NCT06818851 The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy
| NCT ID | NCT06818851 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 64 participants in total. It began in 2025-07-14 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with type 2 diabetes mellitus (T2DM) 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 (with or without oral antidiabetic drugs) within the 3 months prior to screening. * HbA1c level above 8%. * BMI ≥ 20 kg/m². * 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 methods, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form. Exclusion Criteria: * Patients considered by the investigator to have potential allergies to the components of the study drug or drugs of the same class. * Use of SGLT2 inhibitors or GLP-1 receptor agonists within 3 months prior to screening. * Adjustments to antidiabetic treatment regimens within 3 months prior to screening. * Hospitalization due to acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 30 days prior to the screening visit. * Volume depletion. * Chronic (\>2 weeks) systemic glucocorticoid therapy or use of glucocorticoids within 4 weeks prior to screening (except for topical, intraocular, intranasal, or inhaled administration). * 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 (estimated glomerular filtration rate \[eGFR\] \< 45 mL/min/1.73 m²). * History of malignant tumors. * Presence of acute complications (e.g., ketoacidosis, diabetic ketoacidosis, lactic acidosis, or hyperosmolar coma). * Systemic autoimmune diseases, such as systemic lupus erythematosus. * Clinically significant urinary tract infections and/or genital infections, or a history of recurrent urinary tract and/or genital infections. * Any other factors deemed by the investigator to potentially affect the efficacy or safety evaluation of the study. * Participation in other clinical trials and receipt of investigational drugs within 3 months prior to screening.
Contact & Investigator
Qing Su
STUDY DIRECTOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT06818851 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 70 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06818851 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06818851 currently recruiting?
Yes, NCT06818851 is actively recruiting participants. Contact the research team at spicygirlss@126.com for enrollment information.
Where is the NCT06818851 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06818851 clinical trial?
NCT06818851 is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The principal investigator is Qing Su at Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 64 participants.
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