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Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Henagliflozin safety and effects in Chinese adults with type 2 diabetes

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

Run by Second Affiliated Hospital of Guangxi Medical University · NCT06959030 · Data updated 2026-11-12

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.

More Type 2 Diabetes Mellitus (T2DM) trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment10000 (estimated)
SponsorSecond Affiliated Hospital of Guangxi Medical University
Academic / other
Locations7 sites (Beihai, Guangxi and 6 other locations)
StatusRecruiting
StartedJune 19, 2025
Main results expectedSeptember 1, 2026
Study endsSeptember 1, 2026
Registry record updatedJuly 8, 2025
Trial IDNCT06959030 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • the Second Affiliated Hospital of Guangxi Medical University
    Nanning, Guangxi, China     Recruiting
  • 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
Show 1 more location
  • Qingdao Aikangyi Internet Hospital
    Qingdao, Shandong, China     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Type 2 Diabetes Mellitus (T2DM) 68Second Affiliated Hospital of Guangxi Medical University 2
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.