Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT00984867
Status:
COMPLETED
Last Update Posted:
2014-06-13
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dapagliflozin DPPIV Inhibitor add-on Study
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'}]}}, '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 8 and/or 24 weeks, respectively, LOCF was used. All endpoints were evaluated by excluding data after rescue with the exception of systolic blood pressure which was evaluated regardless of rescue medication.'}}, 'adverseEventsModule': {'timeFrame': 'Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.', 'otherNumAtRisk': 226, 'otherNumAffected': 14, 'seriousNumAtRisk': 226, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.', 'otherNumAtRisk': 225, 'otherNumAffected': 9, 'seriousNumAtRisk': 225, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Medical device pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eczema nummular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Mean Change in HbA1c Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.0509', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.14'}, {'value': '-0.45', 'spread': '0.0509', 'groupId': 'OG001', 'lowerLimit': '-0.55', 'upperLimit': '-0.35'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '-0.34', 'pValueComment': 'Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \\& key secondary objectives, based on data from both strata combined', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0720', 'groupDescription': 'H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group and stratum as effects and baseline value as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.1741', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '0.09'}, {'value': '-2.14', 'spread': '0.1745', 'groupId': 'OG001', 'lowerLimit': '-2.48', 'upperLimit': '-1.80'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.89', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '-1.40', 'pValueComment': 'Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2466', 'groupDescription': 'H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group and stratum as effects and baseline value as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.0775', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.18'}, {'value': '-0.80', 'spread': '0.0797', 'groupId': 'OG001', 'lowerLimit': '-0.96', 'upperLimit': '-0.65'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.62', 'pValueComment': 'Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1106', 'groupDescription': 'H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group and stratum as effects and baseline value as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, participants with baseline HbA1c \\>=8% and Week 24 (LOCF) value'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.81', 'spread': '2.3474', 'groupId': 'OG000', 'lowerLimit': '-0.80', 'upperLimit': '8.42'}, {'value': '-24.11', 'spread': '2.3474', 'groupId': 'OG001', 'lowerLimit': '-28.73', 'upperLimit': '-19.50'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.92', 'ciLowerLimit': '-34.45', 'ciUpperLimit': '-21.40', 'pValueComment': 'Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.3200', 'groupDescription': 'H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group and stratum as effects and baseline value as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.12', 'spread': '1.0211', 'groupId': 'OG000', 'lowerLimit': '-7.14', 'upperLimit': '-3.11'}, {'value': '-5.98', 'spread': '1.0638', 'groupId': 'OG001', 'lowerLimit': '-8.08', 'upperLimit': '-3.89'}]}]}], 'analyses': [{'pValue': '0.5583', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-3.75', 'ciUpperLimit': '2.03', 'pValueComment': 'Not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4659', 'groupDescription': 'H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group and stratum as effects and baseline value as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 8', 'description': 'To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP \\>=130 achieved with dapagliflozin versus placebo from baseline to week 8.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, participants with baseline SBP\\>=130mmHg and Week 8 (LOCF) value'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.84', 'spread': '2.5098', 'groupId': 'OG000', 'lowerLimit': '-11.77', 'upperLimit': '-1.90'}, {'value': '-21.65', 'spread': '2.4604', 'groupId': 'OG001', 'lowerLimit': '-26.49', 'upperLimit': '-16.81'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.82', 'ciLowerLimit': '-21.73', 'ciUpperLimit': '-7.90', 'pValueComment': 'Not significant. Hierarchical testing procedure stopped at previous endpoint', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.5160', 'groupDescription': 'H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment group and stratum as effect and baseline value as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '2.491', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '21.4'}, {'value': '35.3', 'spread': '3.083', 'groupId': 'OG001', 'lowerLimit': '29.3', 'upperLimit': '41.