[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628338":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":46,"locations":54,"responsibleParty":70,"collaborators":28,"id":73,"slug":28,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":28,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":98,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Cofrogliptin + Vitamin D3 + Background Therapy","EXPERIMENTAL","Participants will receive Cofrogliptin (10 mg orally every 2 weeks) and Vitamin D3 (2000 IU orally once daily), in addition to background therapy consisting of metformin (with or without insulin), over a period of 52 weeks.",[13,14,15,16],"Drug: Cofrogliptin","Drug: Vitamin D3","Drug: Metformin","Drug: Insulin",{"label":18,"type":19,"description":20,"interventionNames":21},"Vitamin D3 + Background Therapy","ACTIVE_COMPARATOR","Participants will receive Vitamin D3 (2000 IU orally once daily), in addition to background therapy consisting of metformin (with or without insulin), for a total duration of 52 weeks.",[14,15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Cofrogliptin","5 mg\u002Ftablet, oral; 2 tablets (10 mg) once every 2 weeks. Administered from randomization through Week 52.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Vitamin D3","400 IU\u002Fcapsule, oral; 5 capsules (2000 IU) once daily. Administered from randomization through Week 52.",[9,18],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Metformin","Background therapy. Oral; typical daily dose 1.5 g, adjustable from 1.0 to 1.7 g\u002Fday per investigator judgment.",[9,18],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Insulin","Background therapy, as needed. Subcutaneous; individualized daily dose per investigator judgment.",[9,18],[42],{"name":43,"affiliation":44,"role":45},"Zhiguang Zhou, MD,PhD","The Second Xiangya Hospital, Central South University","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":28,"email":50},"CONTACT","+8673185292154","zhouzhiguang@csu.edu.cn",{"name":52,"role":48,"phone":28,"phoneExt":28,"email":53},"Chuqing Cao, PhD","csuccq@163.com",[55],{"facility":44,"status":28,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Changsha","Hunan","410000","China","CN",{"type":62,"coordinates":63},"Point",[64,65],112.97087,28.19874,{"lat":65,"lon":64},[68,69],{"name":43,"role":48,"phone":49,"phoneExt":28,"email":50},{"name":52,"role":48,"phone":28,"phoneExt":28,"email":53},{"type":45,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Zhiguang Zhou","Director, National Clinical Research Center for Endocrine and Metabolic Diseases","100628338",false,"NCT07460336","Effects of Cofrogliptin on Beta-Cell Function in LADA Patients","Key Effects of Cofrogliptin on Beta-cell Function in Adults With Latent Autoimmune Diabetes (LADA): A Single-Center, Randomized, Controlled Trial - KOLA Study","Inclusion Criteria:\n\n* 1\\. Voluntarily signed informed consent.\n* 2\\. Age 18 to 70 years, inclusive.\n* 3\\. Diagnosed with LADA, defined as meeting all of the following:\n* (1) Meets 1999 WHO criteria for diabetes mellitus.\n* (2) Age at diagnosis of diabetes ≥ 18 years.\n* (3) Positive for at least one islet autoantibody (GADA, IA-2A, or ZnT8A).\n* (4) Did not require continuous insulin therapy for at least 6 months after diagnosis.\n* 4\\. Stimulated C-peptide ≥ 200 pmol\u002FL.\n* 5\\. Glycated Hemoglobin (HbA1c) ≤ 9.0%.\n* 6\\. For women of childbearing potential, must agree to use a highly effective method of contraception throughout the study.\n\nExclusion Criteria:\n\n* 1\\. Pregnant, breastfeeding, or planning to become pregnant during the study.\n* 2\\. Gestational diabetes or other specific types of diabetes.\n* 3\\. Known hypersensitivity to Cogliptin, Vitamin D3, or their excipients.\n* 4\\. Use of DPP-4 inhibitors, GLP-1 receptor agonists, or thiazolidinediones (TZDs) within 8 weeks prior to randomization.\n* 5\\. Hypercalcemia (serum calcium above the upper limit of the normal range).\n* 6\\. Systemic corticosteroid therapy (oral or IV) for more than 7 consecutive days within 6 months prior to screening.\n* 7\\. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN), or total bilirubin \\> 2 times ULN.\n* 8\\. Estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m².\n* 9\\. History of acute diabetic complications such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state.\n* 10\\. History of pancreatitis or pancreatic surgery.\n* 11\\. New York Heart Association (NYHA) class III or IV congestive heart failure, or known left ventricular ejection fraction (LVEF) \\\u003C 40%.\n* 12\\. History of malignancy.\n* 13\\. Severe psychiatric illness.\n* 14\\. History of alcohol or illicit drug dependence.\n* 15\\. Any other severe systemic disease that the investigator deems unsuitable for enrollment.","ALL","18 Years","70 Years",{"count":83,"type":84},84,"ESTIMATED","INTERVENTIONAL",[87],"NA","This single-center, randomized, open-label, controlled study aims to evaluate the effect of cofrogliptin on pancreatic β-cell function in adults with latent autoimmune diabetes in adults (LADA). Following a screening period of up to 6 weeks, 84 eligible participants will be randomized in a 1:1 ratio via a sealed-envelope method, stratified by baseline GADA titer (≥0.3 vs \\\u003C0.3). Participants will be assigned to one of two treatment arms: (1) metformin (with or without insulin) plus vitamin D3, or (2) metformin (with or without insulin) plus vitamin D3 and cofrogliptin. Cofrogliptin will be administered orally at a dose of 10 mg once every 2 weeks, and vitamin D3 at 2000 IU once daily, for a total treatment duration of 52 weeks. Study visits are planned at baseline and at Weeks 12, 26, 38, and 52, during which mixed-meal tolerance tests (MMTT) and other protocol-specified assessments will be conducted.",[90],"Latent Autoimmune Diabetes in Adults (LADA)",[92,93,94,95,96,97,30,25],"LADA","Adult-Onset Autoimmune Diabetes","DPP-4 inhibitor","Beta-cell Function","Randomized Controlled Trial","C-peptide","NOT_YET_RECRUITING","2026-05-05",{"date":101,"type":102},"2026-05-08","ACTUAL",{"date":104,"type":84},"2026-05-15",{"date":106,"type":84},"2027-12-31",{"name":5,"class":6},1]