Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-03 @ 6:11 AM
Study NCT ID:
NCT04670666
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2020-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000069476', 'term': 'Linagliptin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in glycated hemoglobin (HbA1c) levels.', 'timeFrame': '120 days'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events recorded during the study.', 'timeFrame': '150 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/dL at the screening visit;\n* BMI (body mass index) \\> 19 Kg/m2 and ≤ 45 Kg/m2.\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/dL;\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/ 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/ or cancer treatment in the last 5 years;\n* Medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis;\n* Medical history of blood dyscrasia or any other hemolytic disorders;\n* Participants using sulfonylureas and/or insulin therapy;\n* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months."}, 'identificationModule': {'nctId': 'NCT04670666', 'briefTitle': 'Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'EMS1419 - MADALENA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MADALENA', 'description': '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.', 'interventionNames': ['Drug: MADALENA ASSOCIATION', 'Other: METFORMIN PLACEBO', 'Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin + empagliflozin + linagliptin', 'description': '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.', 'interventionNames': ['Drug: METFORMIN', 'Drug: EMPAGLIFLOZIN + LINAGLIPTIN', 'Other: MADALENA ASSOCIATION PLACEBO']}], 'interventions': [{'name': 'MADALENA ASSOCIATION', 'type': 'DRUG', 'description': 'Madalena association coated tablet.', 'armGroupLabels': ['MADALENA']}, {'name': 'METFORMIN', 'type': 'DRUG', 'description': 'Metformin 1000 mg extended-release tablet.', 'armGroupLabels': ['Metformin + empagliflozin + linagliptin']}, {'name': 'EMPAGLIFLOZIN + LINAGLIPTIN', 'type': 'DRUG', 'description': 'Empagliflozin 10 mg + linagliptin 5 mg coated tablet.', 'armGroupLabels': ['Metformin + empagliflozin + linagliptin']}, {'name': 'MADALENA ASSOCIATION PLACEBO', 'type': 'OTHER', 'description': 'Madalena association placebo tablet.', 'armGroupLabels': ['Metformin + empagliflozin + linagliptin']}, {'name': 'METFORMIN PLACEBO', 'type': 'OTHER', 'description': 'Metformin placebo tablet.', 'armGroupLabels': ['MADALENA']}, {'name': 'EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO', 'type': 'OTHER', 'description': 'Empagliflozin + linagliptin placebo tablet.', 'armGroupLabels': ['MADALENA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hortolândia', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'EMS', 'geoPoint': {'lat': -22.85833, 'lon': -47.22}}], 'centralContacts': [{'name': 'Monalisa FB Oliveira, MD', 'role': 'CONTACT', 'email': 'pesquisa.clinica@ncfarma.com.br', 'phone': '+551938879851'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}