[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616563":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":358,"collaborators":360,"id":364,"slug":365,"hasResults":366,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":25,"eligibilityCriteria":370,"healthyVolunteers":366,"sex":371,"minAge":372,"maxAge":25,"enrollmentInfo":373,"targetDuration":25,"studyType":376,"phases":377,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"iGlarLixi group","EXPERIMENTAL","The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice.",[13],"Drug: iGlarLixi (insulin glargine\u002Flixisenatide)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care (SOC) group.","ACTIVE_COMPARATOR","The control drug treatment is standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs). Participants will receive standard of care with the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice.",[19],"Drug: standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","iGlarLixi (insulin glargine\u002Flixisenatide)",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Xiaoying li, 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University","Nanjing","Jiangsu","210003",{"type":45,"coordinates":186},[187,188],118.77778,32.06167,{"lat":188,"lon":187},[191],{"name":192,"role":32,"phone":193,"phoneExt":25,"email":194},"Yibing Lu","+86 25 58509900","luyibing2004@126.com",{"facility":196,"status":38,"city":197,"state":198,"zip":199,"country":42,"countryCode":43,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"The Second Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330006",{"type":45,"coordinates":201},[202,203],115.85306,28.68396,{"lat":203,"lon":202},[206],{"name":207,"role":32,"phone":208,"phoneExt":25,"email":209},"Jianping Liu","+86 791 86120120","liujpnfm@163.com",{"facility":211,"status":38,"city":212,"state":213,"zip":214,"country":42,"countryCode":43,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"The First Clinical Hospital of Jilin Academy of Chinese Medicine 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20302000","Chinallu@163.com",{"facility":273,"status":38,"city":227,"state":228,"zip":274,"country":42,"countryCode":43,"cosmosGeoPoint":275,"geoPoint":277,"contacts":278},"Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine","200336",{"type":45,"coordinates":276},[232,233],{"lat":233,"lon":232},[279],{"name":280,"role":32,"phone":281,"phoneExt":25,"email":25},"Shan Huang","+86 21 52039999",{"facility":283,"status":38,"city":227,"state":228,"zip":284,"country":42,"countryCode":43,"cosmosGeoPoint":285,"geoPoint":287,"contacts":288},"Minhang Hospital, Fudan University \u002F Central Hospital of Minhang District, Shanghai","201199",{"type":45,"coordinates":286},[232,233],{"lat":233,"lon":232},[289],{"name":290,"role":32,"phone":291,"phoneExt":25,"email":292},"Yuping Song","+86 21 64923400","15901838098@163.com",{"facility":294,"status":38,"city":227,"state":228,"zip":295,"country":42,"countryCode":43,"cosmosGeoPoint":296,"geoPoint":298,"contacts":299},"Shanghai Qingpu District Central Hospital \u002F Qingpu Branch of Zhongshan Hospital, Fudan University","201700",{"type":45,"coordinates":297},[232,233],{"lat":233,"lon":232},[300],{"name":301,"role":32,"phone":302,"phoneExt":25,"email":303},"Min Zhang","+86 21 67009999","18116016187@163.com",{"facility":305,"status":38,"city":306,"state":307,"zip":308,"country":42,"countryCode":43,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Zhejiang Provincial People's Hospital","Hangzhou","Zhejiang","310014",{"type":45,"coordinates":310},[311,312],120.16142,30.29365,{"lat":312,"lon":311},[315],{"name":316,"role":32,"phone":317,"phoneExt":25,"email":318},"Xiaohong Wu","+86 571 87666666","drxhwu@163.com",{"facility":320,"status":38,"city":321,"state":307,"zip":322,"country":42,"countryCode":43,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"Jiaxing First Hospital","Jiaxing","314001",{"type":45,"coordinates":324},[325,326],120.75,30.7522,{"lat":326,"lon":325},[329],{"name":330,"role":32,"phone":331,"phoneExt":25,"email":332},"Qiang Zhou","+86 573 