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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. januar 2022 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1264

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Argentina
- - Caba, Argentina, C1060ABA
    - Novo Nordisk Investigational Site
  - Caba, Argentina, C1440AAD
    - Novo Nordisk Investigational Site
  - Cordoba, Argentina, 5000
    - Novo Nordisk Investigational Site
  - Córdoba, Argentina, 5008
    - Novo Nordisk Investigational Site
Bulgarien
- - Kozloduy, Bulgarien, 3320
    - Novo Nordisk Investigational Site
  - Razgrad, Bulgarien, 7200
    - Novo Nordisk Investigational Site
  - Sofia, Bulgarien, 1233
    - Novo Nordisk Investigational Site
  - Sofia, Bulgarien, 1618
    - Novo Nordisk Investigational Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2E1
    - Novo Nordisk Investigational Site
- British Columbia
  - Victoria, British Columbia, Canada, V8V 4A1
    - Novo Nordisk Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Novo Nordisk Investigational Site
- Ontario
  - Barrie, Ontario, Canada, L4N 7L3
    - Novo Nordisk Investigational Site
  - Concord, Ontario, Canada, L4K 4M2
    - Novo Nordisk Investigational Site
  - Etobicoke, Ontario, Canada, M9R 4E1
    - Novo Nordisk Investigational Site
  - Hamilton, Ontario, Canada, L8M 1K7
    - Novo Nordisk Investigational Site
  - Newmarket, Ontario, Canada, L3Y 5G8
    - Novo Nordisk Investigational Site
  - Thunder Bay, Ontario, Canada, P7A 4V7
    - Novo Nordisk Investigational Site
  - Toronto, Ontario, Canada, M4G 3E8
    - Novo Nordisk Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H4T 1Z9
    - Novo Nordisk Investigational Site
Den Russiske Føderation
- - Arkhangelsk, Den Russiske Føderation, 163045
    - Novo Nordisk Investigational Site
  - Kazan, Den Russiske Føderation, 420073
    - Novo Nordisk Investigational Site
  - Moscow, Den Russiske Føderation, 123448
    - Novo Nordisk Investigational Site
  - Penza, Den Russiske Føderation, 440026
    - Novo Nordisk Investigational Site
  - Saint Petersburg, Den Russiske Føderation, 194291
    - Novo Nordisk Investigational Site
  - Saint-Petersburg, Den Russiske Føderation, 194356
    - Novo Nordisk Investigational Site
  - Tumen, Den Russiske Føderation, 625023
    - Novo Nordisk Investigational Site
  - Voronezh, Den Russiske Føderation, 394018
    - Novo Nordisk Investigational Site
Forenede Stater
- California
  - Concord, California, Forenede Stater, 94520
    - Novo Nordisk Investigational Site
  - Fresno, California, Forenede Stater, 93720
    - Novo Nordisk Investigational Site
  - Fullerton, California, Forenede Stater, 92835
    - Novo Nordisk Investigational Site
  - Lancaster, California, Forenede Stater, 93534
    - Novo Nordisk Investigational Site
  - Norco, California, Forenede Stater, 92860
    - Novo Nordisk Investigational Site
  - Sacramento, California, Forenede Stater, 95821
    - Novo Nordisk Investigational Site
  - Ventura, California, Forenede Stater, 93003
    - Novo Nordisk Investigational Site
  - Walnut Creek, California, Forenede Stater, 94598
    - Novo Nordisk Investigational Site
- Colorado
  - Denver, Colorado, Forenede Stater, 80246
    - Novo Nordisk Investigational Site
  - Golden, Colorado, Forenede Stater, 80401
    - Novo Nordisk Investigational Site
- Connecticut
  - Waterbury, Connecticut, Forenede Stater, 06708
    - Novo Nordisk Investigational Site
- Florida
  - Boynton Beach, Florida, Forenede Stater, 33472
    - Novo Nordisk Investigational Site
  - Bradenton, Florida, Forenede Stater, 34201
    - Novo Nordisk Investigational Site
  - Fort Lauderdale, Florida, Forenede Stater, 33312
    - Novo Nordisk Investigational Site
  - Miami, Florida, Forenede Stater, 33174
    - Novo Nordisk Investigational Site
  - Tampa, Florida, Forenede Stater, 33634
    - Novo Nordisk Investigational Site
- Georgia
  - Alpharetta, Georgia, Forenede Stater, 30022
    - Novo Nordisk Investigational Site
  - Lawrenceville, Georgia, Forenede Stater, 30046
    - Novo Nordisk Investigational Site
  - Roswell, Georgia, Forenede Stater, 30076
    - Novo Nordisk Investigational Site
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96814
    - Novo Nordisk Investigational Site
- Illinois
  - Chicago, Illinois, Forenede Stater, 60611
    - Novo Nordisk Investigational Site
  - Peoria, Illinois, Forenede Stater, 61603
    - Novo Nordisk Investigational Site
  - Springfield, Illinois, Forenede Stater, 62711
    - Novo Nordisk Investigational Site
- Indiana
  - Valparaiso, Indiana, Forenede Stater, 46383
    - Novo Nordisk Investigational Site
- Iowa
  - West Des Moines, Iowa, Forenede Stater, 50266
    - Novo Nordisk Investigational Site
- Kansas
  - Topeka, Kansas, Forenede Stater, 66606
    - Novo Nordisk Investigational Site
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40503
