- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03268005
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 stycznia 2022 zaktualizowane przez: 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).
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1264
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Caba, Argentyna, C1060ABA
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Caba, Argentyna, C1440AAD
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Cordoba, Argentyna, 5000
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Córdoba, Argentyna, 5008
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Kozloduy, Bułgaria, 3320
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Razgrad, Bułgaria, 7200
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Sofia, Bułgaria, 1233
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Sofia, Bułgaria, 1618
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Karlovac, Chorwacja, 47000
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Osijek, Chorwacja, 31 000
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Varazdin, Chorwacja, 42 000
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Zagreb, Chorwacja, 10 000
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Hradec Kralove, Czechy, 500 05
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Plzen, Czechy, 30100
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Plzen, Czechy, 32600
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Trutnov, Czechy, 541 01
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Arkhangelsk, Federacja Rosyjska, 163045
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Kazan, Federacja Rosyjska, 420073
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Moscow, Federacja Rosyjska, 123448
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Penza, Federacja Rosyjska, 440026
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Saint Petersburg, Federacja Rosyjska, 194291
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Saint-Petersburg, Federacja Rosyjska, 194356
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Tumen, Federacja Rosyjska, 625023
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Voronezh, Federacja Rosyjska, 394018
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Athens, Grecja, GR-11527
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Athens, Grecja, 115 25
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Ioannina, Grecja, 45500
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Larissa, Grecja, GR-41110
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Thessaloniki, Grecja, GR-54636
- Novo Nordisk Investigational Site
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Thessaloniki, Grecja, GR-57001
- Novo Nordisk Investigational Site
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Thessaloniki, Grecja, GR-54642
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Thessaloniki, Grecja, GR-54643
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Alcobendas, Hiszpania, 28100
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Almería, Hiszpania, 04001
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Girona, Hiszpania, 17007
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La Coruña, Hiszpania, 15006
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Pozuelo de Alarcon, Hiszpania, 28223
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Sabadell, Hiszpania, 08208
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Sevilla, Hiszpania, 41010
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Sevilla, Hiszpania, 41003
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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
- Novo Nordisk Investigational Site
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Newmarket, Ontario, Kanada, L3Y 5G8
- Novo Nordisk Investigational Site
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Thunder Bay, Ontario, Kanada, P7A 4V7
- Novo Nordisk Investigational Site
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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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Dresden, Niemcy, 01219
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Essen, Niemcy, 45136
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Falkensee, Niemcy, 14612
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Lingen, Niemcy, 49808
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Münster, Niemcy, 48145
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Saint Ingbert-Oberwürzbach, Niemcy, 66386
- Novo Nordisk Investigational Site
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Schweinfurt, Niemcy, 97421
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Bialystok, Polska, 15-435
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Skorzewo, Polska, 60-185
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Warsaw, Polska, 00-465
- Novo Nordisk Investigational Site
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Warsaw, Polska, 02-793
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Warszawa, Polska, 02-507
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Wroclaw, Polska, 50-381
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Ponce, Portoryko, 00716
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Bucheon, Republika Korei, 14647
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Daegu, Republika Korei, 42472
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Seongnam-si, Republika Korei, 463-707
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Seoul, Republika Korei, 02447
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Seoul, Republika Korei, 03080
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Seoul, Republika Korei, 04516
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Seoul, Republika Korei, 06351
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Seoul, Republika Korei, 08308
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Seoul, Republika Korei, 137-701
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Wonju, Republika Korei, 26426
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Brasov, Rumunia, 500101
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Brasov, Rumunia, 500283
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Bucharest, Rumunia, 13682
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Maramures
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Baia Mare, Maramures, Rumunia, 430222
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Mures
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Tirgu Mures, Mures, Rumunia, 540142
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Timis
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Timisoara, Timis, Rumunia, 300125
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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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California
