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Идёт набор NCT06642623

A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients

Фаза IV С лечением Diabetes Mellitus, Type 2 Cardiovascular Diseases Kidney Diseases

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: Enavogliflozin, Dapagliflozin or Empagliflozin.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 2, Cardiovascular Diseases, Kidney Diseases. 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 Prospective, Open, Registry-based Randomized, Controlled, Investigator Initiated Trial of Enavogliflozin(ENVlo) to EvaLuate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients (ENVELOP Study)

Обзор

The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor, enavogliflozin, effectively reduces glycated hemoglobin (HbA1c) levels and body weight without increasing the risk of serious adverse events. However, its long-term clinical benefits concerning cardiovascular and renal outcomes have yet to be thoroughly studied. This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults aged 19 or older with type 2 diabetes who have a history of, or are at risk for, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular and renal events. This trial aims to determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with type 2 diabetes and cardiovascular risk factors. It will also clarify role of enavogliflozin in preventing vascular complications in this patient population.

Подробное описание

The ENVELOP study aims to assess cardiorenal outcomes following enavogliflozin administration compared with dapagliflozin or empagliflozin in Korean patients with type 2 diabetes, representing the first large-scale SGLT2 inhibitor outcome study targeting this population.

Вмешательства

  • Препарат Enavogliflozin
    The dosage and administration method are determined according to the investigator's judgment, considering the drug's approval requirements and the medical condition of the study participants.
  • Препарат Dapagliflozin or Empagliflozin
    The dosage and administration method are determined according to the investigator's judgment, considering the drug's approval requirements and the medical condition of the study participants.

Первичные конечные точки

  • Time from randomization to first onset of cardiorenal composite outcome event [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 month]
Вторичные конечные точки (8)
  • Time from randomization to the first onset of 3-point MACE and proportion of the patients [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 months]
  • death from any cause [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 months]
  • death from cardiovascular causes [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 months]
  • hospitalization due to unstable angina [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 months]
  • hospitalization due to heart failure [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 months]
  • coronary or peripheral revascularization [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 months]
  • major renal events [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 months]
  • progression of macroalbuminuria [Срок оценки: 6 months, 12 months, 24 months, 36 months and 48 months]

Критерии участия

Критерии включения

  • Male and female adults aged 19 years and older at screening
  • Subjects diagnosed with T2D at screening
  • Subjects on treatment with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within the scope of label and reimbursement criteria

Критерии исключения

  • Subjects with different types of diabetes mellitus other than T2D
  • Subjects with moderate to severe hepatic impairment
  • Subjects with contraindications to SGLT-2 inhibitors, i.e., kidney function disorders with estimated glomerular filtration (eGFR) <60 mL/min/1.73 m2, end stage renal disease (ESRD), or on dialysis
  • Subjects with major comorbidities
  • Subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components
  • Pregnant or breastfeeding women

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

Центры проведения

South Korea · 1 центр
  • Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Se — Seoul

Идентификаторы

NCT: NCT06642623 · 4-2023-1334

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