The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy

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.

NCT Number	NCT06818851
Lead Sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Conditions	Diabetes Mellitus, Type 2
Enrollment	64 participants
Start Date	2025-07-14
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-03-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-20