Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
Study NCT ID:
NCT01217892
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2010-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Dapagliflozin Taken Twice-daily
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'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Eva Johnsson', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'For participants who did not complete 16 weeks LOCF (last observation carried forward) was used.'}}, 'adverseEventsModule': {'timeFrame': 'Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.', 'description': 'Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.', 'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin 2.5mg BID Plus Metformin', 'description': 'Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose', 'otherNumAtRisk': 100, 'otherNumAffected': 8, 'seriousNumAtRisk': 100, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Dapagliflozin 5mg BID Plus Metformin', 'description': 'Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose', 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Dapagliflozin 10mg OD Plus Metformin', 'description': 'Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose', 'otherNumAtRisk': 99, 'otherNumAffected': 6, 'seriousNumAtRisk': 99, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo Plus Metformin', 'description': 'Placebo plus Metformin, oral, twice daily, \\>=1500mg total daily dose', 'otherNumAtRisk': 101, 'otherNumAffected': 9, 'seriousNumAtRisk': 101, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'SICK SINUS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'FEMORAL ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ENDOMETRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Mean Change in HbA1c Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 2.5mg BID Plus Metformin', 'description': 'Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG001', 'title': 'Dapagliflozin 5mg BID Plus Metformin', 'description': 'Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG002', 'title': 'Dapagliflozin 10mg OD Plus Metformin', 'description': 'Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG003', 'title': 'Placebo Plus Metformin', 'description': 'Placebo plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.0594', 'groupId': 'OG000', 'lowerLimit': '-0.63', 'upperLimit': '-0.40'}, {'value': '-0.65', 'spread': '0.0600', 'groupId': 'OG001', 'lowerLimit': '-0.77', 'upperLimit': '-0.53'}, {'value': '-0.59', 'spread': '0.0598', 'groupId': 'OG002', 'lowerLimit': '-0.70', 'upperLimit': '-0.47'}, {'value': '-0.30', 'spread': '0.0593', 'groupId': 'OG003', 'lowerLimit': '-0.42', 'upperLimit': '-0.18'}]}]}], 'analyses': [{'pValue': '0.0106', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.05', 'pValueComment': "significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.", 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0840', 'groupDescription': "The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group as effect (all treatment groups included) and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '-0.18', 'pValueComment': "significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.", 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0843', 'groupDescription': "The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group as effect (all treatment groups included) and baseline value as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values'}, {'type': 'SECONDARY', 'title': 'Adjusted Percent Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 2.5mg BID Plus Metformin', 'description': 'Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG001', 'title': 'Dapagliflozin 5mg BID Plus Metformin', 'description': 'Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG002', 'title': 'Dapagliflozin 10mg OD Plus Metformin', 'description': 'Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG003', 'title': 'Placebo Plus Metformin', 'description': 'Placebo plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.84', 'spread': '0.3099', 'groupId': 'OG000'}, {'value': '-3.20', 'spread': '0.3125', 'groupId': 'OG001'}, {'value': '-2.76', 'spread': '0.3086', 'groupId': 'OG002'}, {'value': '-1.04', 'spread': '0.3105', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.82', 'ciLowerLimit': '-2.53', 'ciUpperLimit': '-1.10', 'pValueComment': 'significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3630', 'groupDescription': 'The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group (all treatment groups included) and stratum (HbA1c \\<7.0% vs \\>=7.0% at randomization) as effect and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.18', 'ciLowerLimit': '-2.89', 'ciUpperLimit': '-1.46', 'pValueComment': 'significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3636', 'groupDescription': 'The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group (all treatment groups included) and stratum (HbA1c \\<7.0% vs \\>=7.0% at randomization) as effect and baseline value as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 2.5mg BID Plus Metformin', 'description': 'Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG001', 'title': 'Dapagliflozin 5mg BID Plus Metformin', 'description': 'Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG002', 'title': 'Dapagliflozin 10mg OD Plus Metformin', 'description': 'Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG003', 'title': 'Placebo Plus Metformin', 'description': 'Placebo plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.7', 'spread': '2.657', 'groupId': 'OG000'}, {'value': '-14.7', 'spread': '2.672', 'groupId': 'OG001'}, {'value': '-15.5', 'spread': '2.634', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '2.584', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.7', 'ciLowerLimit': '-21.7', 'ciUpperLimit': '-9.7', 'pValueComment': 'significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.040', 'groupDescription': 'The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group (all treatment groups included) and stratum (HbA1c \\<7.0% vs \\>=7.0% at randomization) as effect and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.7', 'ciLowerLimit': '-22.7', 'ciUpperLimit': '-10.7', 'pValueComment': 'significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.039', 'groupDescription': 'The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group (all treatment groups included) and stratum (HbA1c \\<7.0% vs \\>=7.0% at randomization) as effect and baseline value as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 1', 'description': 'To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 1 values'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 2.5mg BID Plus Metformin', 'description': 'Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG001', 'title': 'Dapagliflozin 5mg BID Plus Metformin', 'description': 'Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG002', 'title': 'Dapagliflozin 10mg OD Plus Metformin', 'description': 'Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG003', 'title': 'Placebo Plus Metformin', 'description': 'Placebo plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.8', 'spread': '2.738', 'groupId': 'OG000'}, {'value': '-25.6', 'spread': '2.759', 'groupId': 'OG001'}, {'value': '-20.4', 'spread': '2.720', 'groupId': 'OG002'}, {'value': '-10.4', 'spread': '2.669', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.4', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '-4.2', 'pValueComment': 'significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.132', 'groupDescription': 'The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group (all treatment groups included) and stratum (HbA1c \\<7.0% vs \\>=7.0% at randomization) as effect and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-21.4', 'ciUpperLimit': '-9.1', 'pValueComment': 'significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.139', 'groupDescription': 'The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group (all treatment groups included) and stratum (HbA1c \\<7.0% vs \\>=7.0% at randomization) as effect and baseline value as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 2.5mg BID Plus Metformin', 'description': 'Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG001', 'title': 'Dapagliflozin 5mg BID Plus Metformin', 'description': 'Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG002', 'title': 'Dapagliflozin 10mg OD Plus Metformin', 'description': 'Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'OG003', 'title': 'Placebo Plus Metformin', 'description': 'Placebo plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}], 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000', 'lowerLimit': '24.6', 'upperLimit': '42.5'}, {'value': '38.2', 'groupId': 'OG001', 'lowerLimit': '29.1', 'upperLimit': '47.3'}, {'value': '28.1', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': '37.1'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '13.2', 'upperLimit': '29.6'}]}]}], 'analyses': [{'pValue': '0.0455', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.2', 'ciLowerLimit': '0.2', 'ciUpperLimit': '24.1', 'pValueComment': 'significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.097', 'groupDescription': 'H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Methodology of Zhang, Tsiatis \\& Davidian and Davidian, Tsiatis, Zhang \\& Lu, with adjustment for baseline value.', 'testedNonInferiority': False}, {'pValue': '0.0062', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.8', 'ciLowerLimit': '4.8', 'ciUpperLimit': '28.9', 'pValueComment': 'significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.153', 'groupDescription': 'H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Methodology of Zhang, Tsiatis \\& Davidian and Davidian, Tsiatis, Zhang \\& Lu, with adjustment for baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'To compare the adjusted proportions controlling for baseline HbA1c \\[acc. to Zhang, Tsiatis \\& Davidian and Davidian, Tsiatis, Zhang \\& Lu\\] of participants with HbA1c \\<7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin 2.5mg BID Plus Metformin', 'description': 'Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'FG001', 'title': 'Dapagliflozin 5mg BID Plus Metformin', 'description': 'Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'FG002', 'title': 'Dapagliflozin 10mg OD Plus Metformin', 'description': 'Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'FG003', 'title': 'Placebo Plus Metformin', 'description': 'Placebo plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lab value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Incorrect enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Poor/Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First participant enrolled: 5 November 2010. Last participant last visit for the 16-week period: 25 August 2011. 520 participants were enrolled, and 400 were randomized in 53 study centers in Europe and South Africa. Subjects with T2DM who showed inadequate glycemic control on metformin therapy alone.', 'preAssignmentDetails': 'During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Subjects eligible for the study were stratified according to their baseline HbA1c.