    - Novo Nordisk Investigational Site
  - Lexington, Kentucky, Forenede Stater, 40502
    - Novo Nordisk Investigational Site
- Maryland
  - Rockville, Maryland, Forenede Stater, 20852
    - Novo Nordisk Investigational Site
- Massachusetts
  - Waltham, Massachusetts, Forenede Stater, 02453
    - Novo Nordisk Investigational Site
  - Worcester, Massachusetts, Forenede Stater, 01655
    - Novo Nordisk Investigational Site
- Nevada
  - Henderson, Nevada, Forenede Stater, 89052-2649
    - Novo Nordisk Investigational Site
  - Las Vegas, Nevada, Forenede Stater, 89148
    - Novo Nordisk Investigational Site
- New Hampshire
  - Nashua, New Hampshire, Forenede Stater, 03063
    - Novo Nordisk Investigational Site
- New York
  - Northport, New York, Forenede Stater, 11768
    - Novo Nordisk Investigational Site
  - West Seneca, New York, Forenede Stater, 14224
    - Novo Nordisk Investigational Site
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28803
    - Novo Nordisk Investigational Site
  - Chapel Hill, North Carolina, Forenede Stater, 27514
    - Novo Nordisk Investigational Site
- Ohio
  - Mentor, Ohio, Forenede Stater, 44060
    - Novo Nordisk Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104-5020
    - Novo Nordisk Investigational Site
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19140
    - Novo Nordisk Investigational Site
- South Carolina
  - Greenville, South Carolina, Forenede Stater, 29605-4254
    - Novo Nordisk Investigational Site
- Tennessee
  - Chattanooga, Tennessee, Forenede Stater, 37404
    - Novo Nordisk Investigational Site
  - Chattanooga, Tennessee, Forenede Stater, 37411
    - Novo Nordisk Investigational Site
  - Nashville, Tennessee, Forenede Stater, 37212
    - Novo Nordisk Investigational Site
- Texas
  - Amarillo, Texas, Forenede Stater, 79106
    - Novo Nordisk Investigational Site
  - Austin, Texas, Forenede Stater, 78731
    - Novo Nordisk Investigational Site
  - Austin, Texas, Forenede Stater, 78749
    - Novo Nordisk Investigational Site
  - Beaumont, Texas, Forenede Stater, 77701
    - Novo Nordisk Investigational Site
  - Dallas, Texas, Forenede Stater, 75230
    - Novo Nordisk Investigational Site
  - Dallas, Texas, Forenede Stater, 75226
    - Novo Nordisk Investigational Site
  - Dallas, Texas, Forenede Stater, 75231
    - Novo Nordisk Investigational Site
  - Longview, Texas, Forenede Stater, 75605
    - Novo Nordisk Investigational Site
  - Pearland, Texas, Forenede Stater, 77584
    - Novo Nordisk Investigational Site
  - Round Rock, Texas, Forenede Stater, 78681
    - Novo Nordisk Investigational Site
- Utah
  - Ogden, Utah, Forenede Stater, 84405
    - Novo Nordisk Investigational Site
- Vermont
  - Bennington, Vermont, Forenede Stater, 05201
    - Novo Nordisk Investigational Site
  - South Burlington, Vermont, Forenede Stater, 05403
    - Novo Nordisk Investigational Site
- Virginia
  - Chesapeake, Virginia, Forenede Stater, 23321
    - Novo Nordisk Investigational Site
  - Winchester, Virginia, Forenede Stater, 22601-3834
    - Novo Nordisk Investigational Site
- Washington
  - Olympia, Washington, Forenede Stater, 98502
    - Novo Nordisk Investigational Site
  - Seattle, Washington, Forenede Stater, 98105
    - Novo Nordisk Investigational Site
  - Spokane, Washington, Forenede Stater, 99201
    - Novo Nordisk Investigational Site
- Wisconsin
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - Novo Nordisk Investigational Site
Grækenland
- - Athens, Grækenland, GR-11527
    - Novo Nordisk Investigational Site
  - Athens, Grækenland, 115 25
    - Novo Nordisk Investigational Site
  - Ioannina, Grækenland, 45500
    - Novo Nordisk Investigational Site
  - Larissa, Grækenland, GR-41110
    - Novo Nordisk Investigational Site
  - Thessaloniki, Grækenland, GR-54636
    - Novo Nordisk Investigational Site
  - Thessaloniki, Grækenland, GR-57001
    - Novo Nordisk Investigational Site
  - Thessaloniki, Grækenland, GR-54642
    - Novo Nordisk Investigational Site
  - Thessaloniki, Grækenland, GR-54643
    - Novo Nordisk Investigational Site
Italien
- - Catanzaro, Italien, 88100
    - Novo Nordisk Investigational Site
  - Chieti, Italien, 66100
    - Novo Nordisk Investigational Site
  - Cittadella (PD), Italien, 35013
    - Novo Nordisk Investigational Site
  - Milano (MI), Italien, 20132
    - Novo Nordisk Investigational Site
  - Olbia, Italien, 07026
    - Novo Nordisk Investigational Site
  - Palermo, Italien, 90129
    - Novo Nordisk Investigational Site
Korea, Republikken
- - Bucheon, Korea, Republikken, 14647
    - Novo Nordisk Investigational Site
  - Daegu, Korea, Republikken, 42472
    - Novo Nordisk Investigational Site
  - Seongnam-si, Korea, Republikken, 463-707
    - Novo Nordisk Investigational Site
  - Seoul, Korea, Republikken, 02447
    - Novo Nordisk Investigational Site
  - Seoul, Korea, Republikken, 03080
    - Novo Nordisk Investigational Site
