[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630394":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":11,"responsibleParty":33,"collaborators":11,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":11,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":11,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"QLG1091","EXPERIMENTAL",null,[13],"Drug: QLG1091",{"label":15,"type":16,"description":11,"interventionNames":17},"Rybelsus","ACTIVE_COMPARATOR",[18],"Drug: Rybelsus",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Oral administration once-daily.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Oral administration once-daily",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Fangyi Wang, Bachelor","CONTACT","+86-18266419923","fangyi.wang@qilu-pharma.com",{"type":34,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100630394","phase-3-efficacy-and-safety-of-qlg1091-vs-rybelsus-as-add-on-to-metformin-in-subjects-with-type-2-diabetes-100630394",false,"NCT07487103","Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes","A Multicenter, Randomized, Open-label, Parallel-group, Active-controlled Clinical Trial to Evaluate Efficacy and Safety of QLG1091 Versus Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes","Inclusion Criteria:\n\n1. Female or male，age 18 to 75.\n2. Body mass index (BMI) ≥ 22 kg\u002Fm² and ≤ 35 kg\u002Fm² at screening.\n3. HbA1c of 7.0-10.5 %.\n4. Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.\n5. Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose≥1000 mg\u002Fday) at least 90 days prior to the day of screening.\n\nExclusion Criteria:\n\n1. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.\n2. History of pancreatitis (acute or chronic).\n3. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).\n4. Subjects presently classified as being in New York Heart Association Class IV.\n5. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.\n6. Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL\u002Fmin\u002F1.73 m\\\\\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).","ALL","18 Years","75 Years",{"count":46,"type":47},478,"ESTIMATED","INTERVENTIONAL",[50],"PHASE3","This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.",[53],"Type 2 Diabetes","NOT_YET_RECRUITING","2026-04-22",{"date":57,"type":58},"2026-04-28","ACTUAL",{"date":60,"type":47},"2026-05-01",{"date":62,"type":47},"2027-05",{"name":5,"class":6}]