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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 de janeiro de 2022 atualizado 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).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

1264

Estágio

Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Alemanha
- - Dresden, Alemanha, 01219
    - Novo Nordisk Investigational Site
  - Essen, Alemanha, 45136
    - Novo Nordisk Investigational Site
  - Falkensee, Alemanha, 14612
    - Novo Nordisk Investigational Site
  - Lingen, Alemanha, 49808
    - Novo Nordisk Investigational Site
  - Münster, Alemanha, 48145
    - Novo Nordisk Investigational Site
  - Saint Ingbert-Oberwürzbach, Alemanha, 66386
    - Novo Nordisk Investigational Site
  - Schweinfurt, Alemanha, 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
Bulgária
- - Kozloduy, Bulgária, 3320
    - Novo Nordisk Investigational Site
  - Razgrad, Bulgária, 7200
    - Novo Nordisk Investigational Site
  - Sofia, Bulgária, 1233
    - Novo Nordisk Investigational Site
  - Sofia, Bulgária, 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
Croácia
- - Karlovac, Croácia, 47000
    - Novo Nordisk Investigational Site
  - Osijek, Croácia, 31 000
    - Novo Nordisk Investigational Site
  - Varazdin, Croácia, 42 000
    - Novo Nordisk Investigational Site
  - Zagreb, Croácia, 10 000
    - Novo Nordisk Investigational Site
Eslováquia
- - Kosice, Eslováquia, 040 01
    - Novo Nordisk Investigational Site
  - Kysucke Nove Mesto, Eslováquia, 024 01
    - Novo Nordisk Investigational Site
  - Lubochna, Eslováquia, 03491
    - Novo Nordisk Investigational Site
  - Lucenec, Eslováquia, 984 01
    - Novo Nordisk Investigational Site
  - Zilina, Eslováquia, 01001
    - Novo Nordisk Investigational Site
Espanha
- - Alcobendas, Espanha, 28100
    - Novo Nordisk Investigational Site
  - Almería, Espanha, 04001
    - Novo Nordisk Investigational Site
  - Girona, Espanha, 17007
    - Novo Nordisk Investigational Site
  - La Coruña, Espanha, 15006
    - Novo Nordisk Investigational Site
  - Pozuelo de Alarcon, Espanha, 28223
    - Novo Nordisk Investigational Site
  - Sabadell, Espanha, 08208
    - Novo Nordisk Investigational Site
  - Sevilla, Espanha, 41010
    - Novo Nordisk Investigational Site
  - Sevilla, Espanha, 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
Federação Russa
- - Arkhangelsk, Federação Russa, 163045
    - Novo Nordisk Investigational Site
  - Kazan, Federação Russa, 420073
    - Novo Nordisk Investigational Site
  - Moscow, Federação Russa, 123448
    - Novo Nordisk Investigational Site
  - Penza, Federação Russa, 440026
    - Novo Nordisk Investigational Site
  - Saint Petersburg, Federação Russa, 194291
    - Novo Nordisk Investigational Site
  - Saint-Petersburg, Federação Russa, 194356
    - Novo Nordisk Investigational Site
  - Tumen, Federação Russa, 625023
    - Novo Nordisk Investigational Site
  - Voronezh, Federação Russa, 394018
    - Novo Nordisk Investigational Site
Grécia
- - Athens, Grécia, GR-11527
    - Novo Nordisk Investigational Site
  - Athens, Grécia, 115 25
    - Novo Nordisk Investigational Site
  - Ioannina, Grécia, 45500
    - Novo Nordisk Investigational Site
  - Larissa, Grécia, GR-41110
    - Novo Nordisk Investigational Site
  - Thessaloniki, Grécia, GR-54636
    - Novo Nordisk Investigational Site
  - Thessaloniki, Grécia, GR-57001
    - Novo Nordisk Investigational Site
  - Thessaloniki, Grécia, GR-54642
    - Novo Nordisk Investigational Site
  - Thessaloniki, Grécia, GR-54643
    - Novo Nordisk Investigational Site
Itália
- - Catanzaro, Itália, 88100
    - Novo Nordisk Investigational Site
  - Chieti, Itália, 66100
    - Novo Nordisk Investigational Site
  - Cittadella (PD), Itália, 35013
    - Novo Nordisk Investigational Site
  - Milano (MI), Itália, 20132
    - Novo Nordisk Investigational Site
  - Olbia, Itália, 07026
    - Novo Nordisk Investigational Site
  - Palermo, Itália, 90129
    - Novo Nordisk Investigational Site
Polônia
- - Bialystok, Polônia, 15-435
    - Novo Nordisk Investigational Site
  - Skorzewo, Polônia, 60-185
    - Novo Nordisk Investigational Site
  - Warsaw, Polônia, 00-465
    - Novo Nordisk Investigational Site
  - Warsaw, Polônia, 02-793
    - Novo Nordisk Investigational Site
  - Warszawa, Polônia, 02-507
    - Novo Nordisk Investigational Site
  - Wroclaw, Polônia, 50-381
    - Novo Nordisk Investigational Site
Porto Rico
- - Ponce, Porto Rico, 00716
    - Novo Nordisk Investigational Site
Republica da Coréia
- - Bucheon, Republica da Coréia, 14647
    - Novo Nordisk Investigational Site
  - Daegu, Republica da Coréia, 42472
    - Novo Nordisk Investigational Site
  - Seongnam-si, Republica da Coréia, 463-707
    - Novo Nordisk Investigational Site
  - Seoul, Republica da Coréia, 02447
    - Novo Nordisk Investigational Site
  - Seoul, Republica da Coréia, 03080
    - Novo Nordisk Investigational Site
  - Seoul, Republica da Coréia, 04516
    - Novo Nordisk Investigational Site
  - Seoul, Republica da Coréia, 06351
    - Novo Nordisk Investigational Site
  - Seoul, Republica da Coréia, 08308
    - Novo Nordisk Investigational Site
  - Seoul, Republica da Coréia, 137-701
    - Novo Nordisk Investigational Site
  - Wonju, Republica da Coréia, 26426
    - Novo Nordisk Investigational Site
Romênia
- - Brasov, Romênia, 500101
    - Novo Nordisk Investigational Site
  - Brasov, Romênia, 500283
    - Novo Nordisk Investigational Site
  - Bucharest, Romênia, 13682
    - Novo Nordisk Investigational Site
- Maramures
  - Baia Mare, Maramures, Romênia, 430222
    - Novo Nordisk Investigational Site
- Mures
  - Tirgu Mures, Mures, Romênia, 540142
    - Novo Nordisk Investigational Site
- Timis
  - Timisoara, Timis, Romênia, 300125
    - Novo Nordisk Investigational Site
Sérvia
- - Belgrade, Sérvia, 11000
    - Novo Nordisk Investigational Site
  - Kragujevac, Sérvia, 34000
    - Novo Nordisk Investigational Site
  - Nis, Sérvia, 18000
    - Novo Nordisk Investigational Site
  - Novi Sad, Sérvia, 21000
    - Novo Nordisk Investigational Site
  - Zajecar, Sérvia, 19000
    - Novo Nordisk Investigational Site
Tcheca
- - Hradec Kralove, Tcheca, 500 05
    - Novo Nordisk Investigational Site
  - Plzen, Tcheca, 30100
    - Novo Nordisk Investigational Site
  - Plzen, Tcheca, 32600
    - Novo Nordisk Investigational Site
  - Trutnov, Tcheca, 541 01
    - Novo Nordisk Investigational Site
Ucrânia
- - Dnipro, Ucrânia, 49038
    - Novo Nordisk Investigational Site
  - Kharkiv, Ucrânia, 61000
    - Novo Nordisk Investigational Site
  - Kyiv, Ucrânia, 03049
    - Novo Nordisk Investigational Site
  - Lviv, Ucrânia, 79010
    - Novo Nordisk Investigational Site
  - Ternopil, Ucrânia, 46002
    - Novo Nordisk Investigational Site
  - Vinnytsia, Ucrânia, 21010
    - Novo Nordisk Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Alocação: Randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Quadruplicar

