Actively Recruiting
An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes
Led by Second Affiliated Hospital of Guangxi Medical University · Updated on 2025-07-08
10000
Participants Needed
7
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed with type 2 diabetes mellitus according to WHO criteria
- Currently receiving or eligible for Henagliflozin add-on therapy
- Willing to participate and able to provide informed consent (with witness if unable to read)
You will not qualify if you...
- Participated in other clinical trials for glucose-lowering drugs within 1 month before this study
- Current or past recurrent urinary tract or genital infections
- Considered unsuitable for the study by the investigator based on blood volume, kidney function, or other clinical factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
The People's Hospital of Beihai
Beihai, Guangxi, China
Not Yet Recruiting
2
Guilin Municipal Hospital of Traditional Chinese Medicine
Guilin, Guangxi, China
Not Yet Recruiting
3
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Not Yet Recruiting
4
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Not Yet Recruiting
5
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Not Yet Recruiting
6
the Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
7
Qingdao Aikangyi Internet Hospital
Qingdao, Shandong, China
Not Yet Recruiting
Research Team
Y
Yuzhen Liang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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