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

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

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.

Conditions2

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