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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 janvier 2022 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

1264

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Faster aspart + insulin degludec with or without metformin
Médicament: Faster-acting insulin aspart
Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Médicament: Insulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Médicament: Metformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Comparateur actif: NovoRapid/NovoLog + insulin degludec with or without metformin
Médicament: Insulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Médicament: Metformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Médicament: Insulin aspart
Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Glycosylated Haemoglobin (HbA1c)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in 1-hour PPG Increment
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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])
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Weeks 0-16

ADA classification of hypos:

  1. 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.
  2. Documented symptomatic: PG ≤3.9 mmol/L with symptoms.
  3. Asymptomatic: PG ≤3.9 mmol/L without symptoms.
  4. Probable symptomatic: No measurement with symptoms.
  5. Pseudo: PG >3.9 mmol/L with symptoms.
  6. Unclassifiable.

NN classification of hypos:

  1. BG confirmed: PG <3.1 mmol/L with/without symptoms.
  2. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.
  3. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.
  4. 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

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Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 septembre 2017

Achèvement primaire (Réel)

7 janvier 2019

Achèvement de l'étude (Réel)

29 janvier 2019

Dates d'inscription aux études

Première soumission

29 août 2017

Première soumission répondant aux critères de contrôle qualité

29 août 2017

Première publication (Réel)

31 août 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NN1218-4113
  • U1111-1180-0636 (Autre identifiant: World Health Organization (WHO))
  • 2016-000878-38 (Identificateur de registre: European Medicines Agency (EudraCT))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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