Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-28 @ 7:10 AM
Study NCT ID:
NCT00554450
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2007-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Impairment in Type 2 Diabetic Subjects
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2007-11-05', 'studyFirstSubmitQcDate': '2007-11-05', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine', 'timeFrame': 'on Days -1, 1, 4 and 10'}, {'measure': 'Blood samples for serum glucose and creatinine will be collected', 'timeFrame': 'on Days -1, 1, 4 and 10 at selected timepoints'}, {'measure': 'Blood and urine PK samples', 'timeFrame': 'on Days 1, 4, 10'}, {'measure': 'Iohexol PK blood & urine samples for GFR assessment', 'timeFrame': 'on Day -12 to -5'}], 'secondaryOutcomes': [{'measure': 'AEs, vital signs', 'timeFrame': 'scr, Days -1, 1, 4-11, discharge'}, {'measure': 'physical exams', 'timeFrame': 'scr, Days -12 to -5, -1, discharge'}, {'measure': 'ECGs', 'timeFrame': 'scr, Days,-1, 4, 7, discharge'}, {'measure': 'clinical labs', 'timeFrame': 'scr, Day -1, 1, 4, 6, 8, 10, discharge'}, {'measure': 'The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only)', 'timeFrame': 'on Days -1, 1, 4 and 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '23210765', 'type': 'RESULT', 'citation': 'Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3631&filename=MB102007%20_Redacted%20_CSR%20_synopsis.pdf', 'label': 'MB102007 \\_Redacted \\_CSR \\_synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Subjects in the following groups:\n\nGroup A: Healthy Subjects with Normal Renal Function (CLcr \\> 80 mL/min) Group B: Diabetic Subjects with Normal Renal Function (CLcr \\> 80 mL/min) Group C: Diabetic Subjects with Mild Renal Impairment (CLcr \\> 50 - ≤80 mL/min) Group D: Diabetic Subjects with Moderate Renal Impairment (CLcr ≥ 30 - ≤50 mL/min) Group E: Diabetic Subjects with Severe Renal Impairment (CLcr \\< 30 mL/min) (and not receiving dialysis)\n\n* Men and WOCBP, ages 18 to 79 years old\n\nStandard Exclusion Criteria, plus:\n\n* History of diabetic ketoacidosis\n* HbA\\*1c \\> 10%\n* Serum albumin \\< 2.0 gm/dL\n* Potassium \\< 3.0 or \\> 6.0 mEq/L'}, 'identificationModule': {'nctId': 'NCT00554450', 'briefTitle': 'Renal Impairment in Type 2 Diabetic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment', 'orgStudyIdInfo': {'id': 'MB102-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': '50 mg single dose', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': '20 mg up to 7 days', 'interventionNames': ['Drug: Dapagliflozin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Tablets, Oral, once daily', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Elite Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism Research', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dgd Research, Inc.', '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'}}}}