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