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Concord, California, Stany Zjednoczone, 94520
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Fresno, California, Stany Zjednoczone, 93720
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Fullerton, California, Stany Zjednoczone, 92835
- Novo Nordisk Investigational Site
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Lancaster, California, Stany Zjednoczone, 93534
- Novo Nordisk Investigational Site
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Norco, California, Stany Zjednoczone, 92860
- Novo Nordisk Investigational Site
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Sacramento, California, Stany Zjednoczone, 95821
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Ventura, California, Stany Zjednoczone, 93003
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Walnut Creek, California, Stany Zjednoczone, 94598
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80246
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Golden, Colorado, Stany Zjednoczone, 80401
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Connecticut
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Waterbury, Connecticut, Stany Zjednoczone, 06708
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Florida
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Boynton Beach, Florida, Stany Zjednoczone, 33472
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Bradenton, Florida, Stany Zjednoczone, 34201
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Fort Lauderdale, Florida, Stany Zjednoczone, 33312
- Novo Nordisk Investigational Site
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Miami, Florida, Stany Zjednoczone, 33174
- Novo Nordisk Investigational Site
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Tampa, Florida, Stany Zjednoczone, 33634
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Georgia
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Alpharetta, Georgia, Stany Zjednoczone, 30022
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Lawrenceville, Georgia, Stany Zjednoczone, 30046
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Roswell, Georgia, Stany Zjednoczone, 30076
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96814
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60611
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Peoria, Illinois, Stany Zjednoczone, 61603
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Springfield, Illinois, Stany Zjednoczone, 62711
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Indiana
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Valparaiso, Indiana, Stany Zjednoczone, 46383
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Iowa
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West Des Moines, Iowa, Stany Zjednoczone, 50266
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Kansas
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Topeka, Kansas, Stany Zjednoczone, 66606
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Kentucky
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Lexington, Kentucky, Stany Zjednoczone, 40503
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Lexington, Kentucky, Stany Zjednoczone, 40502
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Maryland
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Rockville, Maryland, Stany Zjednoczone, 20852
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Massachusetts
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Waltham, Massachusetts, Stany Zjednoczone, 02453
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Worcester, Massachusetts, Stany Zjednoczone, 01655
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Nevada
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Henderson, Nevada, Stany Zjednoczone, 89052-2649
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Las Vegas, Nevada, Stany Zjednoczone, 89148
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New Hampshire
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Nashua, New Hampshire, Stany Zjednoczone, 03063
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New York
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Northport, New York, Stany Zjednoczone, 11768
- Novo Nordisk Investigational Site
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West Seneca, New York, Stany Zjednoczone, 14224
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North Carolina
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Asheville, North Carolina, Stany Zjednoczone, 28803
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Chapel Hill, North Carolina, Stany Zjednoczone, 27514
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Ohio
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Mentor, Ohio, Stany Zjednoczone, 44060
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73104-5020
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19140
- Novo Nordisk Investigational Site
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South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29605-4254
- Novo Nordisk Investigational Site
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Tennessee
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Chattanooga, Tennessee, Stany Zjednoczone, 37404
- Novo Nordisk Investigational Site
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Chattanooga, Tennessee, Stany Zjednoczone, 37411
- Novo Nordisk Investigational Site
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Nashville, Tennessee, Stany Zjednoczone, 37212
- Novo Nordisk Investigational Site
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Texas
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Amarillo, Texas, Stany Zjednoczone, 79106
- Novo Nordisk Investigational Site
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Austin, Texas, Stany Zjednoczone, 78731
- Novo Nordisk Investigational Site
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Austin, Texas, Stany Zjednoczone, 78749
- Novo Nordisk Investigational Site
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Beaumont, Texas, Stany Zjednoczone, 77701
- Novo Nordisk Investigational Site
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Dallas, Texas, Stany Zjednoczone, 75230
- Novo Nordisk Investigational Site
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Dallas, Texas, Stany Zjednoczone, 75226
- Novo Nordisk Investigational Site
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Dallas, Texas, Stany Zjednoczone, 75231
- Novo Nordisk Investigational Site
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Longview, Texas, Stany Zjednoczone, 75605
- Novo Nordisk Investigational Site
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Pearland, Texas, Stany Zjednoczone, 77584
- Novo Nordisk Investigational Site
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Round Rock, Texas, Stany Zjednoczone, 78681
- Novo Nordisk Investigational Site
