texas, Stati Uniti, 78681
- Novo Nordisk Investigational Site
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Utah
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Ogden, Utah, Stati Uniti, 84405
- Novo Nordisk Investigational Site
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Vermont
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Bennington, Vermont, Stati Uniti, 05201
- Novo Nordisk Investigational Site
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South Burlington, Vermont, Stati Uniti, 05403
- Novo Nordisk Investigational Site
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Virginia
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Chesapeake, Virginia, Stati Uniti, 23321
- Novo Nordisk Investigational Site
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Winchester, Virginia, Stati Uniti, 22601-3834
- Novo Nordisk Investigational Site
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Washington
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Olympia, Washington, Stati Uniti, 98502
- Novo Nordisk Investigational Site
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Seattle, Washington, Stati Uniti, 98105
- Novo Nordisk Investigational Site
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Spokane, Washington, Stati Uniti, 99201
- Novo Nordisk Investigational Site
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Wisconsin
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Green Bay, Wisconsin, Stati Uniti, 54303
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Dnipro, Ucraina, 49038
- Novo Nordisk Investigational Site
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Kharkiv, Ucraina, 61000
- Novo Nordisk Investigational Site
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Kyiv, Ucraina, 03049
- Novo Nordisk Investigational Site
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Lviv, Ucraina, 79010
- Novo Nordisk Investigational Site
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Ternopil, Ucraina, 46002
- Novo Nordisk Investigational Site
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Vinnytsia, Ucraina, 21010
- Novo Nordisk Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Glycosylated Haemoglobin (HbA1c)
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in 1-hour PPG Increment
Lasso di tempo: Week 0, week 16
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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.
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Week 0, week 16
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Change From Baseline in 1,5-anhydroglucitol
Lasso di tempo: Week 0, week 16
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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.
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Week 0, week 16
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Change From Baseline in Fasting Plasma Glucose (FPG)
Lasso di tempo: Week 0, week 16
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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.
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Week 0, week 16
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Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
Lasso di tempo: 16 weeks after randomisation
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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.
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16 weeks after randomisation
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Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)
Lasso di tempo: 16 weeks after randomisation
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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])
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Week 0, week 16
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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.
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Week 0, week 16
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|
Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
19 settembre 2017
Completamento primario (Effettivo)
Completamento primario
7 gennaio 2019
Completamento dello studio (Effettivo)
Completamento dello studio
29 gennaio 2019
Date di iscrizione allo studio
Primo inviato
Primo inviato
29 agosto 2017
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
29 agosto 2017
Primo Inserito (Effettivo)
Primo Inserito
31 agosto 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
11 gennaio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 gennaio 2022
Ultimo verificato
Ultimo verificato
1 gennaio 2022
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema endocrino
- Diabete mellito
- Diabete mellito, tipo 2
- Agenti ipoglicemizzanti
- Effetti fisiologici delle droghe
- Insulina
- Insulina, Globina Zinco
- Insulina Aspart
- Insulina, ad azione prolungata
- Insulina degludec, combinazione di farmaci insulina aspart
- Metformina
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- NN1218-4113
- U1111-1180-0636 (Altro identificatore: World Health Organization (WHO))
- 2016-000878-38 (Identificatore di registro: European Medicines Agency (EudraCT))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Descrizione del piano IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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