Recruiting
The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy
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…
ClinicalTrials.gov IDNCT06818851
PhasePHASE4
Enrollment64
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Age50 Years
SexALL
Conditions studied
Diabetes Mellitus, Type 2
About this 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.
Interventions
- Drug: Henggliflozin — 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.
- Other: Placebo — 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.
Primary outcomes
- Change from Baseline in the mean amplitude of glycemic excursions at 16 weeks (From enrollment to the end of treatment at 16 weeks)
Eligibility information
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.
Study locations
- Shanghai Jiaotong University School of Medicine, Xinhua Hospital, Shanghai, Shanghai Municipality 200092 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.