[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"latent-autoimmune-diabetes-in-adults-lada\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:latent-autoimmune-diabetes-in-adults-lada":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100628338","effects-of-cofrogliptin-on-beta-cell-function-in-lada-patients-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":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Latent Autoimmune Diabetes in Adults (LADA)",[29,30,31,32,33,34,35,36],"LADA","Adult-Onset Autoimmune Diabetes","DPP-4 inhibitor","Beta-cell Function","Randomized Controlled Trial","C-peptide","Vitamin D3","Cofrogliptin","NOT_YET_RECRUITING","2026-05-05",{"date":40,"type":41},"2026-05-08","ACTUAL",{"date":43,"type":21},"2026-05-15",{"date":45,"type":21},"2027-12-31",{"name":47,"class":48},"Second Xiangya Hospital of Central South University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":49},"100588459","hybrid-closed-loop-system-in-lada-patients-a-randomized-trial-100588459","NCT06941675","Hybrid Closed-Loop System in LADA Patients: A Randomized Trial","Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Latent Autoimmune Diabetes in Adults (LADA): An Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 18 and 70 years old.\n2. Meet the diagnostic criteria for LADA in the \"Chinese Expert Consensus on the Diagnosis and Treatment of Latent Autoimmune Diabetes in Adults (2021 Edition)\":\n\n   * The onset age of diabetes is ≥ 18 years old.\n   * Positive for islet autoantibodies or islet autoimmunity T cells.\n   * Do not rely on insulin therapy for at least 6 months after the diagnosis of diabetes.\n3. Patients are able to correctly use insulin pumps and CGM devices and have a certain learning ability and operational ability.\n4. Baseline HbA1c \\> 7.0% or HbA1c \\> 6.0% combined with hypoglycemia.\n5. Patients agree to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. The patient has been clearly diagnosed with type 2 diabetes or special types of diabetes.\n2. The patient has experienced acute diabetic complications within the past 1 month, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.\n3. The patient has severe symptoms of hypoglycemia intolerance.\n4. The patient has skin diseases such as rashes and prurigo, or abnormal coagulation function.\n5. The patient has diseases related to impaired glucose metabolism, such as uncontrolled hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.\n6. The patient has comorbid severe liver, kidney, gastrointestinal, hematological, brain, circulatory system diseases, etc.\n7. The patient has other severe chronic diseases (such as malignant tumors, end-stage organ failure, etc.).\n8. The patient has impaired consciousness or mental illness, lacks self-control, and cannot express clearly.\n9. Lactating women, pregnant women, or women who plan to become pregnant during the trial period.\n10. The patient is currently using or has used glucocorticoids or other drugs that interfere with glucose metabolism within 1 month before screening.\n11. The patient is allergic to the drugs involved in the clinical diagnosis and treatment plan.\n12. The patient is currently using other closed-loop systems.\n13. People who are not suitable for conventional insulin pump treatment and those with contraindications.\n14. The patient is known or suspected to have an insulin-allergic constitution and is allergic to adhesive tape, insulin pumps, or CGM devices.\n\nOther situations where the researcher deems the patient unfit to participate in the clinical trial.",{"count":58,"type":21},50,[24],"Based on the difficulties in blood glucose control among the Latent Autoimmune Diabetes in Adults (LADA) population and the deficiencies of previous studies, this research aims to conduct a clinical comparative study. The short-term blood glucose control effects of the closed-loop system and the combination of a conventional insulin pump and Continuous Glucose Monitoring (CGM) in hospitalized LADA patients will be evaluated to explore the clinical application value of these methods in LADA patients. Moreover, this study aims to provide a more precise and personalized blood glucose management plan for LADA patients. As a slowly progressive subtype of autoimmune type 1 diabetes mellitus (T1DM), LADA patients have significant differences in pathological characteristics, clinical needs, and treatment effects compared with classical T1DM patients. However, they also face huge challenges in blood glucose management. This study will focus on LADA patients for the first time, especially the group of hospitalized patients, to fill the gap in this field. Meanwhile, by introducing the cutting-edge closed-loop system technology, it will provide new ideas and solutions for the clinical blood glucose management of LADA patients. Through a comparative analysis of the short-term blood glucose control effects of the closed-loop system and the combination of a conventional insulin pump and CGM, this study aims to provide more precise and personalized treatment strategies for LADA patients and promote the further development of diabetes treatment technologies.",[27],"RECRUITING","2025-04-22",{"date":65,"type":41},"2025-04-24",{"date":67,"type":41},"2025-04-01",{"date":69,"type":21},"2027-08-31",{"name":71,"class":48},"Shanxi Bethune Hospital","Latent Autoimmune Diabetes in Adults LADA"]