Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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 de enero de 2022 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

1264

Fase

Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo Grupo de participantes/brazo Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.	Intervención / Tratamiento Intervención / Tratamiento Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Experimental: Faster aspart + insulin degludec with or without metformin	Droga: Faster-acting insulin aspart Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Droga: Insulin degludec Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Droga: Metformin Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Comparador activo: NovoRapid/NovoLog + insulin degludec with or without metformin	Droga: Insulin degludec Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Droga: Metformin Only participants who took metformin before the study should take metformin tablets, same dose as before the study Droga: Insulin aspart Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Grupo de participantes/brazo

Intervención / Tratamiento

Experimental: Faster aspart + insulin degludec with or without metformin

Droga: Faster-acting insulin aspart

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

Droga: Insulin degludec

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

Droga: Metformin

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

Comparador activo: NovoRapid/NovoLog + insulin degludec with or without metformin

Droga: Insulin degludec

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

Droga: Metformin

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

Droga: Insulin aspart

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change in Glycosylated Haemoglobin (HbA1c) Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change From Baseline in 1-hour PPG Increment Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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]) Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novo Nordisk A/S

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de septiembre de 2017

Finalización primaria (Actual)

7 de enero de 2019

Finalización del estudio (Actual)

29 de enero de 2019

Fechas de registro del estudio

Enviado por primera vez

29 de agosto de 2017

Primero enviado que cumplió con los criterios de control de calidad

29 de agosto de 2017

Publicado por primera vez (Actual)

31 de agosto de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de enero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

6 de enero de 2022

Última verificación

1 de enero de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

NN1218-4113
U1111-1180-0636 (Otro identificador: World Health Organization (WHO))
2016-000878-38 (Identificador de registro: European Medicines Agency (EudraCT))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Sí

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Diabetes Mellitus, Tipo 2

NCT07493707

Activo, no reclutando

Efecto de una intervención con vinagre de sidra de manzana en la variabilidad glucémica y el perfil lipídico en pacientes con diabetes mellitus tipo 2 (Apple vinegar)

Diabetes Mellitus Tipo 2 2
NCT07622628

Reclutamiento

AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes (AIM-MET)

Diabetes tipo 2 | Diabetes mellitus tipo 2
NCT07197788

Aún no reclutando

Acceso continuo al sistema Endogenex para los participantes en el estudio fundamental recet

Diabetes Mellitus, Tipo 2 | Diabetes | Diabetes mellitus tipo 2 | Diabetes tipo 2 | Diabetes tipo 2
NCT07197775

Aún no reclutando

Registro de vigilancia posterior al mercado para el sistema Endogenex (Registro de pulso de Endogenex)

Diabetes Mellitus, Tipo 2 | Diabetes | Diabetes tipo 2 | Diabetes mellitus tipo 2 (DM2) | Diabetes tipo 2
NCT07250789

Reclutamiento

Evaluación Cognitiva e Intervención Multidominio Dirigida al Deterioro Cognitivo en la Diabetes Tipo 2 (El Estudio de Cuidado Cerebral)

Diabetes | Deterioro Cognitivo | Diabetes tipo 2 | Diabetes mellitus tipo 2 | Deterioro cognitivo | Diabetes mellitus tipo 2 (DM2)
NCT07117721

Aún no reclutando

Ligación de banda endoscópica para diabetes mellitus tipo 2 (Endoband-DM) (ENDOBAND-DM)

Diabetes mellitus tipo 2 (DM2)
NCT06960512

Aún no reclutando

Intervenciones de estilo de vida de precisión guiadas por monitoreo continuo de glucosa: impacto en los resultados glucémicos en la diabetes mellitus tipo 2

Diabetes mellitus tipo 2 (DM2)
NCT06939413

Reclutamiento

Manejo de diabetes utilizando monitores de glucosa continuos y monitoreo remoto de pacientes en poblaciones desatendidas (DCMP)

Diabetes mellitus tipo 2 (DM2)
NCT06912737

Aún no reclutando

Intervención conductual grupal centrada en la emoción para la angustia de diabetes/A1C en la diabetes T2.

DM2 (Diabetes Mellitus Tipo 2)
NCT06789302

Aún no reclutando

Un ensayo clínico de fase IIa doble ciego, aleatorizado, controlado con placebo para evaluar la seguridad y la eficacia de DT2-SCT en sujetos con diabetes mellitus tipo 2

Diabetes mellitus tipo 2 (DM2)

Ensayos clínicos sobre Faster-acting insulin aspart

NCT07560150

Reclutamiento

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers

Farmacocinética | Farmacodinamia | Insulin Aspart
NCT05539872

Terminado

Comparación de la biosimilitud farmacocinética (PK) y farmacodinámica (PD) de la insulina aspart de acción rápida biosimilar propuesta (I004) y NovoLog después de la administración subcutánea de dosis única a voluntarios sanos

Farmacocinética | Farmacodinamia
NCT01966978

Terminado

El efecto de la titulación simple de insulina basal, metformina más liraglutida para la diabetes tipo 2 con HbA1c muy elevada - El estudio SIMPLE (SIMPLE)

Diabetes Mellitus, Tipo 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)

Descripción general del estudio

Estado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Inscripción (Actual)

Fase

Contactos y Ubicaciones

Ubicaciones de estudio

Criterios de participación

Criterio de elegibilidad

Edades elegibles para estudiar

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Descripción

Plan de estudios

¿Cómo está diseñado el estudio?

Detalles de diseño

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo

Intervención / Tratamiento

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Medidas de resultado secundarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Colaboradores e Investigadores

Patrocinador

Publicaciones y enlaces útiles

Publicaciones Generales

Fechas de registro del estudio

Fechas importantes del estudio

Inicio del estudio (Actual)

Finalización primaria (Actual)

Finalización del estudio (Actual)

Fechas de registro del estudio

Enviado por primera vez

Primero enviado que cumplió con los criterios de control de calidad

Publicado por primera vez (Actual)

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

Última actualización enviada que cumplió con los criterios de control de calidad

Última verificación

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Ensayos clínicos sobre Diabetes Mellitus, Tipo 2

Ensayos clínicos sobre Faster-acting insulin aspart

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones