Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 4:08 PM
Study NCT ID:
NCT01316861
Status:
COMPLETED
Last Update Posted:
2013-09-25
First Post:
2011-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-03-12', 'releaseDate': '2021-02-23'}, {'resetDate': '2021-04-23', 'releaseDate': '2021-03-30'}, {'resetDate': '2022-07-26', 'releaseDate': '2022-07-25'}], 'estimatedResultsFirstSubmitDate': '2021-02-23'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-24', 'studyFirstSubmitDate': '2011-03-15', 'studyFirstSubmitQcDate': '2011-03-15', 'lastUpdatePostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated hemoglobin (HbA1c)', 'timeFrame': 'Change from baseline to day 98'}], 'secondaryOutcomes': [{'measure': 'Decrease in mean Fasting Plasma Glucose (FPG)', 'timeFrame': 'Change from baseline to day 14, 28, 42, 70 and 98'}, {'measure': 'Safety will be evaluated by the Adverse events occurence', 'timeFrame': 'Day 105', 'description': 'Adverse events will be collected and followed in order to evaluate safety and tolerability'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2 Diabetic Patients Using Two Different Formulations of Acarbose 50mg.', 'detailedDescription': 'Study Design:\n\n* Multicenter\n* Phase III\n* Randomized\n* Double Blind\n* Prospective and Comparative\n* Experiment duration: 105 days\n* 5 visits\n* Efficacy\n* Adverse event'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be able to understand the study procedures agree to participate and give written consent.\n* Diagnosed with type 2 diabetes mellitus (t2dm)b\n* Female patients of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) which agree to use a medically accepted contraceptive regimen for the duration of the study.\n\nExclusion Criteria:\n\n* Pregnancy or risk of pregnancy.\n* Lactation\n* Any pathology or past medical condition that can interfere with this protocol\n* Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.\n* Known hypersensitivity / intolerance to acarbose or any of its excipients'}, 'identificationModule': {'nctId': 'NCT01316861', 'briefTitle': 'Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'EMSAGL0110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMS Acarbose', 'interventionNames': ['Drug: EMS Acarbose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bayer Acarbose', 'interventionNames': ['Drug: Bayer Acarbose']}], 'interventions': [{'name': 'EMS Acarbose', 'type': 'DRUG', 'description': 'EMS Acarbose 50 mg 3 times a day', 'armGroupLabels': ['EMS Acarbose']}, {'name': 'Bayer Acarbose', 'type': 'DRUG', 'description': 'Bayer Acarbose 50 mg 3 times a day', 'armGroupLabels': ['Bayer Acarbose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12.245-000', 'city': 'São José dos Campos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Marcio Antonio Pereira Clinica', 'geoPoint': {'lat': -23.17944, 'lon': -45.88694}}], 'overallOfficials': [{'name': 'Felipe Pinho, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EMS S/A'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-02-23', 'type': 'RELEASE'}, {'date': '2021-03-12', 'type': 'RESET'}, {'date': '2021-03-30', 'type': 'RELEASE'}, {'date': '2021-04-23', 'type': 'RESET'}, {'date': '2022-07-25', 'type': 'RELEASE'}, {'date': '2022-07-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'EMS'}}}}