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.7', 'ciLowerLimit': '11.1', 'ciUpperLimit': '26.4', 'pValueComment': 'Not significant. Hierarchical testing procedure stopped at previous endpoint', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '41.2', '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': 'Based on methodology of Zhang, Tsiatis \\& Davidian and Davidian, Tsiatis, Zhang \\& Lu, with adjustment for baseline value and stratum', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin'}, {'id': 'FG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of the 226 randomized and treated participants only 224 were included in the full analysis set.', 'groupId': 'FG000', 'numSubjects': '226'}, {'comment': 'Of the 225 randomized and treated participants only 223 were included in the full analysis set.', 'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'site closing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'lack of efficacy and subject compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First participant enrolled: 10 Oct 2009. Last participant last visit for 24-week period: 10 Mar 2011. 833 participants were enrolled, 452 randomized and 451 treated in 3 European countries, USA, Argentina and Mexico. Participants with T2DM who showed inadequate glycemic control (7.0% ≤ HbA1c ≤ 10.0% at randomization) on sitagliptin +/- metformin.', 'preAssignmentDetails': 'During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Participants eligible for the study were stratified according to use of metformin.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo plus sitagliptin alone or in combination with metformin'}, {'id': 'BG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '10.20', 'groupId': 'BG000'}, {'value': '54.8', 'spread': '10.42', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '10.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.97', 'spread': '0.778', 'groupId': 'BG000'}, {'value': '7.90', 'spread': '0.806', 'groupId': 'BG001'}, {'value': '7.93', 'spread': '0.792', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'HbA1c [%]', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '89.23', 'spread': '20.887', 'groupId': 'BG000'}, {'value': '91.02', 'spread': '21.637', 'groupId': 'BG001'}, {'value': '90.12', 'spread': '21.259', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FPG', 'classes': [{'categories': [{'measurements': [{'value': '162.97', 'spread': '34.452', 'groupId': 'BG000'}, {'value': '162.19', 'spread': '36.825', 'groupId': 'BG001'}, {'value': '162.58', 'spread': '35.618', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Seated SBP in subjects with baseline seated SBP ≥130 mmHg', 'classes': [{'categories': [{'measurements': [{'value': '139.30', 'spread': '8.507', 'groupId': 'BG000'}, {'value': '140.46', 'spread': '8.018', 'groupId': 'BG001'}, {'value': '139.85', 'spread': '8.279', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', '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': 833}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-09', 'studyFirstSubmitDate': '2009-09-23', 'resultsFirstSubmitDate': '2013-01-21', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-09', 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Mean Change in HbA1c Levels', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean Change in Body Weight', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.'}, {'measure': 'Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.'}, {'measure': 'Adjusted Mean Change in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.'}, {'measure': 'Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg', 'timeFrame': 'Baseline to Week 8', 'description': 'To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP \\>=130 achieved with dapagliflozin versus placebo from baseline to week 8.'}, {'measure': 'Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.'}, {'measure': 'Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline', 'timeFrame': 'Baseline to Week 24', 'description': 'To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.'}]}, 'conditionsModule': {'keywords': ['Dapagliflozin DPP IV inhibitor add on study', 'Inadequate control'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '24144654', 'type': 'RESULT', 'citation': 'Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-50. doi: 10.2337/dc13-0467. Epub 2013 Oct 21.'}, {'pmid': '38770818', 'type': 'DERIVED', 'citation': 'Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=292&filename=D1690C00010_Study_Synopsis_1Mar2012.pdf', 'label': 'D1690C00010\\_Clinical\\_Study\\_Report\\_Synopsis'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=292&filename=D1690C00010_Revised_CSP1_and_Amdt_1_Priv_Redacted.pdf', 'label': 'D1690C00010\\_Revised\\_CSP1\\_and\\_Amdt\\_1\\_Priv\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with type 2 diabetes\n* Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these\n* Patients will be screened by a blood test and only those who need additional therapy can be enrolled\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes\n* Patients with very poorly controlled diabetes\n* Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study"}, 'identificationModule': {'nctId': 'NCT00984867', 'briefTitle': 'Dapagliflozin DPPIV Inhibitor add-on Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin', 'orgStudyIdInfo': {'id': 'D1690C00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Dapagliflozin 10 mg tablet', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Matching placebo tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': '10 mg tablet, oral, once daily, 48 weeks', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo tablet', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Ozark', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.45906, 'lon': -85.64049}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 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