RecruitingPhase 4NCT06818851

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

The Effects of Henagliflozin on glucOse fLuctuation and Immunosenescence in Type 2 Diabetes pAtients on Insulin therapY: a Multicenter, Randomized, Double-blind, Placebo-controlled Study (the HOLIDYA Study)

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

64 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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

Min Age: 50 YearsMax Age: 70 Years

Inclusion Criteria8

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 Criteria15

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.

Interventions

DRUGHenggliflozin

Upon 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.

OTHERPlacebo

Upon 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.