Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT03313661
Status:
UNKNOWN
Last Update Posted:
2018-08-27
First Post:
2017-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM 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': 'D000077465', 'term': 'Cabergoline'}, {'id': 'D005907', 'term': 'Gliclazide'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-23', 'studyFirstSubmitDate': '2017-10-14', 'studyFirstSubmitQcDate': '2017-10-14', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of fasting and post prandial BG level', 'timeFrame': '4 months', 'description': 'Fasting and post prandial BG level will be measured after 4 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'Evaluation of the glycemic efficacy of cabergoline on diabetic patients', 'detailedDescription': 'Type 2 diabetes mellitus (DM) is a progressive metabolic disorder that is associated with basal hyperinsulinemia, insulin resistance and impaired insulin release. Glycemic control is a fundamental part of the management of type 2 DM and difficult to achieve. Different antidiabetic agents can handle diabetic metabolic abnormalities. The development of antidiabetic agentswith novel mechanisms of action is highly desirable. Cabergoline, a long acting D2 agonist, is expected to play a role in the glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients.\n\nExclusion Criteria:\n\n* Other drugs administration'}, 'identificationModule': {'nctId': 'NCT03313661', 'briefTitle': 'Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients', 'orgStudyIdInfo': {'id': 'Diabetes Mellitus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cabergoline', 'description': 'cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide', 'interventionNames': ['Drug: Cabergoline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gliclazide', 'description': 'gliclazide (60-120 mg) once daily', 'interventionNames': ['Drug: Gliclazide']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': 'Placebo'}], 'interventions': [{'name': 'Cabergoline', 'type': 'DRUG', 'description': 'cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide', 'armGroupLabels': ['Cabergoline']}, {'name': 'Gliclazide', 'type': 'DRUG', 'description': 'gliclazide (60-120 mg)', 'armGroupLabels': ['Gliclazide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-elsalam, lecturer', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '00201000040794'}], 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, consultant', 'role': 'CONTACT', 'email': 'Sheriefabdelsalam@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Jouliana Atef Morcos, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Pharmacy, Tanta University, Egypt'}, {'name': 'Abla Mohamed Ebeid, Ph D', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Pharmacy, AL-Delta University, Gamasa, Egypt'}, {'name': 'Samy Abdel kader khodeir, Ph D', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University'}, {'name': 'Gamal Abdel khalek Elazab, Ph D', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Pharmacy, Tanta University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhDTropical Medicine', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}