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Идёт набор NCT06269120

SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary

— Наблюдательное Type 2 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: Oral Semaglutide.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes. 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
Венгрия
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

SEMA-CardioDiab HUNGARY: A Multicentre, Prospective, Non-interventional Study to Evaluate Glycemic Control and Weight Changes in Patients With Type 2 Diabetes Initiating Treatment With Oral Semaglutide by Cardiologists or Diabetologists as Part of Local Clinical Practice in Hungary

Обзор

Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment.

Вмешательства

  • Препарат Oral Semaglutide
    Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician.

Первичные конечные точки

  • Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5% [Срок оценки: From Baseline to end of study (week 32)]
Вторичные конечные точки (12)
  • Change in HbA1c [Срок оценки: From Baseline to end of study (week 32)]
  • Change in fasting plasm glucose (FPG) [Срок оценки: From Baseline to end of study (week 32)]
  • Absolute change in body weight (BW) [Срок оценки: From Baseline to end of study (week 32)]
  • Relative change in BW [Срок оценки: From Baseline to end of study (week 32)]
  • HbA1c less than (<) 7.0% [Срок оценки: At end of study (week 32)]
  • HbA1c <6.5% [Срок оценки: At end of study (week 32)]
  • Body weight reduction ≥5% [Срок оценки: At end of study (week 32)]
  • HbA1c reduction ≥1%-point and BW reduction ≥5% [Срок оценки: From Baseline to end of study (week 32)]
  • HbA1c reduction ≥1%-point and BW reduction ≥3% [Срок оценки: From Baseline to end of study (week 32)]
  • Change in waist circumference [Срок оценки: From Baseline to end of study (week 32)]
  • Change in blood pressure (BP) (systolic and diastolic) [Срок оценки: From Baseline to end of study (week 32)]
  • Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG]) [Срок оценки: From Baseline to end of study (week 32)]

Критерии участия

Критерии включения

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/LAR and the treating physician based on local label before and independently from the decision to include the patient in this study.
  • Male or female, adults above or equal to 18 years of age at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus.
  • Patient on metformin (Met) with or without modern oral antidiabetic (MOAD, that is Dipeptidyl Peptidase-4 Inhibitor \[DPP4i\] or/and Sodium-glucose cotransporter-2 Inhibitor \[SGLT2i\]) with or without insulin therapy.
  • Available HbA1c value > 7.0% within 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.

Критерии исключения

  • Previous participation in this study (defined as having given informed consent in this study earlier).
  • Treatment with any investigational drug within 30 days prior to enrolment into the study.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Glucagon like peptide -1 receptor agonist (GLP1-RA) treatment within 90 days prior to the Treatment Initiation visit (V1).
  • Patients diagnosed with type 1 diabetes mellitus.
  • Female who is known to be pregnant, undergoing fertility treatment, breastfeeding or intends to become pregnant during the study duration.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Венгрия · 1 центр
  • Siklósi Kórház, Diabetológia — Siklós

Идентификаторы

NCT: NCT06269120 · NN9924-7787 · U1111-1290-8109

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