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)
2022年1月6日 更新者：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).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
1264
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Dnipro、乌克兰、49038
- Novo Nordisk Investigational Site
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Kharkiv、乌克兰、61000
- Novo Nordisk Investigational Site
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Kyiv、乌克兰、03049
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Lviv、乌克兰、79010
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Ternopil、乌克兰、46002
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Vinnytsia、乌克兰、21010
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Arkhangelsk、俄罗斯联邦、163045
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Kazan、俄罗斯联邦、420073
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Moscow、俄罗斯联邦、123448
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Penza、俄罗斯联邦、440026
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Saint Petersburg、俄罗斯联邦、194291
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Saint-Petersburg、俄罗斯联邦、194356
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Tumen、俄罗斯联邦、625023
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Voronezh、俄罗斯联邦、394018
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Kozloduy、保加利亚、3320
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Razgrad、保加利亚、7200
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Sofia、保加利亚、1233
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Sofia、保加利亚、1618
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Karlovac、克罗地亚、47000
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Osijek、克罗地亚、31 000
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Varazdin、克罗地亚、42 000
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Zagreb、克罗地亚、10 000
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Alberta
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Edmonton、Alberta、加拿大、T6G 2E1
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British Columbia
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Victoria、British Columbia、加拿大、V8V 4A1
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3H 2Y9
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Ontario
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Barrie、Ontario、加拿大、L4N 7L3
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Concord、Ontario、加拿大、L4K 4M2
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Etobicoke、Ontario、加拿大、M9R 4E1
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Hamilton、Ontario、加拿大、L8M 1K7
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Newmarket、Ontario、加拿大、L3Y 5G8
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Thunder Bay、Ontario、加拿大、P7A 4V7
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Toronto、Ontario、加拿大、M4G 3E8
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Quebec
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Montreal、Quebec、加拿大、H4T 1Z9
- Novo Nordisk Investigational Site
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Belgrade、塞尔维亚、11000
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Kragujevac、塞尔维亚、34000
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Nis、塞尔维亚、18000
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Novi Sad、塞尔维亚、21000
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Zajecar、塞尔维亚、19000
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Bucheon、大韩民国、14647
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Daegu、大韩民国、42472
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Seongnam-si、大韩民国、463-707
- Novo Nordisk Investigational Site
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Seoul、大韩民国、02447
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Seoul、大韩民国、03080
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Seoul、大韩民国、04516
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Seoul、大韩民国、06351
- Novo Nordisk Investigational Site
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Seoul、大韩民国、08308
- Novo Nordisk Investigational Site
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Seoul、大韩民国、137-701
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Wonju、大韩民国、26426
- Novo Nordisk Investigational Site
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Athens、希腊、GR-11527
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Athens、希腊、115 25
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Ioannina、希腊、45500
- Novo Nordisk Investigational Site
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Larissa、希腊、GR-41110
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Thessaloniki、希腊、GR-54636
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Thessaloniki、希腊、GR-57001
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Thessaloniki、希腊、GR-54642
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Thessaloniki、希腊、GR-54643
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Dresden、德国、01219
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Essen、德国、45136
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Falkensee、德国、14612
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Lingen、德国、49808
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Münster、德国、48145
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Saint Ingbert-Oberwürzbach、德国、66386
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Schweinfurt、德国、97421
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Catanzaro、意大利、88100
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Chieti、意大利、66100
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Cittadella (PD)、意大利、35013
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Milano (MI)、意大利、20132
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Olbia、意大利、07026
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Palermo、意大利、90129
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Hradec Kralove、捷克语、500 05
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Plzen、捷克语、30100
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Plzen、捷克语、32600
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Trutnov、捷克语、541 01
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Kosice、斯洛伐克、040 01
- Novo Nordisk Investigational Site
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Kysucke Nove Mesto、斯洛伐克、024 01
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Lubochna、斯洛伐克、03491
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Lucenec、斯洛伐克、984 01
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Zilina、斯洛伐克、01001
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Bialystok、波兰、15-435