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '399', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapagliflozin 2.5mg BID Plus Metformin', 'description': 'Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'BG001', 'title': 'Dapagliflozin 5mg BID Plus Metformin', 'description': 'Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'BG002', 'title': 'Dapagliflozin 10mg OD Plus Metformin', 'description': 'Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'BG003', 'title': 'Placebo Plus Metformin', 'description': 'Placebo plus Metformin, oral, twice daily, \\>=1500mg total daily dose'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '9.01', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '9.34', 'groupId': 'BG001'}, {'value': '58.5', 'spread': '9.78', 'groupId': 'BG002'}, {'value': '58.5', 'spread': '9.40', 'groupId': 'BG003'}, {'value': '57.7', 'spread': '9.45', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '220', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '179', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.77', 'spread': '0.747', 'groupId': 'BG000'}, {'value': '7.78', 'spread': '0.762', 'groupId': 'BG001'}, {'value': '7.71', 'spread': '0.709', 'groupId': 'BG002'}, {'value': '7.94', 'spread': '0.848', 'groupId': 'BG003'}, {'value': '7.80', 'spread': '0.770', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent [%]', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '153.3', 'spread': '33.27', 'groupId': 'BG000'}, {'value': '155.3', 'spread': '31.92', 'groupId': 'BG001'}, {'value': '155.3', 'spread': '36.26', 'groupId': 'BG002'}, {'value': '157.8', 'spread': '35.93', 'groupId': 'BG003'}, {'value': '155.4', 'spread': '34.30', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '92.49', 'spread': '18.632', 'groupId': 'BG000'}, {'value': '93.62', 'spread': '16.641', 'groupId': 'BG001'}, {'value': '90.58', 'spread': '15.929', 'groupId': 'BG002'}, {'value': '88.82', 'spread': '15.327', 'groupId': 'BG003'}, {'value': '91.37', 'spread': '16.716', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-16', 'studyFirstSubmitDate': '2010-10-07', 'resultsFirstSubmitDate': '2013-01-21', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-31', 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Mean Change in HbA1c Levels', 'timeFrame': 'Baseline to Week 16', 'description': 'To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.'}], 'secondaryOutcomes': [{'measure': 'Adjusted Percent Change in Body Weight', 'timeFrame': 'Baseline to Week 16', 'description': 'To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.'}, {'measure': 'Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1', 'timeFrame': 'Baseline to Week 1', 'description': 'To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.'}, {'measure': 'Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.'}, {'measure': 'Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.', 'timeFrame': 'Baseline to Week 16', 'description': 'To compare the adjusted proportions controlling for baseline HbA1c \\[acc. to Zhang, Tsiatis \\& Davidian and Davidian, Tsiatis, Zhang \\& Lu\\] of participants with HbA1c \\<7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'metformin treated', 'inadequate control', 'metformin treatment alone'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '25200570', 'type': 'BACKGROUND', 'citation': 'Schumm-Draeger PM, Burgess L, Koranyi L, Hruba V, Hamer-Maansson JE, de Bruin TW. Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial. Diabetes Obes Metab. 2015 Jan;17(1):42-51. doi: 10.1111/dom.12387. Epub 2014 Oct 16.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=296&filename=CSR-D1691C00003.pdf', 'label': 'CSR-D1691C00003.pdf'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=296&filename=D1691C00003_Clinical_Study_Protocol_Redacted_10Jun2014.pdf', 'label': 'D1691C00003\\_Clinical\\_Study\\_Protocol\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Diagnosis of T2DM\n* Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy \\>/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.\n* HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.\n\nExclusion Criteria:\n\n* Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus\n* History of diabetic ketoacidosis\n* Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment\n* FPG \\>270 mg/dL (\\>15.0 mmol/L)\n* BMI \\>45 kg/m2'}, 'identificationModule': {'nctId': 'NCT01217892', 'briefTitle': 'Evaluation of Dapagliflozin Taken Twice-daily', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy', 'orgStudyIdInfo': {'id': 'D1691C00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Dapagliflozin 2.5 mg twice-daily plus open-label metformin', 'interventionNames': ['Drug: dapagliflozin', 'Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Dapagliflozin 5.0 mg twice-daily plus open-label metformin', 'interventionNames': ['Drug: dapagliflozin', 'Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Dapagliflozin 10 mg once-daily plus open-label metformin', 'interventionNames': ['Drug: dapagliflozin', 'Drug: metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Placebo plus open-label metformin', 'interventionNames': ['Drug: metformin', 'Drug: placebo']}], 'interventions': [{'name': 'dapagliflozin', 'type': 'DRUG', 'description': '2.5 mg tablet, taken orally, twice daily', 'armGroupLabels': ['1']}, {'name': 'dapagliflozin', 'type': 'DRUG', 'description': '5 mg tablet taken orally, twice daily', 'armGroupLabels': ['2']}, {'name': 'dapagliflozin', 'type': 'DRUG', 'description': '10 mg tablet taken orally, once daily', 'armGroupLabels': ['3']}, {'name': 'metformin', 'type': 'DRUG', 'description': '\\>/= 1500 mg total daily dose, tablets taken orally, twice daily', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aßlar', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.59163, 'lon': 8.46273}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Biberach A.d. Riss', 'country': 'Germany', 'facility': 'Research Site'}, {'city': 'Bosenheim', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.84472, 'lon': 7.91382}}, {'city': 'Dippoldiswalde', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.89621, 'lon': 13.66905}}, {'city': 'Falkensee', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.56014, 'lon': 13.0927}}, {'city': 'Meissen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.16158, 'lon': 13.4737}}, {'city': 'München', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Neuwied', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.4336, 'lon': 7.47057}}, {'city': 'Pirna', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.95843, 'lon': 13.93702}}, {'city': 'Wahlstedt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 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