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

Plain Language Summary

Simplified for easier understanding

This study examines whether a diabetes drug called henagliflozin (an SGLT2 inhibitor) can improve blood sugar control and slow immune aging in older adults with type 2 diabetes who are already using insulin but still have poor blood sugar control. **You may be eligible if...** - You have had type 2 diabetes for at least 6 months - You are between 50 and 70 years old - Your HbA1c (long-term blood sugar measure) is above 8% - You are on basal insulin (with or without other diabetes tablets) but your blood sugar is still not well controlled - Your BMI is 20 or above and your insulin-producing cells are still functioning **You may NOT be eligible if...** - You have serious kidney, liver, or heart conditions - You are pregnant or planning pregnancy - You have conditions that your doctor determines make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.