An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes

Обзор

An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients with Type 2 Diabetes Primary Research Objective • To evaluate the safety of Henagliflozin in Chinese patients with type 2 diabetes mellitus (T2DM) in real world. Exploratory Research Objectives * 1\. Improvement in metabolic parameters: To assess changes in metabolic indicators, including glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG), blood pressure, and body weight, in T2DM patients treated with Henagliflozin. * 2\. Incidence of specific adverse events: To investigate the occurrence of key adverse events, with a focus on hypovolemia, amputation or amputation risk, fractures, urinary tract infections, genital infections, renal impairment, diabetic ketoacidosis, hepatic dysfunction, and severe hypoglycemia. * 3\. Impact on muscle health: To evaluate changes in muscle health indicators, such as skeletal muscle mass index, lean body mass, and grip strength, in T2DM patients receiving Henagliflozin therapy.

Вмешательства

• Другое No Intervention: Observational Cohort
  Observation study

Первичные конечные точки

• incidence of adverse events and serious adverse events during 24 weeks of treatment [Срок оценки: 24 weeks]

Вторичные конечные точки (9)

• changes of HbA1c (mmol/L) in T2DM patients during treatment with Henagliflozin [Срок оценки: 24 weeks]
• changes of fasting plasma glucose (FPG) in T2DM patients during treatment with Henagliflozin [Срок оценки: 24 weeks]
• changes of 2-hour postprandial plasma glucose (PPG) in T2DM patients during treatment with Henagliflozin [Срок оценки: 24 weeks]
• changes of blood pressure in T2DM patients during treatment with Henagliflozin [Срок оценки: 24 weeks]
• changes of weight in T2DM patients during treatment with Henagliflozin [Срок оценки: 24 weeks]
• incidence of specific adverse events during 24 weeks of treatment [Срок оценки: 24 weeks]
• changes of limb skeletal muscle mass index in T2DM patients during treatment with Henagliflozin [Срок оценки: 24 weeks]
• changes of lean body mass in T2DM patients during treatment with Henagliflozin lean body mass [Срок оценки: 24 weeks]
• changes of grip strength in T2DM patients during treatment with Henagliflozin [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 18 years old≤ age ≤ 80 years old;
• Diagnosed with type 2 diabetes mellitus according to WHO diagnostic criteria, currently receiving or eligible for add-on therapy with Henagliflozin;
• Voluntarily participate in this study and sign the informed consent form. If the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.

Критерии исключения

• Participation in or current enrollment in clinical trials investigating other glucose-lowering medications within 1 month prior to the initiation of this study.
• Current or history of recurrent urinary tract infections (UTIs) and/or genital infections.
• Patients judged by the investigator to be unsuitable to participate in this clinical trial, with considerations such as current blood volume status, estimated glomerular filtration rate (eGFR), and other clinical parameters.

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

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 7 центров

• The People's Hospital of Beihai — Beihai
• Guilin Municipal Hospital of Traditional Chinese Medicine — Guilin
• Nanxishan Hospital of Guangxi Zhuang Autonomous Region — Nanning
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning
• the Second Affiliated Hospital of Guangxi Medical University — Nanning
• Qingdao Aikangyi Internet Hospital — Qingdao

Идентификаторы

NCT: NCT06959030 · MA-DM-Ⅳ-012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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