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NCT06959030

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

Recruiting now Last updated 8 July 2025
What this trial tests

trial testing No Intervention: Observational Cohort in Type 2 Diabetes Mellitus (T2DM) in 10,000 participants. Currently enrolling.

Timeline
19 June 2025
Primary endpoint
1 September 2026
1 September 2026

Quick facts

Lead sponsorSecond Affiliated Hospital of Guangxi Medical University
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment10,000
Start date19 June 2025
Primary completion1 September 2026
Estimated completion1 September 2026
Sites7 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital of Guangxi Medical University

Who can join

Adults 18 to 80, any sex, with Type 2 Diabetes Mellitus (T2DM). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of No Intervention: Observational Cohort

Trials testing the same drug.

Other recruiting trials for Type 2 Diabetes Mellitus (T2DM)

Currently open trials in the same condition.

Other Second Affiliated Hospital of Guangxi Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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