Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT03864705
Status:
UNKNOWN
Last Update Posted:
2020-09-11
First Post:
2019-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compliance of Diabetic Patients Treated With Metformin
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2019-03-03', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma metformin levels', 'timeFrame': 'At the time of measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Metformin is the 1st line treatment in all subjects with type 2 diabetes without a contraindication to its use. The compliance with the use of metformin is not optimal mainly owing to relatively frequent gastrointestinal side effects. However, hard data about the real compliance are currently not available.\n\nIn this trial we aim at assessing the compliance with metformin intake using a combination of serum metformin measurement and a specific questionnaire. We will further evaluate the impact of different pharmacological forms of metformin (standard vs. XR - extended release) on its compliance and try to identify common characteristics associated with reduced compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with type 2 diabetes mellitus on metformin therapy for at least 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus on metformin therapy for at least 3 months\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03864705', 'acronym': 'CODAMET', 'briefTitle': 'Compliance of Diabetic Patients Treated With Metformin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute for Clinical and Experimental Medicine'}, 'officialTitle': 'Compliance of Diabetic Patients Treated With Metformin', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Measurement of plasma metformin levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects on chronic metformin therapy will have their plasma metformin levels measured during a regular check-up with glycated hemoglobin assessment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14021', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Martin Haluzik, Prof. DSc.', 'role': 'CONTACT', 'email': 'martin.haluzik@ikem.cz', 'phone': '+420261361111'}], 'facility': 'Institute for Clinical and Experimental Medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Martin Haluzik, Prof. DSc.', 'role': 'CONTACT', 'email': 'martin.haluzik@ikem.cz', 'phone': '261361111'}], 'overallOfficials': [{'name': 'Martin Haluzik, Prof. DSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Clinical and Experimental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Scientist', 'investigatorFullName': 'Martin Haluzik', 'investigatorAffiliation': 'Institute for Clinical and Experimental Medicine'}}}}