82519999","zhouqiang8004@163.com",{"facility":334,"status":38,"city":335,"state":307,"zip":336,"country":42,"countryCode":43,"cosmosGeoPoint":337,"geoPoint":341,"contacts":342},"Ningbo No. 2 Hospital","Ningbo","315010",{"type":45,"coordinates":338},[339,340],121.54945,29.87819,{"lat":340,"lon":339},[343],{"name":344,"role":32,"phone":345,"phoneExt":25,"email":346},"Mingchen Zhang","+86 574 83870999","Zhangmc1015@163.com",{"facility":348,"status":38,"city":335,"state":307,"zip":349,"country":42,"countryCode":43,"cosmosGeoPoint":350,"geoPoint":352,"contacts":353},"Ningbo Medical Center Lihuili Hospital","315040",{"type":45,"coordinates":351},[339,340],{"lat":340,"lon":339},[354],{"name":355,"role":32,"phone":356,"phoneExt":25,"email":357},"Lingling Fang","+86 574 87018701","cxyangy@126.com",{"type":359,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[361],{"name":362,"class":363},"Sanofi (China) Investment Co., Ltd","UNKNOWN","100616563","phase-4-efficacy-and-safety-of-iglarlixi-versus-standard-of-care-in-a-real-world-adult-china-population-with-uncontrolled-type-2-diabetes-on-oral-agents-100616563",false,"NCT07307235","Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents","Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents-a Pragmatic Randomized Controlled Trial","Inclusion Criteria:\n\n1. Participant must be at least 18 of age inclusive, at the time of signing the informed consent.\n2. Type 2 diabetes mellitus diagnosis.\n3. Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs.\n4. HbA1c 7.5-11%\n5. Further intensification with an additional antidiabetic injectable medication is indicated to achieve glycaemic target at the discretion of the study physician according to approval labelling.\n\nParticipants who have signed informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Diagnosed with T1DM\n2. BMI \\\u003C20 kg\u002Fm2 or BMI ≥40 kg\u002Fm2\n3. Treatment with more than 3 oral antidiabetic medications, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary\u002Femergency use of insulin is allowed, as is prior insulin treatment for gestational diabetes.\n4. Contraindications to iGlarLixi according to the China NMPA approved label.\n5. Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.\n6. Participants who involved in other clinical trial within 3 months prior to the time of screening visit.\n7. Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2\n8. Pregnant or breast-feeding woman.\n9. Woman of childbearing potential not protected by highly effective contraceptive method of birth control and\u002For who is unwilling or unable to be tested for pregnancy.\n10. Conditions\u002Fsituations such as:\n\nParticipant with short life expectancy. Participant with conditions\u002Fconcomitant diseases making him\u002Fher not evaluable for the primary efficacy endpoint (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to screening).\n\nParticipant with conditions\u002Fconcomitant diseases precluding his\u002Fher safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period).\n\nUncooperative or any condition that could make the participant potentially non-compliant to the study procedures.","ALL","18 Years",{"count":374,"type":375},1316,"ESTIMATED","INTERVENTIONAL",[378],"PHASE4","This study is a prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT). It will compare the efficacy and safety of iGlarLixi versus standard of care in adult T2DM patients with poor glycemic control, who are using 1 to 3 OADs in a real-world clinical practice setting. A total of 1,316 subjects from approximately 40 research centers in China will be randomly assigned in a 1:1 ratio to one of the following treatment groups: Group 1: iGlarLixi for blood glucose control; and Group 2: Standard of care for diabetes (basal insulin or premixed insulin, excluding any GLP-1RA-containing drugs). Considering the substantial difference in intervention methods between the two groups, the study is designed as non-blinded with an open-label approach.",[381],"Type 2 Diabetes",[383,384,385],"diabetes","iGlarLixi","RCT","2026-07-06",{"date":388,"type":389},"2026-07-07","ACTUAL",{"date":391,"type":389},"2025-12-13",{"date":393,"type":375},"2027-12-30",{"name":5,"class":6},24]