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Набира участници Фаза 3 NCT07076199

A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Фаза 3 – широко изпитване преди одобрение
Заболявания: Diabetes Mellitus, Type 1

Спонсор: Novo Nordisk A/S

Налично на: БГ
Обобщение
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.
Кой може да участва
Inclusion Criteria: * Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening. * Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening. * HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis. * Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Previous participation in this study. Participation is defined as signed informed consent. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening. * Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids). * Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Места на провеждане 8
Австралия (1)
Macquarie University - Clinical Trials Unit
Macquarie Park , New South Wales
Канада (1)
Centricity Research Calgary Endocrinology
Calgary , Alberta
Германия (1)
Diabetespraxis Mergentheim
Bad Mergentheim
COMPLETED
Полша (1)
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow , Lesser Poland Voivodeship
Puerto Rico (1)
Centro de Endo Altagracia
Bayamón
Румъния (1)
S.C. Top Diabet Srl
Craiova , Dolj
Словакия (1)
DIABEDA s.r.o.
Bratislava
САЩ (1)
Cullman Clinical Trials
Cullman , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
11.08.2025
Крайна дата
01.03.2027
Регистрационен номер
NCT07076199
Източник
anzctr
Запитване за медицински туризъм

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