Henagliflozin safety and effects in Chinese adults with type 2 diabetes

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

This project will see if henagliflozin is safe and helps lower blood sugar and improve weight, blood pressure, and muscle health in Chinese adults with type 2 diabetes treated in routine clinical care.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangxi Medical University (Academic / other)
• Locations: 7 sites (Beihai, Guangxi and 6 other locations)
• Trial ID: NCT06959030 on ClinicalTrials.gov

What this trial studies

This observational cohort gathers real-world data on Chinese adults aged 18–80 with type 2 diabetes who are receiving or eligible for add-on henagliflozin therapy at three hospitals in Guangxi. Investigators will record safety outcomes and changes in metabolic measures including HbA1c, fasting and 2‑hour postprandial glucose, blood pressure, and body weight as well as muscle-related metrics like skeletal muscle mass index and grip strength. The study will specifically monitor the incidence of prespecified adverse events such as hypovolemia, amputation risk, fractures, urinary and genital infections, renal impairment, diabetic ketoacidosis, hepatic dysfunction, and severe hypoglycemia. As an observational project, participants receive routine clinical care and data are collected prospectively without mandated experimental interventions.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18–80 with diagnosed type 2 diabetes who are starting or already eligible for add-on henagliflozin therapy and can provide informed consent.

Not a fit: Patients with a history of recurrent urinary or genital infections, those recently enrolled in other glucose‑lowering drug trials, or individuals judged unsuitable by investigators due to factors like low blood volume or impaired kidney function are less likely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could clarify the real-world safety profile and metabolic effects of henagliflozin for Chinese patients, helping clinicians make informed treatment choices.

How similar studies have performed: Other SGLT2 inhibitors have demonstrated consistent glycemic, cardiovascular, and renal benefits in clinical trials, but henagliflozin has more limited published real-world safety data specifically in Chinese populations.

Eligibility criteria

Inclusion Criteria:

1. 18 years old≤ age ≤ 80 years old;
2. Diagnosed with type 2 diabetes mellitus according to WHO diagnostic criteria, currently receiving or eligible for add-on therapy with Henagliflozin;
3. 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 Criteria:

1. Participation in or current enrollment in clinical trials investigating other glucose-lowering medications within 1 month prior to the initiation of this study.
2. Current or history of recurrent urinary tract infections (UTIs) and/or genital infections.
3. 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.

Where this trial is running

Beihai, Guangxi and 6 other locations

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

Study contacts

• Study coordinator: Yuzhen Liang

Conditions Type 2 Diabetes Mellitus