Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-30 @ 5:20 PM
Study NCT ID:
NCT00976495
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2009-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Anna Maria Langkilde', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Tablet, oral, once daily for 12 weeks', 'otherNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dapagliflozin 10 mg', 'description': 'Tablet, oral, once daily for 12 weeks', 'otherNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Hydrochlorothiazide 25 mg', 'description': 'Tablet, oral, once daily for 12 weeks', 'otherNumAtRisk': 26, 'otherNumAffected': 9, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'POLLAKIURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}, {'term': 'NOCTURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}, {'term': 'INGROWING NAIL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}], 'seriousEvents': [{'term': 'LOCALISED INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}, {'term': 'INTERVERTEBRAL DISC INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}, {'term': 'PLEURITIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version: 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dapagliflozin 10 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Hydrochlorothiazide 25 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.92', 'spread': '2.0133', 'groupId': 'OG000'}, {'value': '-10.76', 'spread': '1.9684', 'groupId': 'OG001'}, {'value': '-3.40', 'spread': '1.9756', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.07', 'ciLowerLimit': '-13.34', 'ciUpperLimit': '-2.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7177', 'estimateComment': 'ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.62', 'ciLowerLimit': '-12.87', 'ciUpperLimit': '-2.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7068', 'estimateComment': 'ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 12', 'description': 'Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.', 'unitOfMeasure': '% Change of Baseline GFR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (MLOCF)'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dapagliflozin 10 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Hydrochlorothiazide 25 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.88', 'spread': '1.6373', 'groupId': 'OG000'}, {'value': '-3.28', 'spread': '1.7674', 'groupId': 'OG001'}, {'value': '-6.55', 'spread': '1.6833', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.40', 'ciLowerLimit': '-7.11', 'ciUpperLimit': '2.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.3613', 'estimateComment': 'ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.26', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '8.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.4112', 'estimateComment': 'ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 12', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dapagliflozin 10 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Hydrochlorothiazide 25 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.55', 'spread': '1.7247', 'groupId': 'OG000'}, {'value': '-5.93', 'spread': '1.8673', 'groupId': 'OG001'}, {'value': '-6.83', 'spread': '1.7671', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.38', 'ciLowerLimit': '-9.38', 'ciUpperLimit': '0.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5072', 'estimateComment': 'ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '-4.18', 'ciUpperLimit': '5.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5474', 'estimateComment': 'ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 12', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Dapagliflozin 10 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Hydrochlorothiazide 25 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.61', 'spread': '1.9468', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '2.0822', 'groupId': 'OG001'}, {'value': '-7.76', 'spread': '1.9857', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-5.39', 'ciUpperLimit': '5.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7812', 'estimateComment': 'ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.31', 'ciLowerLimit': '1.70', 'ciUpperLimit': '12.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.8135', 'estimateComment': 'ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 12', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'FG001', 'title': 'Dapagliflozin 10 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'FG002', 'title': 'Hydrochlorothiazide 25 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Of 154 participants enrolled, 77 completed a qualification period. Of these 77 participants, 75 were randomized and received treatment. Of these 75 participants, 74 completed double-blind treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'BG001', 'title': 'Dapagliflozin 10 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Hydrochlorothiazide 25 mg', 'description': 'Tablet, oral, once daily for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '9.50', 'groupId': 'BG000'}, {'value': '53.7', 'spread': '9.38', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '9.87', 'groupId': 'BG002'}, {'value': '55.5', 'spread': '9.63', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Younger than 65 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': '65 - 75 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2012-03-24', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2009-09-11', 'dispFirstSubmitQcDate': '2014-06-06', 'resultsFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2009-09-11', 'dispFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-18', 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])', 'timeFrame': 'From Baseline to Week 12', 'description': 'Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From Baseline to Week 12', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.'}, {'measure': 'Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From Baseline to Week 12', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.'}, {'measure': 'Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From Baseline to Week 12', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3906841/', 'label': 'Publication'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3641&filename=MB102035_Redacted_CSR_synopsis.pdf', 'label': 'MB102035\\_Redacted\\_CSR\\_synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%\n* Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit\n* Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and \\< 165 mmHg, AND/OR diastolic BP (DBP) ≥ 80 and \\< 105 mmHg\n* C-peptide ≥ 0.8 ng/mL\n* Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula \\> 60 mL/min/1.73m² and \\< 150 mL/min/1.73m²\n* Urine albumin:creatinine ratio (UACR) \\< 300 mg/g\n* BMI ≤ 45.0 kg/m2\n\nExclusion Criteria:\n\n* Administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either ACEI or ARB), at any dose during the 12 weeks prior to the enrollment visit\n* History of adverse reaction to radio-contrast dye\n* Allergy or contraindication to use of thiazide diuretics\n* Aspartate Aminotransferase (AST) \\> 3X Upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) \\> 3X ULN\n* Serum Total Bilirubin \\> 1.5X ULN\n* Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women\n* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases'}, 'identificationModule': {'nctId': 'NCT00976495', 'briefTitle': 'Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic and Blood Pressure (BP) Control', 'orgStudyIdInfo': {'id': 'MB102-035'}, 'secondaryIdInfos': [{'id': 'EUDRACT #: 2009-010221-39'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrochlorothiazide', 'interventionNames': ['Drug: Hydrochlorothiazide']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['BMS-512148'], 'description': 'Tablets, Oral, 10 mg, once daily, 12 weeks', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, once daily, 12 weeks', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Tablets, Oral, 25 mg, once daily, 12 weeks', 'armGroupLabels': ['Hydrochlorothiazide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Res Inst', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Elite Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research, Llc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University Of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism Research', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Memorial Hospital Of Rhode Island', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}, {'zip': '53295', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Zablocki Veterans Affairs Medical Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M4G 3E8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H7T 2P5', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astra Zeneca, Bristol-Myers Squibb', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}