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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 января 2022 г. обновлено: 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).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

1264

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Faster aspart + insulin degludec with or without metformin
Лекарство: Faster-acting insulin aspart
Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Лекарство: Insulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Лекарство: Metformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Активный компаратор: NovoRapid/NovoLog + insulin degludec with or without metformin
Лекарство: Insulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Лекарство: Metformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Лекарство: Insulin aspart
Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Glycosylated Haemoglobin (HbA1c)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in 1-hour PPG Increment
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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])
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

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Спонсор

Novo Nordisk A/S

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

19 сентября 2017 г.

Первичное завершение (Действительный)

7 января 2019 г.

Завершение исследования (Действительный)

29 января 2019 г.

Даты регистрации исследования

Первый отправленный

29 августа 2017 г.

Впервые представлено, что соответствует критериям контроля качества

29 августа 2017 г.

Первый опубликованный (Действительный)

31 августа 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

11 января 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

6 января 2022 г.

Последняя проверка

1 января 2022 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • NN1218-4113
  • U1111-1180-0636 (Другой идентификатор: World Health Organization (WHO))
  • 2016-000878-38 (Идентификатор реестра: European Medicines Agency (EudraCT))

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Да

Описание плана IPD

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Сахарный диабет, тип 2

Клинические исследования Faster-acting insulin aspart

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