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Experimental: Faster aspart + insulin degludec with or without metformin	Medicamento: Faster-acting insulin aspart Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Medicamento: Insulin degludec Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Medicamento: Metformin Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Comparador Ativo: NovoRapid/NovoLog + insulin degludec with or without metformin	Medicamento: Insulin degludec Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. Medicamento: Metformin Only participants who took metformin before the study should take metformin tablets, same dose as before the study Medicamento: Insulin aspart Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Grupo de Participantes / Braço

Intervenção / Tratamento

Experimental: Faster aspart + insulin degludec with or without metformin

Medicamento: Faster-acting insulin aspart

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

Medicamento: Insulin degludec

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

Medicamento: Metformin

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

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

Medicamento: Insulin degludec

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

Medicamento: Metformin

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

Medicamento: Insulin aspart

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change in Glycosylated Haemoglobin (HbA1c) Prazo: 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 resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change From Baseline in 1-hour PPG Increment Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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) Prazo: 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]) Prazo: 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) Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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 Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novo Nordisk A/S

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de setembro de 2017

Conclusão Primária (Real)

7 de janeiro de 2019

Conclusão do estudo (Real)

29 de janeiro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

29 de agosto de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de agosto de 2017

Primeira postagem (Real)

31 de agosto de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de janeiro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de janeiro de 2022

Última verificação

1 de janeiro de 2022

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Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Faster-acting insulin aspart

University of Aarhus
Novo Nordisk A/S

Concluído

Uma Comparação da Farmacodinâmica e Farmacocinética da Insulina Aspart, Insulina Aspart Bifásica 30, 50 e 70.

Diabetes tipo 1

Dinamarca
Novo Nordisk A/S

Concluído

Um estudo de pesquisa que analisa como o aspártico injetado em dupla concentração funciona mais rápido no corpo de pessoas com diabetes mellitus tipo 1

Diabetes Mellitus, Tipo 1

Alemanha

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)

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Última verificação

Mais Informações

Termos relacionados a este estudo

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Outros números de identificação do estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Descrição do plano IPD

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Ensaios clínicos em Faster-acting insulin aspart

Pesquisar ensaios semelhantes

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