[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441421":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":56,"locations":62,"responsibleParty":75,"collaborators":34,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":31,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":34,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":64,"whyStopped":34,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"EMS","INDUSTRY",[8,16,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Piemonte association","EXPERIMENTAL","The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:\n\n1 tablet Piemonte, oral;\n\n1 placebo tablet of empagliflozin, oral;\n\n1 placebo tablet of piglitazone, oral.",[13,14,15],"Drug: PIEMONTE","Other: PLACEBO EMPAGLIFLOZIN","Other: PLACEBO PIOGLITAZONE",{"label":17,"type":18,"description":19,"interventionNames":20},"Empagliflozin","ACTIVE_COMPARATOR","The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:\n\n1 placebo tablet of Piemonte, oral;\n\n1 tablet of empagliflozin, oral;\n\n1 placebo tablet of piglitazone, oral.",[21,22,15],"Other: PIEMONTE PLACEBO","Drug: EMPAGLIFLOZIN",{"label":24,"type":18,"description":25,"interventionNames":26},"Pioglitazone","The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:\n\n1 placebo tablet of Piemonte, oral;\n\n1 placebo tablet of empagliflozin, oral;\n\n1 tablet of piglitazone, oral.",[21,14,27],"Drug: PIOGLITAZONE",[29,35,40,44,48,52],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","PIEMONTE","Piemonte association 1 coated tablet once a day",[9],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"OTHER","PIEMONTE PLACEBO","Placebo of Piemonte association 1 coated tablet once a day",[17,24],{"type":30,"name":41,"description":42,"armGroupLabels":43,"otherNames":34},"EMPAGLIFLOZIN","Empagliflozin 25 mg 1 coated tablet once a day",[17],{"type":36,"name":45,"description":46,"armGroupLabels":47,"otherNames":34},"PLACEBO EMPAGLIFLOZIN","Placebo of empagliflozin 25 mg 1 coated tablet once a day",[9,24],{"type":30,"name":49,"description":50,"armGroupLabels":51,"otherNames":34},"PIOGLITAZONE","Pioglitazone 30 mg 1 tablet once a day",[24],{"type":36,"name":53,"description":54,"armGroupLabels":55,"otherNames":34},"PLACEBO PIOGLITAZONE","Placebo of pioglitazone 30 mg 1 tablet once a day",[17,9],[57],{"name":58,"role":59,"phone":60,"phoneExt":34,"email":61},"Arthur M Kummer, MD, PhD","CONTACT","+551938879851","pesquisa.clinica@ncfarma.com.br",[63],{"facility":5,"status":64,"city":65,"state":66,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":34},"RECRUITING","Hortolândia","São Paulo","Brazil","BR",{"type":70,"coordinates":71},"Point",[72,73],-47.22,-22.85833,{"lat":73,"lon":72},{"type":76,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100441421","phase-3-efficacy-and-safety-of-piemonte-association-in-the-treatment-of-type-ii-diabetes-mellitus-100441421",false,"NCT05028140","Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus","National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;\n* Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;\n* History of alcohol abuse or illicit drug use;\n* Participation in a clinical trial in the year prior to this study;\n* Pregnancy or risk of pregnacy and lactating participants;\n* Known hypersensitivity to any of the formula compounds;\n* Type 1 diabetes.","ALL","18 Years","85 Years",{"count":88,"type":89},480,"ESTIMATED","INTERVENTIONAL",[92],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus",[95],"Type II Diabetes",[97],"Type II diabetes mellitus","2025-12-01",{"date":100,"type":101},"2025-12-08","ACTUAL",{"date":103,"type":101},"2024-10-08",{"date":105,"type":89},"2027-09",{"name":5,"class":6},1]