RecruitingNCT06959030

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

Sponsor

Second Affiliated Hospital of Guangxi Medical University

Enrollment

10,000 participants

Start Date

Jun 19, 2025

Study Type

OBSERVATIONAL

Conditions

Type 2 Diabetes Mellitus (T2DM)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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.

Exclusion Criteria3

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.