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Набор по приглашению NCT05689372

Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

— Наблюдательное Diabetes Mellitus, Type 2

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.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 2. Базовые параметры: от 19 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
South Korea
Следующий шаг
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Официальное название

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic Solution for Injection 1.34mg/ml (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

Обзор

The aim of this study is to assess the safety and effectiveness of Ozempic initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Ozempic as prescribed by study doctor. The study will last for about 26 weeks.

Вмешательства

  • Препарат Semaglutide
    Participants will receive Ozempic (solution for injection 1.34 mg/ml (Semaglutide s.c.) according to routine clinical practice conditions for 26 weeks. The physician will determine the dose of Ozempic in accordance with the K-PI.

Первичные конечные точки

  • Number (incidence) of adverse events (AEs) [Срок оценки: From baseline (week 0) to 26 weeks]
Вторичные конечные точки (7)
  • Number (incidence) of hypoglycaemia level 3 or level 2 according to American Diabetes Association (ADA) guideline 2020 [Срок оценки: From baseline (week 0) to 26 weeks]
  • Change in glycated haemoglobin (HbA1c) [Срок оценки: From baseline (week 0) to 26 weeks]
  • Participants achieving HbA1c target < 7.0 percent (%) [Срок оценки: At 26 weeks]
  • Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG) [Срок оценки: From baseline (week 0) to 26 weeks]
  • Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG) [Срок оценки: From baseline (week 0) to 26 weeks]
  • Change in body weight [Срок оценки: From baseline (week 0) to 26 weeks]
  • Dose of Ozempic [Срок оценки: At 26 weeks]

Критерии участия

Критерии включения

  • The decision to initiate treatment with commercially available Ozempic has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
  • The participant with T2DM is scheduled to start treatment with Ozempic based on the clinical judgment of their treating physician as specified in the approved label in Korea.
  • Informed consent is obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male/female age greater than or equal to (>=) 19 years at the time of signing informed consent.

Критерии исключения

  • Participants who are or have previously been on Ozempic therapy.
  • Known or suspected hypersensitivity to Ozempic, the active substance or any of the excipients.
  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Female patients who is pregnant, breast-feeding or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice).
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Wonkwang University Hospital — Jeonlabuk-do

Идентификаторы

NCT: NCT05689372 · NN9535-4666 · 1111-1243-9580

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