NCT06959030Recruiting
An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 16 Apr 2025
- Start date
- 19 Jun 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Second Affiliated Hospital of Guangxi Medical University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06959030
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 19 Jun 2025 to the primary completion date, 1 Sept 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current or history of recurrent urinary tract infections (UTIs) and/or genital infections.
Lab values
- Participation in or current enrollment in clinical trials investigating other glucose-lowering medications within 1 month prior to the initiation of this study.
- 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.
Who the study is looking for
- 18 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.
Age in the registry: 18 years to 80 years · Sex: All
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The People's Hospital of Beihai Coordinator of this site? Confirm its status | Beihai | China | Not yet recruiting |
| Guilin Municipal Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guilin | China | Not yet recruiting |
| The People's Hospital of Guangxi Zhuang Autonomous Region Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| The Second Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Nanxishan Hospital of Guangxi Zhuang Autonomous Region Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| Qingdao Aikangyi Internet Hospital Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.