[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608236":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":10,"locations":27,"responsibleParty":82,"collaborators":10,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":10,"enrollmentInfo":96,"targetDuration":10,"studyType":99,"phases":10,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":108,"whyStopped":10,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Cofrogliptin cohort",null,[12],"Drug: Cofrogliptin add to insulin",{"label":14,"type":10,"description":10,"interventionNames":15},"Linagliptin cohort",[16],"Drug: Linagliptin add to insulin",[18,23],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","Cofrogliptin add to insulin","Patients will be treated with commercially available cofrogliptin according to routine clinical practice at the discretion of the treating physician.",[9],{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Linagliptin add to insulin","Patients will be treated with commercially available linagliptin according to routine clinical practice at the discretion of the treating physician.",[14],[28,40,48,56,61,69,74],{"facility":29,"status":10,"city":30,"state":31,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University","Hangzhou","Zhejiang","China","CN",{"type":35,"coordinates":36},"Point",[37,38],120.16142,30.29365,{"lat":38,"lon":37},{"facility":41,"status":10,"city":42,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":43,"geoPoint":47,"contacts":10},"Affiliated Hospital of Hebei University","Baoding",{"type":35,"coordinates":44},[45,46],115.46246,38.87288,{"lat":46,"lon":45},{"facility":49,"status":10,"city":50,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":51,"geoPoint":55,"contacts":10},"Beijing Luhe Hospital Affiliated to Capital Medical University","Beijing",{"type":35,"coordinates":52},[53,54],116.39723,39.9075,{"lat":54,"lon":53},{"facility":57,"status":10,"city":50,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":58,"geoPoint":60,"contacts":10},"the First Medical Center of Chinese PLA General Hospital",{"type":35,"coordinates":59},[53,54],{"lat":54,"lon":53},{"facility":62,"status":10,"city":63,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University","Shanghai",{"type":35,"coordinates":65},[66,67],121.45806,31.22222,{"lat":67,"lon":66},{"facility":70,"status":10,"city":63,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":71,"geoPoint":73,"contacts":10},"Shanghai Changzheng Hospital",{"type":35,"coordinates":72},[66,67],{"lat":67,"lon":66},{"facility":75,"status":10,"city":76,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":77,"geoPoint":81,"contacts":10},"Xi'an International Medical Center Hospital","Xi'an",{"type":35,"coordinates":78},[79,80],108.92861,34.25833,{"lat":80,"lon":79},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Yanbing Li","First Affiliated Hospital, Sun Yat-Sen University","100608236","cofrogliptin-and-linagliptin-as-add-on-therapy-to-insulin-in-type-2-diabetes-100608236",false,"NCT07198932","Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes","Effectiveness and Safety of Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Chinese Adults With Type 2 Diabetes Mellitus: a Multicenter, Prospective Real-world Study (COLOR-REAL)","COLOR-REAL","Inclusion Criteria:\n\n1. Sign the informed consent form.\n2. Aged ≥18 years.\n3. Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria).\n4. Recently tested HbA1c 7%-9% and FPG ≤11 mmol\u002FL, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total.\n5. Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent.\n\nExclusion Criteria:\n\n1. Allergic to the study drug.\n2. Diagnosed with type 1 diabetes.\n3. Unable to comply with study-specific procedures.\n4. Current or planned pregnant, or currently breastfeeding.\n5. With any other situation judged by the investigator, that is unsuitable for participation in this trial.","ALL","18 Years",{"count":97,"type":98},594,"ESTIMATED","OBSERVATIONAL","This study is a multicenter, prospective, non-interventional real-world study to evaluate the clinical outcomes of biweekly cofrogliptin versus daily linagliptin as an add-on therapy in Chinese adult T2D patients.",[102],"Type 2 Diabetes",[104,105,106,107],"real-world study","cofrogliptin","DPP-4i","insulin","NOT_YET_RECRUITING","2025-09-28",{"date":111,"type":112},"2025-09-30","ACTUAL",{"date":114,"type":98},"2025-10-01",{"date":116,"type":98},"2027-12-31",{"name":84,"class":6},7]