Henagliflozin added to insulin to reduce blood sugar swings and age-related immune changes in type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 50–70 with type 2 diabetes and poor control on basal insulin will receive either oral henagliflozin or placebo daily for 16 weeks alongside their usual insulin regimen. Participants will have weekly follow-up calls for insulin dose guidance and will wear a continuous glucose monitor for 7 days at baseline and again at the end of the study to measure glycemic variability (e.g., MAGE). Blood samples will be collected to measure markers of immunosenescence and routine safety labs. Outcomes will compare changes in glucose variability and immune-aging markers between the henagliflozin and placebo groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Jiaotong University School of Medicine, Xinhua Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Hongmei Zhang
• Email: spicygirlss@126.com
• Phone: +8613636347760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.