Идёт набор 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 III С лечением Diabetes Mellitus, Type 1

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Insulin icodec, Insulin glargine, Insulin aspart.
Кому может быть актуально: Состояния в реестре: Diabetes Mellitus, Type 1. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия, Канада, Германия, Польша +3
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Обзор

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.

Вмешательства

Препарат Insulin icodec
Insulin icodec will be administered as subcutaneous injection
Препарат Insulin glargine
Insulin glargine will be administered as subcutaneous injection.
Препарат Insulin aspart
Insulin aspart will be administered as a subcutaneous injection.

Первичные конечные точки

Change in glycosylated haemoglobin (HbA1c) [Срок оценки: From baseline (week 0) to week 26]

Вторичные конечные точки (9)

Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) [Срок оценки: From baseline (week-2-0) to week 22-26]
Time spent less than (<)3.0 mmol/L (54 mg/dL) [Срок оценки: From week 22 to week 26]
Change in time spent greater than (>)10.0 mmol/L (180 mg/dL) [Срок оценки: From baseline (week-2-0) to week 22-26]
Number of severe hypoglycaemic episodes (level 3) [Срок оценки: From baseline (week 0) to week 31]
Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter) [Срок оценки: From baseline (week 0) to week 31]
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3) [Срок оценки: From baseline (week 0) to week 31]
Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]) [Срок оценки: From baseline (week 0) to week 31]
Mean total weekly insulin dose [Срок оценки: From week 24 to week 26]
Change in body weight [Срок оценки: From baseline (week 0) to week 26]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Открытое
Основная цель: Лечение