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Utah
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Ogden, Utah, Stany Zjednoczone, 84405
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Vermont
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Bennington, Vermont, Stany Zjednoczone, 05201
- Novo Nordisk Investigational Site
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South Burlington, Vermont, Stany Zjednoczone, 05403
- Novo Nordisk Investigational Site
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Virginia
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Chesapeake, Virginia, Stany Zjednoczone, 23321
- Novo Nordisk Investigational Site
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Winchester, Virginia, Stany Zjednoczone, 22601-3834
- Novo Nordisk Investigational Site
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Washington
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Olympia, Washington, Stany Zjednoczone, 98502
- Novo Nordisk Investigational Site
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Seattle, Washington, Stany Zjednoczone, 98105
- Novo Nordisk Investigational Site
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Spokane, Washington, Stany Zjednoczone, 99201
- Novo Nordisk Investigational Site
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Wisconsin
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Green Bay, Wisconsin, Stany Zjednoczone, 54303
- Novo Nordisk Investigational Site
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Kosice, Słowacja, 040 01
- Novo Nordisk Investigational Site
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Kysucke Nove Mesto, Słowacja, 024 01
- Novo Nordisk Investigational Site
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Lubochna, Słowacja, 03491
- Novo Nordisk Investigational Site
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Lucenec, Słowacja, 984 01
- Novo Nordisk Investigational Site
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Zilina, Słowacja, 01001
- Novo Nordisk Investigational Site
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Dnipro, Ukraina, 49038
- Novo Nordisk Investigational Site
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Kharkiv, Ukraina, 61000
- Novo Nordisk Investigational Site
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Kyiv, Ukraina, 03049
- Novo Nordisk Investigational Site
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Lviv, Ukraina, 79010
- Novo Nordisk Investigational Site
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Ternopil, Ukraina, 46002
- Novo Nordisk Investigational Site
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Vinnytsia, Ukraina, 21010
- Novo Nordisk Investigational Site
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Catanzaro, Włochy, 88100
- Novo Nordisk Investigational Site
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Chieti, Włochy, 66100
- Novo Nordisk Investigational Site
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Cittadella (PD), Włochy, 35013
- Novo Nordisk Investigational Site
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Milano (MI), Włochy, 20132
- Novo Nordisk Investigational Site
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Olbia, Włochy, 07026
- Novo Nordisk Investigational Site
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Palermo, Włochy, 90129
- Novo Nordisk Investigational Site
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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).
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Glycosylated Haemoglobin (HbA1c)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change From Baseline in 1-hour PPG Increment
Ramy czasowe: 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
Ramy czasowe: 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.
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Week 0, week 16
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Change From Baseline in Fasting Plasma Glucose (FPG)
Ramy czasowe: 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.
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Week 0, week 16
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Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
Ramy czasowe: 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.
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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)
Ramy czasowe: 16 weeks after randomisation
|
Number of participants reaching HbA1c <7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
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16 weeks after randomisation
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Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
19 września 2017
Zakończenie podstawowe (Rzeczywisty)
7 stycznia 2019
Ukończenie studiów (Rzeczywisty)
29 stycznia 2019
Daty rejestracji na studia
Pierwszy przesłany
29 sierpnia 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 sierpnia 2017
Pierwszy wysłany (Rzeczywisty)
31 sierpnia 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 stycznia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 stycznia 2022
Ostatnia weryfikacja
1 stycznia 2022
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NN1218-4113
- U1111-1180-0636 (Inny identyfikator: World Health Organization (WHO))
- 2016-000878-38 (Identyfikator rejestru: European Medicines Agency (EudraCT))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAk
Opis planu IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Cukrzyca typu 2
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Leiden University Medical CenterZakończonyGruczolak przysadki | Guz przysadki | Diabetes Insipidus Cranial Type | Dokrewny; NiedobórHolandia
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Centre Hospitalier Universitaire de LiegeSanofi; Takeda; University of Liege; Orchard Therapeutics; Centre Hospitalier Régional... i inni współpracownicyRekrutacyjnyWrodzony przerost nadnerczy | Hemofilia A | Hemofilia B | Mukopolisacharydoza I | Mukopolisacharydoza II | Mukowiscydoza | Niedobór alfa 1-antytrypsyny | Anemia sierpowata | Anemia Fanconiego | Przewlekła choroba ziarniniakowa | Choroba Wilsona | Ciężka wrodzona neutropenia | Niedobór transkarbamylazy ornityny | Mukopolisacharydoza... i inne warunkiBelgia
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UK Kidney AssociationRekrutacyjnyZapalenie naczyń | AL Amyloidoza | Stwardnienie guzowate | Choroba Fabry'ego | Cystynuria | Ogniskowe segmentowe stwardnienie kłębuszków nerkowych | Nefropatia IgA | Syndrom Barttera | Czysta aplazja czerwonokrwinkowa | Nefropatia błoniasta | Atypowy zespół hemolityczno-mocznicowy | Autosomalna dominująca policystyczna... i inne warunkiZjednoczone Królestwo
Badania kliniczne na Faster-acting insulin aspart
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Michigan State UniversityZakończonyĆwiczenie | InsulinaStany Zjednoczone