Henagliflozin Added to Insulin for Blood Sugar Swings in Type 2 Diabetes
Tests henagliflozin against a placebo in adults with type 2 diabetes taking insulin.
Plain-language title generated from the registry record
Registry title: The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 70 years old?
Source: NCT06818851, who can take part
Where in China
- Shanghai Jiaotong University School of Medicine, Xinhua HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Trial code
- NCT06818851
- Record updated
- 20 July 2025
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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.