  - Seoul, Korea, Republikken, 04516
    - Novo Nordisk Investigational Site
  - Seoul, Korea, Republikken, 06351
    - Novo Nordisk Investigational Site
  - Seoul, Korea, Republikken, 08308
    - Novo Nordisk Investigational Site
  - Seoul, Korea, Republikken, 137-701
    - Novo Nordisk Investigational Site
  - Wonju, Korea, Republikken, 26426
    - Novo Nordisk Investigational Site
Kroatien
- - Karlovac, Kroatien, 47000
    - Novo Nordisk Investigational Site
  - Osijek, Kroatien, 31 000
    - Novo Nordisk Investigational Site
  - Varazdin, Kroatien, 42 000
    - Novo Nordisk Investigational Site
  - Zagreb, Kroatien, 10 000
    - Novo Nordisk Investigational Site
Polen
- - Bialystok, Polen, 15-435
    - Novo Nordisk Investigational Site
  - Skorzewo, Polen, 60-185
    - Novo Nordisk Investigational Site
  - Warsaw, Polen, 00-465
    - Novo Nordisk Investigational Site
  - Warsaw, Polen, 02-793
    - Novo Nordisk Investigational Site
  - Warszawa, Polen, 02-507
    - Novo Nordisk Investigational Site
  - Wroclaw, Polen, 50-381
    - Novo Nordisk Investigational Site
Puerto Rico
- - Ponce, Puerto Rico, 00716
    - Novo Nordisk Investigational Site
Rumænien
- - Brasov, Rumænien, 500101
    - Novo Nordisk Investigational Site
  - Brasov, Rumænien, 500283
    - Novo Nordisk Investigational Site
  - Bucharest, Rumænien, 13682
    - Novo Nordisk Investigational Site
- Maramures
  - Baia Mare, Maramures, Rumænien, 430222
    - Novo Nordisk Investigational Site
- Mures
  - Tirgu Mures, Mures, Rumænien, 540142
    - Novo Nordisk Investigational Site
- Timis
  - Timisoara, Timis, Rumænien, 300125
    - Novo Nordisk Investigational Site
Serbien
- - Belgrade, Serbien, 11000
    - Novo Nordisk Investigational Site
  - Kragujevac, Serbien, 34000
    - Novo Nordisk Investigational Site
  - Nis, Serbien, 18000
    - Novo Nordisk Investigational Site
  - Novi Sad, Serbien, 21000
    - Novo Nordisk Investigational Site
  - Zajecar, Serbien, 19000
    - Novo Nordisk Investigational Site
Slovakiet
- - Kosice, Slovakiet, 040 01
    - Novo Nordisk Investigational Site
  - Kysucke Nove Mesto, Slovakiet, 024 01
    - Novo Nordisk Investigational Site
  - Lubochna, Slovakiet, 03491
    - Novo Nordisk Investigational Site
  - Lucenec, Slovakiet, 984 01
    - Novo Nordisk Investigational Site
  - Zilina, Slovakiet, 01001
    - Novo Nordisk Investigational Site
Spanien
- - Alcobendas, Spanien, 28100
    - Novo Nordisk Investigational Site
  - Almería, Spanien, 04001
    - Novo Nordisk Investigational Site
  - Girona, Spanien, 17007
    - Novo Nordisk Investigational Site
  - La Coruña, Spanien, 15006
    - Novo Nordisk Investigational Site
  - Pozuelo de Alarcon, Spanien, 28223
    - Novo Nordisk Investigational Site
  - Sabadell, Spanien, 08208
    - Novo Nordisk Investigational Site
  - Sevilla, Spanien, 41010
    - Novo Nordisk Investigational Site
  - Sevilla, Spanien, 41003
    - Novo Nordisk Investigational Site
Tjekkiet
- - Hradec Kralove, Tjekkiet, 500 05
    - Novo Nordisk Investigational Site
  - Plzen, Tjekkiet, 30100
    - Novo Nordisk Investigational Site
  - Plzen, Tjekkiet, 32600
    - Novo Nordisk Investigational Site
  - Trutnov, Tjekkiet, 541 01
    - Novo Nordisk Investigational Site
Tyskland
- - Dresden, Tyskland, 01219
    - Novo Nordisk Investigational Site
  - Essen, Tyskland, 45136
    - Novo Nordisk Investigational Site
  - Falkensee, Tyskland, 14612
    - Novo Nordisk Investigational Site
  - Lingen, Tyskland, 49808
    - Novo Nordisk Investigational Site
  - Münster, Tyskland, 48145
    - Novo Nordisk Investigational Site
  - Saint Ingbert-Oberwürzbach, Tyskland, 66386
    - Novo Nordisk Investigational Site
  - Schweinfurt, Tyskland, 97421
    - Novo Nordisk Investigational Site
Ukraine
- - Dnipro, Ukraine, 49038
    - Novo Nordisk Investigational Site
  - Kharkiv, Ukraine, 61000
    - Novo Nordisk Investigational Site
  - Kyiv, Ukraine, 03049
    - Novo Nordisk Investigational Site
  - Lviv, Ukraine, 79010
    - Novo Nordisk Investigational Site
  - Ternopil, Ukraine, 46002
    - Novo Nordisk Investigational Site
  - Vinnytsia, Ukraine, 21010
    - Novo Nordisk Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Faster aspart + insulin degludec with or without metformin	Medicin: Faster-acting insulin aspart Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Medicin: Insulin degludec Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Medicin: Metformin Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Aktiv komparator: NovoRapid/NovoLog + insulin degludec with or without metformin	Medicin: Insulin degludec Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Medicin: Metformin Only participants who took metformin before the study should take metformin tablets, same dose as before the study Medicin: Insulin aspart Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: Faster aspart + insulin degludec with or without metformin

