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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Henagliflozin in Chinese adults with type 2 diabetes mellitus (T2DM). This observational study aims to monitor how this medication impacts metabolic parameters like blood sugar levels, blood pressure, and body weight, as well as its side effects. The study also explores how Henagliflozin affects muscle health, including muscle mass and strength, in real-world use. Participants will receive Henagliflozin as part of their usual care, and the study involves observing these patients without changing their treatment. The main focus is to track adverse events and serious side effects over a 24-week treatment period. Researchers will also assess changes in glycated hemoglobin (HbA1c), fasting plasma glucose, post-meal glucose, blood pressure, weight, and muscle health markers during this time. Throughout the 24 weeks, participants will be monitored regularly for safety and treatment effects. Data on adverse events, metabolic changes, and muscle health will be collected to understand the medication's impact. The study is sponsored by the Second Affiliated Hospital of Guangxi Medical University and is planned to start in June 2025, with the final results expected by September 2026.
CONDITIONS
Brief 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 by WHO criteria
- Currently receiving or eligible for add-on therapy with Henagliflozin
- Voluntary participation with signed informed consent; a witness is required if the participant cannot read the consent form
You will not qualify if you...
- Participation in other glucose-lowering drug clinical trials within 1 month before this study
- History or current recurrent urinary tract infections or genital infections
- Investigator judged unsuitable due to blood volume status, kidney function, or other clinical parameters
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants who undergo routine care with Henagliflozin are observed to assess safety and efficacy.
Regular visits during 24 weeks of treatment
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
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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