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Идёт набор NCT06838286

Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes

— 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: SGLT2 inhibitor, Thiazolidinedione, DPP-4 inhibitor.
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 Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients

Обзор

A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.

Подробное описание

The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin.

Participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.

The 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.

Вмешательства

  • Препарат SGLT2 inhibitor
    SGLT2 inhibitor class of drugs
  • Препарат Thiazolidinedione
    Thiazolidinedione class of drugs
  • Препарат DPP-4 inhibitor
    DPP4 inhibitor class of drugs

Первичные конечные точки

  • Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs. [Срок оценки: 24 month]
Вторичные конечные точки (5)
  • Changes in HbA1c [Срок оценки: 3, 6, (9), 12, 18, and 24 months]
  • Changes in FPG [Срок оценки: 3, 6, (9), 12, 18, and 24 months]
  • Percentage of Subjects with HbA1c < 7.0% [Срок оценки: 3, 6, (9), 12, 18, and 24 months]
  • Percentage of Subjects with HbA1c < 6.5% [Срок оценки: 3, 6, (9), 12, 18, and 24 months]
  • Factors influencing HbA1c change at each endpoint for each combination group. [Срок оценки: 24 month]

Критерии участия

Критерии включения

  • Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
  • Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
  • 7.0% ≤ HbA1c < 10.0% based on laboratory tests performed within 4 weeks of enrollment.
  • Voluntarily give written informed consent after being told about the study.

Критерии исключения

  • Patients with type 1 diabetes and secondary diabetes.
  • Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
  • Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
  • End-stage renal disease and hemodialysis patients.
  • diabetic ketoacidosis Patients.
  • Pregnant and lactating women.
  • Patients who are contraindicated by any of the "Precautions for Use" in the license for the drug being administered during the study, given the observational nature of the study under routine practice.
  • Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
  • Anyone else deemed by the investigator to be unsuitable for participation in the study.

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
  • Seoul National University Bundang Hospital — Seongnam-si

Идентификаторы

NCT: NCT06838286 · D141_01DM2303

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