Medicin: Faster-acting insulin aspart

Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Medicin: Insulin degludec

Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Medicin: Metformin

Only participants who took metformin before the study should take metformin tablets, same dose as before the study

Aktiv komparator: NovoRapid/NovoLog + insulin degludec with or without metformin

Medicin: Insulin degludec

Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Medicin: Metformin

Only participants who took metformin before the study should take metformin tablets, same dose as before the study

Medicin: Insulin aspart

Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change in Glycosylated Haemoglobin (HbA1c) Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change From Baseline in 1-hour PPG Increment Tidsramme: 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 Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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]) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: Weeks 0-16	ADA classification of hypos: Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. Documented symptomatic: PG ≤3.9 mmol/L with symptoms. Asymptomatic: PG ≤3.9 mmol/L without symptoms. Probable symptomatic: No measurement with symptoms. Pseudo: PG >3.9 mmol/L with symptoms. Unclassifiable. NN classification of hypos: BG confirmed: PG <3.1 mmol/L with/without symptoms. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia.	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) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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 Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. september 2017

Primær færdiggørelse (Faktiske)

7. januar 2019

Studieafslutning (Faktiske)

29. januar 2019

Datoer for studieregistrering

Først indsendt

29. august 2017

Først indsendt, der opfyldte QC-kriterier

29. august 2017

Først opslået (Faktiske)

31. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NN1218-4113
U1111-1180-0636 (Anden identifikator: World Health Organization (WHO))
2016-000878-38 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Et 26-ugers forsøg, der sammenligner effektivitet og sikkerhed af Insulin Degludec/Insulin Aspart BID og Insulin Degludec OD Plus Insulin Aspart hos forsøgspersoner med type 2 diabetes mellitus behandlet med basal insulin i behov for behandling Intensivering med måltidsinsulin

Diabetes mellitus, type 2 | Diabetes

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)

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)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med Faster-acting insulin aspart

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer