Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 1:32 AM
Study NCT ID:
NCT00726505
Status:
TERMINATED
Last Update Posted:
2016-10-17
First Post:
2008-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Mechanism of Action/Splay vs. TmG
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': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2008-07-30', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in urinary glucose excretion dynamics', 'timeFrame': 'after 7 days of treatment'}], 'secondaryOutcomes': [{'measure': 'Differences in urinary glucose between healthy and diabetic subjects', 'timeFrame': 'at 7 days'}, {'measure': 'Changes in liver glucose production', 'timeFrame': 'at one day'}, {'measure': 'Glucose effects on tubular markers', 'timeFrame': 'at one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes, NOS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3635&filename=MB102020%20_Redacted%20_CSR%20_synopsis.pdf', 'label': 'MB102020 \\_Redacted \\_CSR \\_synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects\n* Age 18 to 65 years\n* BMI 18 to 35 kg/m2\n* Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin\n* No evidence of impaired renal function\n\nExclusion Criteria:\n\n* Unwilling or unable to use an acceptable method of birth control\n* Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B\n* Exposure to insulin\n* Use of exclusionary concomitant medications\n* Evidence of significant kidney disease or any other significant medical or psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT00726505', 'acronym': 'MOA', 'briefTitle': 'Renal Mechanism of Action/Splay vs. TmG', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'MB102-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Subjects with T2DM - Dapagliflozin 5 mg', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Subjects with T2DM - Dapagliflozin 20 mg', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Healthy Subjects - Dapagliflozin 20 mg', 'interventionNames': ['Drug: Dapagliflozin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['BMS-512148'], 'description': 'Tablets, Oral, Once Daily, up to 29 days:', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University Of Texas Health Center At San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}