[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413982":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":52,"locations":58,"responsibleParty":71,"collaborators":30,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":30,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":30,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":60,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"EMS","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"MADALENA","EXPERIMENTAL","The study is triple-dummy. The patient must take 3 tablets once a day, as follows:\n\n1 tablet Madalena association, oral;\n\n1 tablet empagliflozin + linagliptin association placebo, oral;\n\n1 tablet metformin placebo, oral.",[13,14,15],"Drug: MADALENA ASSOCIATION","Other: METFORMIN PLACEBO","Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO",{"label":17,"type":18,"description":19,"interventionNames":20},"Metformin + empagliflozin + linagliptin","ACTIVE_COMPARATOR","The patient must take 3 tablets once a day, as follows:\n\n1 tablet Madalena association placebo, oral;\n\n1 tablet empagliflozin + linagliptin association, oral;\n\n1 tablet metformin, oral.",[21,22,23],"Drug: METFORMIN","Drug: EMPAGLIFLOZIN + LINAGLIPTIN","Other: MADALENA ASSOCIATION PLACEBO",[25,31,35,39,44,48],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","MADALENA ASSOCIATION","Madalena association coated tablet.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"METFORMIN","Metformin 1000 mg extended-release tablet.",[17],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"EMPAGLIFLOZIN + LINAGLIPTIN","Empagliflozin 10 mg + linagliptin 5 mg coated tablet.",[17],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":30},"OTHER","MADALENA ASSOCIATION PLACEBO","Madalena association placebo tablet.",[17],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":30},"METFORMIN PLACEBO","Metformin placebo tablet.",[9],{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":30},"EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO","Empagliflozin + linagliptin placebo tablet.",[9],[53],{"name":54,"role":55,"phone":56,"phoneExt":30,"email":57},"Monalisa FB Oliveira, MD","CONTACT","+551938879851","pesquisa.clinica@ncfarma.com.br",[59],{"facility":5,"status":60,"city":61,"state":62,"zip":30,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":30},"RECRUITING","Hortolândia","São Paulo","Brazil","BR",{"type":66,"coordinates":67},"Point",[68,69],-47.22,-22.85833,{"lat":69,"lon":68},{"type":72,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100413982","phase-3-efficacy-and-safety-of-madalena-association-in-the-treatment-of-type-ii-diabetes-mellitus-100413982",false,"NCT04670666","Efficacy and Safety of Madalena 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 Madalena 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 informed consent forms;\n* Participants with 18 years of age or greater;\n* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and at least 3 months with two anti-hyperglycemic agents (dual therapy);\n* HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \\> 100 mg\u002FdL at the screening visit;\n* BMI (body mass index) \\> 19 Kg\u002Fm2 and ≤ 45 Kg\u002Fm2.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research 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 pregnancy and lactating patients;\n* Known hypersensitivity to the formula components used during the clinical trial;\n* Type 1 diabetes mellitus;\n* Fasting blood glucose \\> 300 mg\u002FdL;\n* Risk factors for volume depletion;\n* Impaired renal function and end-stage renal disease;\n* Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;\n* Impaired hepatic function;\n* Medical history of pancreatic diseases that may suggest insulin deficiency;\n* Bariatric surgery in the last two years and\u002F or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;\n* Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;\n* Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;\n* Current medical history of cancer and\u002F or cancer treatment in the last 5 years;\n* Medical history of metabolic acidosis and\u002For using drugs that may cause lactic acidosis;\n* Medical history of blood dyscrasia or any other hemolytic disorders;\n* Participants using sulfonylureas and\u002For insulin therapy;\n* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.","ALL","18 Years",{"count":83,"type":84},270,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.",[90],"Type 2 Diabetes Mellitus",[90],"2025-12-01",{"date":94,"type":95},"2025-12-08","ACTUAL",{"date":97,"type":95},"2024-11-18",{"date":99,"type":84},"2027-06",{"name":5,"class":6},1]