Semaglutide Treatment in Type 1 Diabetes
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: Semaglutide 2.4mg, Semaglutide placebo.
- Кому может быть актуально
- Состояния в реестре: Obesity in Diabetes, Obesity/Therapy, Type 1 Diabetes Mellitus (T1DM), Insulin Sensitivity/Resistance. 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
- Дания
- 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
Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial
Обзор
The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.
Подробное описание
This is a multicentre, randomised, double-blinded, placebo-controlled and investigator-initiated trial aimed to investigate the efficacy of semaglutide in patients with Type 1 Diabetes.
Patients from all included diabetes care centres will at routine visits be screened for eligibility for the trial and offered participation. If accepted, the patients will be randomised to one of two intervention arms and undergo a series of different examinations prior to start of the intervention.
The two arms consist of treatment with subcutaneous semaglutide injections or subcutaneous injections with semaglutide placebo. The baseline examinations entail documentation of insulin doses, dietary patterns, diabetes distress and treatment satisfaction questionnaires, anthropoimetric data (height, weight and calculation of BMI, waist circumference, waist-hip-ratio), blood work (HbA1c, fasting glucose, fasting c-peptide, lipids, liver and kidney markers incl. Fib-4-scoring, hematology, hsCRP), ECG, capturing of data from continuous/flash glucose monitors.
The first 40 included in the study from the centres of SDCA and NOH will further be examined through hyperinsulinemic euglycemic clamps to determine their insulin sensitivity and asses their transcriptome through muscle and fat cell biopsies in relation to the clamp and also be assessed through DXA scans to look at body composition and bone density.
Patients will then be handed out their trial drug-pens and start the uptitration proces.
The efficacy of semaglutide will be evaluated through the above mentioned array of different investigations by comparing parameters prior to trial drug start, during (throughout the study period), at the end of the drug and at a 6 week post-study followup in an intention-to-treat analysis primarily and secondarily a per-protocol analysis.
The safety will be assessed through evaluation of standardized adverse event reporting (including hypoglycemic events and diabetic ketoacidosis).
Вмешательства
- Препарат Semaglutide 2.4mg
The active comparator of the intervention is s.c. Semaglutide injection once a week in increasing doses every month from 0.25 mg to 0.5 mg to 1.0 mg to 1.7 mg to 2.4 mg and the placebo comparator is s.c. injection with a visually identical and same label pen as described for the active comparator - Препарат Semaglutide placebo
Visually identical and same label as the active comparator intervention
Первичные конечные точки
- Body weight [Срок оценки: 74 weeks]
Вторичные конечные точки (12)
- Systolic blood pressure [Срок оценки: 74 weeks]
- Diastolic blood pressure [Срок оценки: 74 weeks]
- Resting heart rate [Срок оценки: 74 weeks]
- Waist circumference [Срок оценки: 74 weeks]
- Hip-waist-ratio [Срок оценки: 74 weeks]
- Hemoglobin [Срок оценки: 74 weeks]
- Leucocytes [Срок оценки: 74 weeks]
- Thrombocytes [Срок оценки: 74 weeks]
- HbA1c [Срок оценки: 74 weeks]
- Fasting plasma-glucose [Срок оценки: 74 weeks]
- Fasting c-peptide [Срок оценки: 74 weeks]
- Total cholesterol [Срок оценки: 74 weeks]
Критерии участия
Критерии включения
- Type 1 Diabetes for more than 3 years
- BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis
Критерии исключения
- Treated with GLP1-RAs within last 6 months
- Known intolerance for semaglutide
- Other forms of diabetes
- Pregnant or nursing women
- Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives
- Liver disease with elevated plasma alanine aminotransferase (ALT) > five times and plasma aspartate aminotransferase (AST) > five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- Acute or chronic pancreatitis
- Cancer, unless in complete remission for > 5 years or unless basocellular carcinomas
- History of thyroid adenoma or carcinoma
- Alcohol/drug abuse
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Receipt of an investigational drug within 30 days prior to visit 0 / Simultaneous participation in any other clinical intervention trial
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Nordsjaellands Hospital — Hillerød
Идентификаторы
NCT: NCT06909006 · U1111-1304-0713