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Идёт набор NCT07433192

POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.

— Наблюдательное Type 2 Diabetes Mellitus

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes Mellitus. 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
Россия
Следующий шаг
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Официальное название

Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.

Обзор

In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.

Подробное описание

This single-arm study is planned to include patients who, in routine clinical practice, have been prescribed 2.5 mg of Lusefi® once daily as type 2 diabetes treatment. If the response to the treatment is insufficient, the attending physician in routine clinical practice may increase the daily dose to 5 mg once daily. The total duration of observation within this study will be approximately 6 months.

Describing hypoglycemic effectiveness of luseogliflozin, its effect on the metabolic and hemodynamic parameters in patients with type 2 diabetes in real-world clinical practice.

Первичные конечные точки

  • Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin) [Срок оценки: 6 months]
Вторичные конечные точки (9)
  • Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose) [Срок оценки: 6 months]
  • Effectiveness of luseogliflozin on Body weight [Срок оценки: 6 months]
  • Effectiveness of luseogliflozin on systolic blood pressure (SBP) [Срок оценки: 6 months]
  • Effectiveness of luseogliflozin on diastolic blood pressure ( DBP) [Срок оценки: 6 months]
  • Effectiveness of luseogliflozin on filtration function of the kidneys [Срок оценки: 6 months]
  • Effectiveness of luseogliflozin on lipid profile (cholesterol ) [Срок оценки: 6 months]
  • Effectiveness of luseogliflozin on lipid profile (lipoproteins ) [Срок оценки: 6 months]
  • Effectiveness of luseogliflozin on lipid profile (triglycerides ) [Срок оценки: 6 months]
  • Effectiveness of luseogliflozin on uric acid level [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Men and women aged 18 years and older.
  • Patients with type 2 diabetes.
  • Written informed consent of the patient to participate in the study.
  • No conditions that require emergency medical aid.
  • Treatment with luseogliflozin started 7 to 30 days prior to the inclusion visit as part of routine clinical practice and in accordance with the SmPC approved in the Russian Federation.
  • Presence of data on the parameters of interest (HbA1c, eGFR, BP, body weight), dated no later than 15 days from the date the treatment with luseogliflozin was started

Критерии исключения

  • Patients cannot be included in this study if they meet at least one of the following exclusion criteria:
  • Known hypersensitivity to luseogliflozin or other components of Lusefi®.
  • Type 1 diabetes.
  • Decompensated type 2 diabetes.
  • Pregnancy, breastfeeding, or planned pregnancy during the study and at least two months after the study.
  • Severe renal failure (eGFR <30 mL/min/1.73 m2), end-stage chronic kidney disease (CKD) or dialysis, as the treatment is predicted to be ineffective in this population of patients.
  • Diabetic ketoacidosis, diabetic coma or precoma.
  • Severe infections, pre- and postoperative period, or severe injury.
  • Any suspected or confirmed malignant neoplasm, including a history of malignancy within ≤5 years prior to screening, excluding successfully treated basal cell carcinoma and squamous cell carcinoma of the skin or in situ cervical cancer.
  • Urinary tract infection (confirmed or suspected).
  • Other concomitant disorders considered by the investigator to affect the natural progression of the disease and significantly impact the treatment results.
  • Predictable unwillingness of the patient to adhere to the treatment regimen and/or cooperate with the investigator.
  • Participation of the patient in another clinical study within 3 months (6 months for biological medicinal products) prior to the inclusion visit or during this study.

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

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Россия · 1 центр
  • GBUZ hospital — Anapa

Идентификаторы

NCT: NCT07433192 · IC4-LUS-004-RUS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