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

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

Plain Language Summary

Simplified for easier understanding

This observational study is tracking the real-world safety and effectiveness of a diabetes medication called henagliflozin (an SGLT2 inhibitor) in Chinese patients with type 2 diabetes. It is not testing a new drug — it is monitoring how well the medication works and whether it causes side effects in everyday clinical practice. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with type 2 diabetes (according to WHO criteria) - You are currently being treated with or starting henagliflozin as an add-on therapy - You are willing to participate and sign informed consent **You may NOT be eligible if...** - You have type 1 diabetes - You have severe kidney disease or other conditions that make SGLT2 inhibitors unsafe - You are pregnant or breastfeeding - You are unable or unwilling to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo Intervention: Observational Cohort

Observation study


Locations(7)

The People's Hospital of Beihai

Beihai, Guangxi, China

Guilin Municipal Hospital of Traditional Chinese Medicine

Guilin, Guangxi, China

Nanxishan Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

the Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Qingdao Aikangyi Internet Hospital

Qingdao, Shandong, China

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NCT06959030


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