Actively Recruiting
The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-07-20
64
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
X
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor
J
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if SGLT2 inhibitor Henggliflozin works to improve glucose variability in type 2 diabetes and if Henggliflozin can benefit immunosenescence. The main questions it aims to answer are: Does Henggliflozin as an add on treatment works to improve blood glucose fluctuation in type 2 diabetes? Does Henggliflozin has extra benefits like improve immunosenescence beyond hypoglycemic effects? Researchers will compare Henggliflozin to a placebo to see if Henggliflozin can improve glucose variability and immunosenescence. Participants will: Take Henggliflozin or a placebo every day for 16 weeks. Receive weekly follow-up calls to guide them in adjusting their insulin doses. Return for an on-site visit at 4 weeks and 16 weeks. Take a continuous glucose monitoring (CGM) for 7 days at the Visit 1 and at the end of the study.
CONDITIONS
Official Title
The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus for at least 6 months based on the 1999 WHO criteria.
- Age between 50 and 70 years at the time of signing the informed consent form (inclusive).
- Poor glycemic control despite treatment with basal insulin or insulin degludec/aspart within the 3 months prior to screening.
- HbA1c level above 8%.
- BMI 20 kg/m�b2 or higher.
- C-peptide levels within the normal reference range.
- Able to maintain stable dietary and exercise habits during the study.
- Capable of understanding the study procedures and willing to comply with the clinical trial protocol.
- Willing to voluntarily sign the informed consent form.
You will not qualify if you...
- Allergy to the study drug or drugs of the same class.
- Use of SGLT2 inhibitors or GLP-1 receptor agonists within 3 months prior to screening.
- Changes to antidiabetic treatment regimens within 3 months prior to screening.
- Hospitalization for acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to screening.
- Volume depletion.
- Chronic systemic glucocorticoid therapy or glucocorticoid use within 4 weeks prior to screening (except topical, intraocular, intranasal, or inhaled).
- Pregnancy, lactation, or plans for pregnancy within the next 6 months.
- Persistently elevated serum transaminase levels (more than 3 times the upper limit of normal).
- Renal impairment with eGFR below 45 mL/min/1.73 m�b2.
- History of malignant tumors.
- Acute complications like ketoacidosis, diabetic ketoacidosis, lactic acidosis, or hyperosmolar coma.
- Systemic autoimmune diseases such as systemic lupus erythematosus.
- Clinically significant urinary tract or genital infections, or history of recurrent infections.
- Any other factors that may affect the safety or efficacy evaluation.
- Participation in other clinical trials and receipt of investigational drugs within 3 months prior to screening.
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Trial Site Locations
Total: 1 location
1
Shanghai Jiaotong University School of Medicine, Xinhua Hospital
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
Research Team
H
Hongmei Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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