NCT06818851RecruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 20 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- 14 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Type 2 diabetes
- NCT number
- NCT06818851
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 64
- From 14 Jul 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Jiaotong University School of Medicine, Xinhua Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.