Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02429258
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2015-04-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
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': 'D008687', 'term': 'Metformin'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sergey.zhuplatov@astrazeneca.com', 'phone': '215-542-3222', 'title': 'Sergey Zhuplatov MD, PhD', 'organization': 'AstraZeneca, PLL'}, 'certainAgreement': {'otherDetails': 'Institution \\& PI agree they will not use or disclose and confidential information to third parties for a period of 10 years from receipt', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin', 'otherNumAtRisk': 50, 'otherNumAffected': 3, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin', 'otherNumAtRisk': 50, 'otherNumAffected': 3, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.05'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.2', 'spread': '4.33', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '4.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-24.0', 'ciLowerLimit': '-36.1', 'ciUpperLimit': '-12.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '4.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-26.8', 'ciUpperLimit': '-3.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.80', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': 'Change in percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '2.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '15.0', 'ciLowerLimit': '7.7', 'ciUpperLimit': '22.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.65', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': 'Change in percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.6', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-16.1', 'ciLowerLimit': '-23.5', 'ciUpperLimit': '-8.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.72', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': 'Change in percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.2', 'spread': '5.99', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '5.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-29.7', 'ciLowerLimit': '-46.6', 'ciUpperLimit': '-12.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.47', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.9', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '6.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-40.8', 'ciLowerLimit': '-59.0', 'ciUpperLimit': '-22.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': '% Alc', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fructosamine From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.4', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '3.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-10.8', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '-1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.55', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4', 'denoms': [{'units': 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'SECONDARY', 'title': 'Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '1.3', 'ciUpperLimit': '12.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.86', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'unitOfMeasure': '10^-9 min^-1', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '226 subjects signed the informed consent form (ICF), and 132 subjects were screened to randomize a total of 100 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin + Metformin or Insulin'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo + Metformin or Insulin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '7.11', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '9.71', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '8.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'American Indian and Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '5.92', 'groupId': 'BG000'}, {'value': '33.2', 'spread': '5.59', 'groupId': 'BG001'}, {'value': '33.8', 'spread': '5.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'spread': '0.785', 'groupId': 'BG000'}, {'value': '8.37', 'spread': '0.810', 'groupId': 'BG001'}, {'value': '8.34', 'spread': '0.794', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '100 subjects were included in the safety and ITT population. 99 subjects were included in the evaluable population. 1 subject did not meet the I/E criteria.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-18', 'studyFirstSubmitDate': '2015-04-08', 'resultsFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-27', 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System', 'timeFrame': 'Baseline to Week 4'}], 'secondaryOutcomes': [{'measure': 'Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in HbA1c From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in Fructosamine From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population', 'timeFrame': 'Baseline to Week 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type II Diabetes']}, 'referencesModule': {'references': [{'pmid': '30222367', 'type': 'DERIVED', 'citation': 'Henry RR, Strange P, Zhou R, Pettus J, Shi L, Zhuplatov SB, Mansfield T, Klein D, Katz A. Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Nov;20(11):715-724. doi: 10.1089/dia.2018.0052. Epub 2018 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin', 'detailedDescription': 'Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus (T2DM)\n* Treated with either stable dose of metformin alone \\> or = to 1500mg/day or stable dose of insulin \\> or = to 30 units/day and up to 2 OAD medications for at least 8 weeks\n* Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening\n* Body mass index (BMI) \\< or = to 45 kg/m2\n\nExclusion Criteria:\n\n* For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening\n* For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening.\n* Use of sulfonylureas during the 8 weeks prior to screening\n* Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor\n* Ingestion of any medication know to affect glucose metabolism for \\>7 consecutive days during the 3 months prior to screening\n* Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening'}, 'identificationModule': {'nctId': 'NCT02429258', 'briefTitle': 'Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin', 'orgStudyIdInfo': {'id': 'D1690L00026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Farxiga with metformin or insulin', 'description': 'Farxiga with metformin (\\>/=1500mg/day) or insulin (\\>/=30 units/day) and up to 2 OAD medications', 'interventionNames': ['Drug: Farxiga', 'Drug: Metformin', 'Drug: Insulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo with metformin or insulin', 'description': 'Placebo with metformin (\\>/=1500mg/day) or insulin (\\>/=30 units/day) and up to 2 OAD medications', 'interventionNames': ['Drug: Placebo', 'Drug: Metformin', 'Drug: Insulin']}], 'interventions': [{'name': 'Farxiga', 'type': 'DRUG', 'description': 'Farxiga 10mg/day', 'armGroupLabels': ['Farxiga with metformin or insulin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo with metformin or insulin']}, {'name': 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