[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413982":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":11,"studyPopulation":11,"armGroups":26,"interventions":43,"overallOfficials":11,"centralContacts":70,"locations":76,"responsibleParty":89,"collaborators":11,"id":91,"slug":11,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":11,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":11,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"EMS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in glycated hemoglobin (HbA1c) levels.",null,"120 days",[14],{"measure":15,"description":11,"timeFrame":16},"Incidence and severity of adverse events recorded during the study.","150 days",{"allocation":18,"interventionModel":19,"interventionModelDescription":11,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":11,"whoMasked":23},"DOUBLE",[24,25],"PARTICIPANT","INVESTIGATOR",[27,35],{"label":28,"type":29,"description":30,"interventionNames":31},"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.",[32,33,34],"Drug: MADALENA ASSOCIATION","Other: METFORMIN PLACEBO","Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO",{"label":36,"type":37,"description":38,"interventionNames":39},"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.",[40,41,42],"Drug: METFORMIN","Drug: EMPAGLIFLOZIN + LINAGLIPTIN","Other: MADALENA ASSOCIATION PLACEBO",[44,49,53,57,62,66],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"DRUG","MADALENA ASSOCIATION","Madalena association coated tablet.",[28],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"METFORMIN","Metformin 1000 mg extended-release tablet.",[36],{"type":45,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"EMPAGLIFLOZIN + LINAGLIPTIN","Empagliflozin 10 mg + linagliptin 5 mg coated tablet.",[36],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"OTHER","MADALENA ASSOCIATION PLACEBO","Madalena association placebo tablet.",[36],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":11},"METFORMIN PLACEBO","Metformin placebo tablet.",[28],{"type":58,"name":67,"description":68,"armGroupLabels":69,"otherNames":11},"EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO","Empagliflozin + linagliptin placebo tablet.",[28],[71],{"name":72,"role":73,"phone":74,"phoneExt":11,"email":75},"Monalisa FB Oliveira, MD","CONTACT","+551938879851","pesquisa.clinica@ncfarma.com.br",[77],{"facility":5,"status":78,"city":79,"state":80,"zip":11,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":11},"RECRUITING","Hortolândia","São Paulo","Brazil","BR",{"type":84,"coordinates":85},"Point",[86,87],-47.22,-22.85833,{"lat":87,"lon":86},{"type":90,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":100,"type":101},270,"ESTIMATED","INTERVENTIONAL",[104],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.",[107],"Type 2 Diabetes Mellitus",[107],"2025-12-01",{"date":111,"type":112},"2025-12-08","ACTUAL",{"date":114,"type":112},"2024-11-18",{"date":116,"type":101},"2027-06",{"name":5,"class":6},1]