Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT01429818
Status:
COMPLETED
Last Update Posted:
2011-09-07
First Post:
2011-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'C057619', 'term': 'glimepiride'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-06', 'studyFirstSubmitDate': '2011-09-05', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EDVI', 'timeFrame': '8 weeks', 'description': 'endothelial-dependent vasodilation index'}, {'measure': 'MFR', 'timeFrame': '8 weeks', 'description': 'myocardial flow reserve'}, {'measure': '%ΔMBF', 'timeFrame': '8 weeks', 'description': 'percentage of the change between rest and CPT'}], 'secondaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': '8 weeks'}, {'measure': 'Glycated hemoglobin', 'timeFrame': '8 weeks'}, {'measure': 'Adverse effects', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endothelial dysfunction', 'Diabetes mellitus', 'glimepiride', 'metformin'], 'conditions': ['Endothelial Dysfunction', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* At least 18 years old\n* Type 2 diabetes mellitus diagnosis\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases\n* Pregnancy or lactation\n* History of abuse and/or substance dependence within 6 months preceding the survey.\n* History of glimepiride or metformin allergy'}, 'identificationModule': {'nctId': 'NCT01429818', 'briefTitle': 'Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Silanes S.A. de C.V.'}, 'officialTitle': 'Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)', 'orgStudyIdInfo': {'id': 'PET-GLI01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glimepiride/metformin', 'interventionNames': ['Drug: Glimepiride/metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Glimepiride/metformin', 'type': 'DRUG', 'otherNames': ['GLIMETAL'], 'description': '4/1000 mg tablets once a day foe eight weeks', 'armGroupLabels': ['Glimepiride/metformin']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['PREDIAL'], 'description': '1000 mg tablets once daily for eight weeks', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04510', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Jorge González, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Laboratorios Silanes S.A. de C.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Silanes S.A. de C.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}