[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597589":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":38,"interventions":52,"overallOfficials":27,"centralContacts":64,"locations":70,"responsibleParty":89,"collaborators":27,"id":91,"slug":27,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":27,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":27,"enrollmentInfo":99,"targetDuration":27,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":27,"overallStatus":73,"whyStopped":27,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Change in HbA1c","Change in HbA1c after 40 weeks of treatment.","from baseline to Week 40",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Proportion of subjects reaching HbA1\u003C7.0%","Proportion of subjects reaching HbA1\\\u003C7.0% after 40 weeks of treatment.",{"measure":18,"description":19,"timeFrame":12},"Proportion of subjects reaching HbA1≤6.5%","Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment.",{"measure":21,"description":22,"timeFrame":12},"Change in FPG","Change in FPG after 40 weeks of treatment.",{"measure":24,"description":25,"timeFrame":26},"Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score","Change from baseline in DTSQs after 40 weeks of treatment.","From baseline to Week 40",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":34},"TRIPLE",[35,36,37],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[39,44,47],{"label":40,"type":41,"description":27,"interventionNames":42},"Treatment group A: HRS9531-low dose","EXPERIMENTAL",[43],"Drug: HRS9531",{"label":45,"type":41,"description":27,"interventionNames":46},"Treatment group B: HRS9531-high dose",[43],{"label":48,"type":49,"description":27,"interventionNames":50},"Treatment group C","PLACEBO_COMPARATOR",[51],"Drug: Placebo",[53,58,61],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":27},"DRUG","HRS9531","HRS9531-low dose",[40],{"type":54,"name":55,"description":59,"armGroupLabels":60,"otherNames":27},"HRS9531-high dose",[45],{"type":54,"name":62,"description":62,"armGroupLabels":63,"otherNames":27},"Placebo",[48],[65],{"name":66,"role":67,"phone":68,"phoneExt":27,"email":69},"Hong Chen","CONTACT","+86-0518-82342973","hong.chen@hengrui.com",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Perking University Peoples' Hospital","RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":80,"coordinates":81},"Point",[82,83],116.39723,39.9075,{"lat":83,"lon":82},[86],{"name":87,"role":88,"phone":27,"phoneExt":27,"email":27},"Linong JI","PRINCIPAL_INVESTIGATOR",{"type":90,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100597589",false,"NCT07060456","Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin","A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.","Inclusion Criteria:\n\n1. Male or female, able and willing to provide a written informed consent\n2. Diagnosed with type 2 diabetes ≥ 90 days；\n3. On stable once-daily dose of basal insulin alone or in combination with metformin and\u002For SGLT2 inhibitor ≥ 90 days;\n4. HbA1c was 7.5%\\~11.0% (both inclusive);\n5. Body Mass Index (BMI) ≥22 kg\u002Fm2 at screening.\n\nExclusion Criteria:\n\n1. A history of type 1 diabetes, specific diabetes, or secondary diabetes;\n2. Have a history of severe hypoglycemia within t180 days prior to screening;\n3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；\n4. Have a history of malignancy within 5 years;\n5. Known or suspected allergy or intolerance to the investigational medicinal products or related products;\n6. Participation in any clinical trial of an approved or non-approved investigational product\u002Ftreatment within the last 90 days;\n7. Any conditions that the Investigator judges might not be suitable to participate in the trial.","ALL","18 Years",{"count":100,"type":101},300,"ESTIMATED","INTERVENTIONAL",[104],"PHASE3","The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and\u002For sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.",[107],"Type 2 Diabetes","2025-12-28",{"date":110,"type":111},"2026-01-02","ACTUAL",{"date":113,"type":111},"2025-07-25",{"date":115,"type":101},"2027-03",{"name":5,"class":6},1]