Observes safety of henagliflozin in Chinese adults with type 2 diabetes
Studies how henagliflozin is used and its safety in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes
Key facts
- Where
- Beihai, Guilin, Nanning, and Qingdao, ChinaSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06959030, who can take part
Where in China
- The People's Hospital of BeihaiBeihai, ChinaNot yet recruiting
- Guilin Municipal Hospital of Traditional Chinese MedicineGuilin, ChinaNot yet recruiting
- Nanxishan Hospital of Guangxi Zhuang Autonomous RegionNanning, ChinaNot yet recruiting
- The People's Hospital of Guangxi Zhuang Autonomous RegionNanning, ChinaNot yet recruiting
- The Second Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
- Qingdao Aikangyi Internet HospitalQingdao, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital of Guangxi Medical University
- Trial code
- NCT06959030
- Record updated
- 8 July 2025
- Original description
An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients with Type 2 Diabetes Primary Research ObjectiveRead full original descriptionShow less
An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes
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.
Inclusion: 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.
Exclusion: Current or history of recurrent urinary tract infections (UTIs) and/or genital infections; 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.