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Skorzewo、波兰、60-185
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Warsaw、波兰、00-465
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Warsaw、波兰、02-793
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Warszawa、波兰、02-507
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Wroclaw、波兰、50-381
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Ponce、波多黎各、00716
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Brasov、罗马尼亚、500101
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Brasov、罗马尼亚、500283
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Bucharest、罗马尼亚、13682
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Maramures
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Baia Mare、Maramures、罗马尼亚、430222
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Mures
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Tirgu Mures、Mures、罗马尼亚、540142
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Timis
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Timisoara、Timis、罗马尼亚、300125
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California
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Concord、California、美国、94520
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Fresno、California、美国、93720
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Fullerton、California、美国、92835
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Lancaster、California、美国、93534
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Norco、California、美国、92860
- Novo Nordisk Investigational Site
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Sacramento、California、美国、95821
- Novo Nordisk Investigational Site
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Ventura、California、美国、93003
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Walnut Creek、California、美国、94598
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Colorado
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Denver、Colorado、美国、80246
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Golden、Colorado、美国、80401
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Connecticut
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Waterbury、Connecticut、美国、06708
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Florida
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Boynton Beach、Florida、美国、33472
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Bradenton、Florida、美国、34201
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Fort Lauderdale、Florida、美国、33312
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Miami、Florida、美国、33174
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Tampa、Florida、美国、33634
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Georgia
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Alpharetta、Georgia、美国、30022
- Novo Nordisk Investigational Site
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Lawrenceville、Georgia、美国、30046
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Roswell、Georgia、美国、30076
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Hawaii
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Honolulu、Hawaii、美国、96814
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Illinois
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Chicago、Illinois、美国、60611
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Peoria、Illinois、美国、61603
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Springfield、Illinois、美国、62711
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Indiana
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Valparaiso、Indiana、美国、46383
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Iowa
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West Des Moines、Iowa、美国、50266
- Novo Nordisk Investigational Site
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Kansas
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Topeka、Kansas、美国、66606
- Novo Nordisk Investigational Site
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Kentucky
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Lexington、Kentucky、美国、40503
- Novo Nordisk Investigational Site
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Lexington、Kentucky、美国、40502
- Novo Nordisk Investigational Site
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Maryland
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Rockville、Maryland、美国、20852
- Novo Nordisk Investigational Site
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Massachusetts
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Waltham、Massachusetts、美国、02453
- Novo Nordisk Investigational Site
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Worcester、Massachusetts、美国、01655
- Novo Nordisk Investigational Site
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Nevada
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Henderson、Nevada、美国、89052-2649
- Novo Nordisk Investigational Site
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Las Vegas、Nevada、美国、89148
- Novo Nordisk Investigational Site
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New Hampshire
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Nashua、New Hampshire、美国、03063
- Novo Nordisk Investigational Site
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New York
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Northport、New York、美国、11768
- Novo Nordisk Investigational Site
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West Seneca、New York、美国、14224
- Novo Nordisk Investigational Site
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North Carolina
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Asheville、North Carolina、美国、28803
- Novo Nordisk Investigational Site
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Chapel Hill、North Carolina、美国、27514
- Novo Nordisk Investigational Site
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Ohio
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Mentor、Ohio、美国、44060
- Novo Nordisk Investigational Site
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104-5020
- Novo Nordisk Investigational Site
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19140
- Novo Nordisk Investigational Site
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South Carolina
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Greenville、South Carolina、美国、29605-4254
- Novo Nordisk Investigational Site
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Tennessee
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Chattanooga、Tennessee、美国、37404
- Novo Nordisk Investigational Site
