[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591148":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","ACTIVE_COMPARATOR","active drug or placebo in a cross over randomised sequence",[13],"Drug: Dorzagliatin",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","placebo in a cross over randomised sequence",[19],"Drug: matched placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dorzagliatin","Dorzagliatin 50mg bd",[9],null,{"type":22,"name":28,"description":28,"armGroupLabels":29,"otherNames":26},"matched placebo",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Elaine Chow, MD","CONTACT","+852 35051641","e.chow@cuhk.edu.hk",[37],{"facility":38,"status":39,"city":40,"state":26,"zip":26,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"3M, Diabetes and Endocrine Research Center","RECRUITING","Hong Kong","HK",{"type":43,"coordinates":44},"Point",[45,46],114.17469,22.27832,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":26,"email":52},"Michelle Luk","+852 35052648","michelleluk@cuhk.edu.hk",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Elaine Chow","Associate Professor","100591148","phase-2-glucokinase-activator-in-monogenic-diabetes-100591148",false,"NCT06976658","Glucokinase Activator in Monogenic Diabetes","Evaluating a Novel, Allosteric Glucokinase Activator in Monogenic Diabetes Secondary to Inactivating Glucokinase Mutations: a Randomised, Cross-over Trial","RESENSE","Inclusion Criteria:\n\n1. Age ≥18 and \\\u003C75 years\n2. body mass index (BMI) \\>18 and \\\u003C30 kg\u002Fm2\n3. fasting plasma glucose \\>5.6 mmol\u002FL at screening\n4. Participants with GCK-MODY had and are heterozygous carriers of a pathogenic or likely pathogenic GCK mutation at screening based on guidelines published by the American College of Medical Genetics and Genomics (ACMG), Association for Clinical Genomic Science (ACGS) and the ClinGen Monogenic Diabetes Expert Panel (MDEP) .\n\nExclusion Criteria:\n\n1. Body weight \\\u003C45kg at screening\n2. Current or planning pregnancy or lactating\n3. troke or cardiovascular disease within 6 months of recruitment\n4. severe renal dysfunction (estimated glomerular filtration rate \\\u003C30mL\u002Fmin\u002F1.73m2 or renal replacement therapy)\n5. severe hepatic dysfunction (aspartate transaminase and\u002For alanine transaminase \\> 3 times upper limit of normal)\n6. history of drug abuse or excessive alcohol intake\n7. severe hypoglycemia within 6 months prior to screening\n8. anaemia with Hb \\\u003C10 g\u002FdL at screening\n9. excessive blood loss \\>300mL within 1 month of screening\n10. use of strong or moderate CYP3A4 inhibitors or inducers\n11. use of sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 6 weeks prior to randomisation\n12. use of long-term high-dose corticosteroids at randomisation\n13. serious concurrent infections at time of screening","ALL","18 Years","74 Years",{"count":69,"type":70},44,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial",[76,77],"Diabetes Mellitus","Monogenic Diabetes",[79,80],"GCK-MODY","glucokinase activator","2026-04-25",{"date":83,"type":84},"2026-04-30","ACTUAL",{"date":86,"type":84},"2025-04-30",{"date":88,"type":70},"2026-12-31",{"name":5,"class":6},1]