[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579019":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Henggliflozin 10mg per day for 16 weeks",[13],"Drug: Henggliflozin",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","Placebo 10mg per day for 16 weeks",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32],{"name":33,"affiliation":5,"role":34},"Qing Su","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Hongmei Zhang","CONTACT","+8613636347760","spicygirlss@126.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Shanghai Jiaotong University School of Medicine, Xinhua Hospital","RECRUITING","Shanghai","Shanghai Municipality","200092","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":39,"phoneExt":26,"email":40},"Hongmei Zhang, PHD",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[62],{"name":63,"class":64},"Jiangsu Hengrui Pharmaceutical Co., Ltd.","INDUSTRY","100579019","phase-4-the-effects-of-henagliflozin-on-glucose-fluctuation-and-immunosenescence-in-type-2-diabetes-patients-on-insulin-therapy-100579019",false,"NCT06818851","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)","HOLIDYA","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months based on the 1999 WHO criteria.\n\n  * Age between 50 and 70 years at the time of signing the informed consent form (inclusive).\n  * Poor glycemic control despite treatment with basal insulin or insulin degludec\u002Faspart (with or without oral antidiabetic drugs) within the 3 months prior to screening.\n  * HbA1c level above 8%.\n  * BMI ≥ 20 kg\u002Fm².\n  * C-peptide levels within the normal reference range.\n  * Able to maintain stable dietary and exercise habits during the study.\n  * Capable of understanding the study procedures and methods, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients considered by the investigator to have potential allergies to the components of the study drug or drugs of the same class.\n\n  * Use of SGLT2 inhibitors or GLP-1 receptor agonists within 3 months prior to screening.\n  * Adjustments to antidiabetic treatment regimens within 3 months prior to screening.\n  * 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.\n  * Volume depletion.\n  * Chronic (\\>2 weeks) systemic glucocorticoid therapy or use of glucocorticoids within 4 weeks prior to screening (except for topical, intraocular, intranasal, or inhaled administration).\n  * Pregnancy, lactation, or plans for pregnancy within the next 6 months.\n  * Persistently elevated serum transaminase levels (more than 3 times the upper limit of normal).\n  * Renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 45 mL\u002Fmin\u002F1.73 m²).\n  * History of malignant tumors.\n  * Presence of acute complications (e.g., ketoacidosis, diabetic ketoacidosis, lactic acidosis, or hyperosmolar coma).\n  * Systemic autoimmune diseases, such as systemic lupus erythematosus.\n  * Clinically significant urinary tract infections and\u002For genital infections, or a history of recurrent urinary tract and\u002For genital infections.\n  * Any other factors deemed by the investigator to potentially affect the efficacy or safety evaluation of the study.\n  * Participation in other clinical trials and receipt of investigational drugs within 3 months prior to screening.","ALL","50 Years","70 Years",{"count":77,"type":78},64,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","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.\n\nThe main questions it aims to answer are:\n\nDoes 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.\n\nParticipants will:\n\nTake 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.",[84],"Diabetes Mellitus, Type 2",[86,87,88],"Sodium-glucose cotransporter 2","glycemic variability","immunosenescence","2025-07-16",{"date":91,"type":92},"2025-07-20","ACTUAL",{"date":94,"type":92},"2025-07-14",{"date":96,"type":78},"2028-03-30",{"name":5,"class":6},1]