Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT02096705
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Insulin Add-On Asia Regional Program - ST
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'Anna Maria Langkilde', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 week treatment period + 30 days', 'description': 'Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin', 'otherNumAtRisk': 139, 'otherNumAffected': 61, 'seriousNumAtRisk': 139, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin', 'otherNumAtRisk': 133, 'otherNumAffected': 61, 'seriousNumAtRisk': 133, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DYSLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYPERLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYPERURICAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'MYOCARDIAL BRIDGING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'UVEITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'LUNG INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NEUROSYPHILIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HUMERUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'FOOT DEFORMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PERIARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'SPINAL OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BILE DUCT CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'COLORECTAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ARACHNOID CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DIABETIC NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'SEIZURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'VIITH NERVE PARALYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ECTOPIC PREGNANCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CALCULUS URETERIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYDRONEPHROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Mean Change in HbA1c From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.0707', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.0666', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.71', 'pValueComment': 'P-value for Dapagliflozin vs. placebo', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0968', 'estimateComment': 'Difference of Dapagliflozin from placebo', 'statisticalMethod': 'Longitudinal repeated measure analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and 24 weeks', 'description': 'The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with non-missing baseline and at least one post-baseline value'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '3.3803', 'groupId': 'OG000'}, {'value': '-30.62', 'spread': '3.1314', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.69', 'ciLowerLimit': '-39.76', 'ciUpperLimit': '-21.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.6050', 'estimateComment': 'Difference of Dapagliflozin from placebo', 'statisticalMethod': 'Longitudinal repeated measure analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value for Dapagliflozin vs. placebo'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and 24 weeks', 'description': 'The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with non-missing baseline and at least one post-baseline value'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in Body Weight From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.37', 'spread': '0.2224', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.2103', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.38', 'ciLowerLimit': '-1.98', 'ciUpperLimit': '-0.77', 'pValueComment': 'P-value for Dapagliflozin vs. placebo', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3057', 'estimateComment': 'Difference of Dapagliflozin from placebo', 'statisticalMethod': 'Longitudinal repeated measure analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and 24 weeks', 'description': 'Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with non-missing baseline and at least one post-baseline value'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '0.3723', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.3592', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.43', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '-0.42', 'pValueComment': 'P-value for Dapagliflozin vs. placebo', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5171', 'estimateComment': 'Difference of Dapagliflozin from placebo', 'statisticalMethod': 'Longitudinal repeated measure analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and 24 weeks', 'description': 'The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).', 'unitOfMeasure': 'International Units (IU)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with non-missing baseline and at least one post-baseline value'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin'}, {'id': 'FG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin'}], 'periods': [{'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject request to discontinue treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '5 participants in this arm did not complete the treatment period and rejoined for follow-up', 'groupId': 'FG000', 'numSubjects': '129'}, {'comment': '5 participants in this arm did not complete the treatment period and rejoined for follow-up', 'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subjects not reporting status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '477 participants were enrolled; 313 entered lead-in period; 272 participants were randomized to a treatment group. Of the 205 participants not randomized to a treatment group: 190 No longer met study criteria, 11 withdrew consent, 2 were lost to follow-up, and 2 were removed for administrative reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin'}, {'id': 'BG001', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'spread': '8.91', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '8.39', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '8.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Randomized Participants'}}, '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': 477}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2014-03-24', 'resultsFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-13', 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Mean Change in HbA1c From Baseline to Week 24', 'timeFrame': 'Baseline (Day 1) and 24 weeks', 'description': 'The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24', 'timeFrame': 'Baseline (Day 1) and 24 weeks', 'description': 'The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).'}, {'measure': 'Adjusted Mean Change in Body Weight From Baseline to Week 24', 'timeFrame': 'Baseline (Day 1) and 24 weeks', 'description': 'Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).'}, {'measure': 'Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24', 'timeFrame': 'Baseline (Day 1) and 24 weeks', 'description': 'The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit\n* Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment\n\nInclusion criteria for randomization:\n\nHbA1c ≥ 7.5 and ≤ 10.5% at Day -14\n\nExclusion Criteria:\n\n* Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment\n* History of diabetic ketoacidosis of hyperosmolar nonketotic coma\n* Clinically diagnosed Type 1 diabetes mellitus\n* Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV\n* Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg\n* History of unstable or rapidly progressing renal disease\n* History of severe hepatobiliary disease\n* Mallingancy within 5 years of the screening/enrollment visit'}, 'identificationModule': {'nctId': 'NCT02096705', 'briefTitle': 'Phase III Insulin Add-On Asia Regional Program - ST', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin', 'orgStudyIdInfo': {'id': 'MB102-137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Dapagliflozin', 'description': 'Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2: Dapagliflozin Placebo', 'description': 'Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin', 'interventionNames': ['Drug: Dapagliflozin Placebo']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['BMS-512148'], 'description': 'Tablet', 'armGroupLabels': ['Group 1: Dapagliflozin']}, {'name': 'Dapagliflozin Placebo', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['Group 2: Dapagliflozin Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '150001', 'city': 'Haerbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Local Institution'}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210012', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '215004', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '214023', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '710061', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '400010', 'city': 'Chongqing', 'state': 'Sichuan', 'country': 'China', 'facility': 'Local Institution'}, {'zip': '100039', 'city': 'Beijing', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '169856', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Local Institution', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Local Institution', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '42415', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35233', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-727', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}