Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-04 @ 1:38 PM
Study NCT ID:
NCT01646320
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2012-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India', 'Turkey (Türkiye)']}, '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': 'C502994', 'term': 'saxagliptin'}, {'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': 'Eva.Johnsson@astrazeneca.com', 'phone': '+46 31 7762484', 'title': 'Eva Johnsson, Clinical Science Lead', 'phoneExt': '762 484', 'organization': 'AstraZeneca Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DAPA + SAXA + MET', 'description': 'Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks', 'otherNumAtRisk': 160, 'otherNumAffected': 103, 'seriousNumAtRisk': 160, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'PLA + SAXA + MET', 'description': 'Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks', 'otherNumAtRisk': 160, 'otherNumAffected': 112, 'seriousNumAtRisk': 160, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'HEPATIC STEATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'VULVOVAGINAL MYCOTIC INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'DYSLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'HYPERTRIGLYCERIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'CARDIAC FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'VENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'GASTRIC ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'ABSCESS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'GANGRENE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'POSTOPERATIVE WOUND INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'LIVER FUNCTION TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'INVASIVE DUCTAL BREAST CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapa+Saxa+Met', 'description': 'Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Pla+Saxa+Met', 'description': 'Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.0686', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.0704', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.53', 'pValueComment': 'Tested at alpha=0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0964', 'statisticalMethod': 'Longitudinal Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.', 'unitOfMeasure': 'Percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapa+Saxa+Met', 'description': 'Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Pla+Saxa+Met', 'description': 'Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.7', 'spread': '2.821', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '2.968', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.5', 'ciLowerLimit': '-35.4', 'ciUpperLimit': '-19.6', 'pValueComment': 'Secondary end points are tested following a sequential testing procedure at alpha=0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.015', 'statisticalMethod': 'Longitudinal Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed corresponds to the number of randomized subjects with non-missing baseline value and at least one post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapa+Saxa+Met', 'description': 'Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Pla+Saxa+Met', 'description': 'Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-73.5', 'spread': '4.055', 'groupId': 'OG000'}, {'value': '-38.0', 'spread': '4.104', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.5', 'ciLowerLimit': '-46.3', 'ciUpperLimit': '-24.7', 'pValueComment': 'Secondary end points are tested following a sequential testing procedure at alpha=0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.493', 'statisticalMethod': 'Longitudinal Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': '2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed is the number of randomized subjects with non-missing baseline and Week 24 (LOCF) values.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Body Weight at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapa+Saxa+Met', 'description': 'Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Pla+Saxa+Met', 'description': 'Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.2191', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.2270', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.50', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '-0.89', 'pValueComment': 'Secondary endpoints are tested following a sequential testing procedure at alpha=0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3126', 'statisticalMethod': 'Longitudinal Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 24', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapa+Saxa+Met', 'description': 'Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}, {'id': 'OG001', 'title': 'Pla+Saxa+Met', 'description': 'Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '13.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.5', 'ciLowerLimit': '16.7', 'ciUpperLimit': '34.4', 'pValueComment': 'Secondary end points are tested following a sequential testing procedure at alpha=0.05', 'statisticalMethod': 'Modified logistic regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 24', 'description': 'Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \\<7.0%. Data after rescue medication was excluded from this analysis.', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapa+Saxa+Met', 'description': 'Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}, {'id': 'FG001', 'title': 'Pla+Saxa+Met', 'description': 'Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}], 'periods': [{'title': 'Short-term Period (Day 1 to Week 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Long-term Period (Weeks 24 to 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Subject no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial with Dapagliflozin added to Saxagliptin in Combination with Metformin compared to placebo added to Saxagliptin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin', 'preAssignmentDetails': 'Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR\n\nArm 2: Placebo + Saxagliptin + Metformin IR'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapa+Saxa+Met', 'description': 'Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}, {'id': 'BG001', 'title': 'Pla+Saxa+Met', 'description': 'Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '8.61', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '9.60', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '9.10', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'ASIAN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'BLACK/AFRICAN