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.
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%.
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.
Parallel
Henggliflozin
DrugUpon enrollment, at Visit 1 (baseline), overnight fasting blood and urine samples will be collected, and glucose levels will be monitored for 3-5 days using a continuous glucose monitoring (CGM) system (Medtronic MiniMed). After the preliminary assessment, participants will receiveHenggliflozin 10 mg once daily by oral administration for up to 16 weeks.
Placebo
Other interventionUpon enrollment, at Visit 1 (baseline), overnight fasting blood and urine samples will be collected, and glucose levels will be monitored for 3-5 days using a continuous glucose monitoring (CGM) system (Medtronic MiniMed). After the preliminary assessment, participants will receive a placebo once daily by oral administration for up to 16 weeks.
Change from Baseline in the mean amplitude of glycemic excursions at 16 weeks
Change from Baseline in the immunophenotype of peripheral blood mononuclear cells at 16 weeks
Click on the lead sponsor to view all of their trials.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