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Chattanooga、Tennessee、美国、37411
- Novo Nordisk Investigational Site
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Nashville、Tennessee、美国、37212
- Novo Nordisk Investigational Site
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Texas
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Amarillo、Texas、美国、79106
- Novo Nordisk Investigational Site
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Austin、Texas、美国、78731
- Novo Nordisk Investigational Site
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Austin、Texas、美国、78749
- Novo Nordisk Investigational Site
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Beaumont、Texas、美国、77701
- Novo Nordisk Investigational Site
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Dallas、Texas、美国、75230
- Novo Nordisk Investigational Site
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Dallas、Texas、美国、75226
- Novo Nordisk Investigational Site
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Dallas、Texas、美国、75231
- Novo Nordisk Investigational Site
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Longview、Texas、美国、75605
- Novo Nordisk Investigational Site
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Pearland、Texas、美国、77584
- Novo Nordisk Investigational Site
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Round Rock、Texas、美国、78681
- Novo Nordisk Investigational Site
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Utah
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Ogden、Utah、美国、84405
- Novo Nordisk Investigational Site
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Vermont
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Bennington、Vermont、美国、05201
- Novo Nordisk Investigational Site
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South Burlington、Vermont、美国、05403
- Novo Nordisk Investigational Site
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Virginia
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Chesapeake、Virginia、美国、23321
- Novo Nordisk Investigational Site
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Winchester、Virginia、美国、22601-3834
- Novo Nordisk Investigational Site
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Washington
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Olympia、Washington、美国、98502
- Novo Nordisk Investigational Site
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Seattle、Washington、美国、98105
- Novo Nordisk Investigational Site
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Spokane、Washington、美国、99201
- Novo Nordisk Investigational Site
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Wisconsin
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Green Bay、Wisconsin、美国、54303
- Novo Nordisk Investigational Site
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Alcobendas、西班牙、28100
- Novo Nordisk Investigational Site
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Almería、西班牙、04001
- Novo Nordisk Investigational Site
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Girona、西班牙、17007
- Novo Nordisk Investigational Site
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La Coruña、西班牙、15006
- Novo Nordisk Investigational Site
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Pozuelo de Alarcon、西班牙、28223
- Novo Nordisk Investigational Site
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Sabadell、西班牙、08208
- Novo Nordisk Investigational Site
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Sevilla、西班牙、41010
- Novo Nordisk Investigational Site
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Sevilla、西班牙、41003
- Novo Nordisk Investigational Site
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Caba、阿根廷、C1060ABA
- Novo Nordisk Investigational Site
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Caba、阿根廷、C1440AAD
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Cordoba、阿根廷、5000
- Novo Nordisk Investigational Site
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Córdoba、阿根廷、5008
- Novo Nordisk Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Faster aspart + insulin degludec with or without metformin
|
Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks.
Dose individually adjusted.
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks.
Dose individually adjusted.
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
|
|
有源比较器：NovoRapid/NovoLog + insulin degludec with or without metformin
|
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks.
Dose individually adjusted.
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks.
Dose individually adjusted.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
大体时间：Week 0, week 16
|
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16.
The endpoint was evaluated based on data from the in-trial observation period.
In-trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in 1-hour PPG Increment
大体时间：Week 0, week 16
|
Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
|
Change From Baseline in 1,5-anhydroglucitol
大体时间：Week 0, week 16
|
Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
大体时间：Week 0, week 16
|
Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
Week 0, week 16
|
|
Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
大体时间：16 weeks after randomisation
|
Number of participants reaching HbA1c <7.0% (53 mmol/L) was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
16 weeks after randomisation
|
|
Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)
大体时间：16 weeks after randomisation
|
Number of participants reaching HbA1c <7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
|
16 weeks after randomisation
|
|
Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])
大体时间：Week 0, week 16
|
Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test.
The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
|
Week 0, week 16
|
|
Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
大体时间：Week 0, week 16
|
Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation.
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test.
The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.
|
Week 0, week 16
|
|
Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月19日
初级完成 (实际的)
2019年1月7日
研究完成 (实际的)
2019年1月29日
研究注册日期
首次提交
2017年8月29日
首先提交符合 QC 标准的
2017年8月29日
首次发布 (实际的)
2017年8月31日
研究记录更新
最后更新发布 (实际的)
2022年1月11日
上次提交的符合 QC 标准的更新
2022年1月6日
最后验证
2022年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NN1218-4113
- U1111-1180-0636 (其他标识符：World Health Organization (WHO))
- 2016-000878-38 (注册表标识符：European Medicines Agency (EudraCT))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.