AMERICAN', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'OTHER', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'WHITE', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}]}, {'title': 'AMERICAN INDIAN/ALASKA NATIVE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'NATIVE HAWAIIAN/OTHER PACIFIC ISLANDER', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized subjects who received at least one dose of study medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-18', 'studyFirstSubmitDate': '2012-07-18', 'resultsFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-09', 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24', 'timeFrame': 'From Baseline to Week 24', 'description': 'HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24', 'timeFrame': 'From Baseline to Week 24', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period'}, {'measure': 'Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24', 'timeFrame': 'From Baseline to Week 24', 'description': '2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT.'}, {'measure': 'Adjusted Mean Change From Baseline in Body Weight at Week 24', 'timeFrame': 'From baseline to Week 24', 'description': 'Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.'}, {'measure': 'Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From baseline to week 24', 'description': 'Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \\<7.0%. Data after rescue medication was excluded from this analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 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.'}, {'pmid': '29802530', 'type': 'DERIVED', 'citation': 'Mathieu C, Catrinoiu D, Ranetti AE, Johnsson E, Hansen L, Chen H, Garcia-Sanchez R, Iqbal N, Celinski A. Characterization of the Open-Label Lead-In Period of Two Randomized Controlled Phase 3 Trials Evaluating Dapagliflozin, Saxagliptin, and Metformin in Type 2 Diabetes. Diabetes Ther. 2018 Aug;9(4):1703-1711. doi: 10.1007/s13300-018-0445-x. Epub 2018 May 25.'}, {'pmid': '26246458', 'type': 'DERIVED', 'citation': 'Mathieu C, Ranetti AE, Li D, Ekholm E, Cook W, Hirshberg B, Chen H, Hansen L, Iqbal N. Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes. Diabetes Care. 2015 Nov;38(11):2009-17. doi: 10.2337/dc15-0779. Epub 2015 Aug 5.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.', 'detailedDescription': 'Prior to randomization, all eligible subjects will receive open-label treatment with Saxagliptin 5mg and Metformin IR during the 16-week open-label treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Signed Written Informed Consent\n\n 1. Subjects must be willing and able to give signed and dated written informed consent.\n2. Target Population\n\n For inclusion into Stratum A:\n\n i) Subjects with T2DM with inadequate glycemic control, defined as central laboratory HbA1c ≥ 8.0 and ≤ 11.5% obtained at the screening visit (ie Week -18 visit), on stable metformin therapy alone for at least 8 weeks prior to screening visit at a dose ≥ 1500 mg per day\n\n For inclusion into Stratum B:\n\n ii) Subjects with T2DM with inadequate glycemic control, and HbA1c ≥ 7.5 and ≤ 10.5% obtained at the screening visit and on stable metformin therapy at a dose ≥ 1500 mg per day AND a DPP4 inhibitor at the maximum approved dose for at least 8 weeks prior to screening visit.\n\n b) C-peptide ≥ 1.0 ng/mL (0.34 nmol/L) at screening visit. c) BMI ≤ 45.0 kg/m2 at the screening visit.\n3. Age and Reproductive Status\n\n 1. Men and women, aged ≥ 18 years old at time of screening visit.\n 2. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.\n 3. WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product.\n 4. Women must not be breastfeeding\n 5. Sexually active fertile men must use highly effective birth control if their partners are WOCBP.\n\nExclusion Criteria\n\n1. Target Disease Exceptions\n\n 1. History of diabetes insipidus\n 2. Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the three months prior to screening, or other signs and symptoms.\n 3. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.\n2. Medical History and Concurrent Diseases\n\n 1. History of bariatric surgery or lap-band procedure within 12 months prior to screening.\n 2. Any unstable endocrine, psychiatric or rheumatic disorders as judged by the Investigator.\n 3. Subject who, in the judgment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data and concomitant use of loop diuretics in countries where this is not recognized in the Dapagliflozin label.\n 4. Subject is currently abusing alcohol or other drugs or has done so within the last 6 months.\n\n Acute Vascular Event:\n 5. Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg.\n 6. Cardiovascular Disease within 3 months of the screening visit \\[ie myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, stroke or transient ischemic attack (TIA)\\].\n 7. Congestive heart failure as New York Association (NYHA) class IV, unstable or acute congestive heart failure.\n\n Renal Diseases:\n 8. Moderate or severe impairment of renal function \\[defined as eGFR \\< 60 mL/min/1.73m2 (estimated by MDRD) or serum creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females.\\]\n 9. Conditions of congenital renal glucosuria\n\n Hepatic Diseases:\n 10. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency, including subjects with ALT and/or AST \\> 3x ULN and or Total Bilirubin \\> 2.5 x ULN.\n\n Hematological and Oncological Disease/Conditions:\n 11. History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis.\n 12. Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma)\n 13. Known immunocompromised status, including but not limited to, individuals who have undergone organ transplantation or who are positive for the human immunodeficiency virus.\n 14. Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of \\> 400 mL of blood during the 6 months prior to the screening visit.\n\n Prohibited treatment and therapies:\n 15. Administration of any antihyperglycemic therapy, other than metformin and DPP4's, for more than 14 days (consecutive or not) during the 12 weeks prior to screening, as well as previous exposure to DPP4 or SGLT-2 inhibitor in any DPP4 or SGLT-2 inhibitor trial is an exclusion criterion.\n 16. Current treatment with potent cytochrome P450 3A4/5 inhibitors (in countries where dose adjustment would be required by the dapagliflozin label).\n 17. Administration of any other investigational drug or participation in any interventional clinical studies within 30 days of planned screening to this study. Subjects who failed to satisfy all eligibility criteria at screening and did not enter the lead-in or open-label period in CV181-168 or CV181-169 studies specifically, do not need to wait 30 days.\n3. Physical and Laboratory Test Findings\n\n a) Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women\n\n b) Presence of hematuria:\n\n i) For male subjects being considered for Stratum A: microscopic hematuria present at Week -18 or Week -16 AND no common cause that can be confirmed is exclusionary. Male subjects with a confirmed common cause can be entered into the open-label phase with a documented negative result for hematuria microscopic urinalysis performed by the central laboratory.\n\n ii) For male subjects being considered for Stratum B: microscopic hematuria present at Week -10 or Week -8 AND no common cause that can be confirmed is exclusionary. Male subjects with a confirmed common cause can be entered into the open-label phase with a documented negative result for hematuria microscopic urinalysis performed by the central laboratory.\n\n NOTE: Female sub}ects with hematuria can be entered into the open-label phase and be randomized, but should be investigated according to local standards and best clinical practices. (See Appendix 3)\n\n c) Other central laboratory test findings:\n\n \\- Abnormal free T4 values. Abnormal thyroid stimulating hormone (TSH) value at screening will be further evaluated by free T4. Sub}ects with abnormal free T4 values will be excluded.\n * Positive for hepatitis B surface antigen\n * Positive for anti-hepatitis C virus antibody\n4. Allergies and Adverse Drug Reaction\n\n a) Subjects who have contraindications to therapy as outlined in the dapagliflozin and saxagliptin Investigator Brochure, the local dapagliflozin or saxagliptin package insert or the local metformin package insert, including current treatment with potent cytochrome P450 3A4/5 inhibitors (in countries where dose adjustment would be required by the local Onglyza (saxagliptin) label.\n5. Sex and Reproductive Status\n\n a) Women who are pregnant\n6. Other Exclusion Criteria\n\n 1. Prisoners or subjects who are involuntarily incarcerated\n 2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness\n 3. Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program.\n 4. Employee of BMS, AstraZeneca (AZ), or their relatives.\n 5. Subject with any condition which, in the judgment of the Investigator, may render the subject unable to complete the study or which may pose a significant risk to the subject.\n 6. Subject is a participating investigator, study coordinator, employee of an investigator or immediate family member of any of the aforementioned.\n\n Open Label Treatment Period\n\n Note: Enrollment of subjects into the open-label (Stratum A) treatment period, beginning eee -16 of the study with HbA1c values at the lower bound (≥ 8.0% and ≤ 9.0%) and Enrollment of subjects into the open-label (Stratum B) eee -8, of the study with HbA1c values at the lower bound (≥ 7.5% and ≤ 8.5%) will be limited to approximately 50% of the total number of subjects randomized.\n\n • For subject in Stratum A:\n * At Week -10 and Week -2 a FPG qualification check will be performed. Subjects with a central laboratory FPG value meeting \\> 270 mg/dL will be scheduled for a follow-up visit (within 3 - 5 days) to obtain a second central laboratory FPG value. If the mean of the originally scheduled central laboratory FPG and the repeat central laboratory FPG value is \\> 270 mg/dL, the subject cannot be randomized and must be discontinued.\n\n * For subjects in Stratum B:\n * At Week -2 a FPG qualification check will be performed. Subjects with a central laboratory FPG value meeting \\> 270 mg/dL will be scheduled for a follow-up visit (within 3 - 5 days) to obtain a second central laboratory FPG value. If the mean of the originally scheduled central laboratory FPG and the repeat central laboratory FPG value is \\> 270 mg/dL, the subject cannot be randomized and must be discontinued\n\n Double Blind Treatment Period\n\n Inclusion criteria:\n\n • For Stratum A AND Stratum B:\n\n \\- Subjects with T2DM with inadequate glycemic control, defined as central laboratory HbA1c ≥ 7.0 and ≤ 10.5% obtained at the Week -2 visit of the open-label treatment period."}, 'identificationModule': {'nctId': 'NCT01646320', 'briefTitle': 'Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxagliptin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Saxagliptin', 'orgStudyIdInfo': {'id': 'MB102-129'}, 'secondaryIdInfos': [{'id': '2011-006324-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Saxagliptin', 'Drug: Metformin immediate release (IR)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Placebo + Saxagliptin + Metformin IR', 'interventionNames': ['Drug: Placebo matching with Dapagliflozin', 'Drug: Saxagliptin', 'Drug: Metformin immediate release (IR)']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Tablets, Oral, 10 mg, Once daily, Up to 52 weeks', 'armGroupLabels': ['Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR']}, {'name': 'Placebo matching with Dapagliflozin', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, Once daily, Up to 52 weeks', 'armGroupLabels': ['Arm 2: Placebo + Saxagliptin + Metformin IR']}, {'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza'], 'description': 'Tablets, Oral, 5 mg, Once daily, Up to 52 weeks', 'armGroupLabels': ['Arm 2: Placebo + Saxagliptin + Metformin IR', 'Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR']}, {'name': 'Metformin immediate release (IR)', 'type': 'DRUG', 'description': 'Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks', 'armGroupLabels': ['Arm 2: Placebo + Saxagliptin + Metformin IR', 'Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University Of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Advantage Inc/Desert Clinical Research Llc', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Clinical Studies, Llc', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Clinical Research', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research Institute Inc.', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '90023', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Randall G. 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