Viewing Study NCT02284893

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Ignite Creation Date: 2025-12-25 @ 1:20 AM
Ignite Modification Date: 2026-02-22 @ 7:18 AM
Study NCT ID: NCT02284893
Status: COMPLETED
Last Update Posted: 2018-06-01
First Post: 2014-11-04
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'C502994', 'term': 'saxagliptin'}, {'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'katarina.fridman@astrazeneca.com', 'phone': '+46(31)7762040', 'title': 'Katarina Fridman', 'phoneExt': '62040', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'PI to provide AstraZeneca (AZ) with an opportunity to review/comment on drafts of publication and review final draft at least 30 days in advance of submission for publication or public presentation (15 days for an abstract or poster). If requested agree to delay submission or presentation for an additional period, not more than additional 90 days, to allow AZ to file a patent or application to preserve our rights in any intellectual property disclosed in the publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'Including Data After Rescue, Treated Subjects', 'eventGroups': [{'id': 'EG000', 'title': 'SAXA + DAPA + MET', 'description': 'Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 112, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Sita + Met', 'description': 'Placebo tablet matching the saxagliptin 5-mg tablet+Placebo tablet matching the dapagliflozin 10-mg tablet+Sitagliptin 100-mg capsules+Metformin background therapy', 'otherNumAtRisk': 229, 'deathsNumAtRisk': 229, 'otherNumAffected': 123, 'seriousNumAtRisk': 229, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'DYSLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'VULVOVAGINAL MYCOTIC INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}], 'seriousEvents': [{'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'CARDIAC FAILURE CHRONIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'CONGESTIVE CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'MITRAL VALVE PROLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ANAL FISSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ADENOCARCINOMA OF COLON', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'MENINGIOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'POST LAMINECTOMY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'LOWER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'UPPER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'DYSFUNCTIONAL UTERINE BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ENDOMETRIOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'LUMBAR RADICULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'MENTAL STATUS CHANGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 19.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Dapagliflozin + Metformin Group', 'description': 'Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules'}, {'id': 'OG001', 'title': 'SITA + MET', 'description': 'Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'spread': '0.0696', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '0.0719', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1001', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization) to Week 26', 'unitOfMeasure': 'percentage (%)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Subjects data set consists of all randomized subjects who received at least\n\n1 dose of double-blind study drug during the double-blind treatment period. Data in this data set were analyzed based on randomized treatment group, even if the treatment they received was different'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Dapagliflozin + Metformin Group', 'description': 'Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules'}, {'id': 'OG001', 'title': 'SITA + MET', 'description': 'Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '3.150', 'groupId': 'OG000'}, {'value': '25.1', 'spread': '2.871', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '12.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.175', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'the analysis was by Zhang et.al. method with adjustment for baseline A1c.The measure of interest is NOT odds ratio but Risk Difference.'}], 'paramType': 'NUMBER', 'timeFrame': 'week 26', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized subjects'}, {'type': 'SECONDARY', 'title': 'Mean Change in Total Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Dapagliflozin + Metformin Group', 'description': 'Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules'}, {'id': 'OG001', 'title': 'SITA + MET', 'description': 'Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.86', 'spread': '0.2010', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.2078', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-1.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2891', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (randomization) to Week 26', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized subjects'}, {'type': 'SECONDARY', 'title': 'Mean Change in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Dapagliflozin + Metformin Group', 'description': 'Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules'}, {'id': 'OG001', 'title': 'SITA + MET', 'description': 'Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.9', 'spread': '2.538', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '2.668', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-20.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.682', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (randomization) to Week 26', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SAXA + DAPA + MET', 'description': 'Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy'}, {'id': 'FG001', 'title': 'SITA + MET', 'description': 'Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy'}], 'periods': [{'title': '26 Week (Short Term)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '229'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Discontinuation by the subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withrawal of the consent by the subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '52 Week (Long Term)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '193'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withrawal of the consent by the subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '461 Patients were Randomized into the study, 411 patients completed the 26 weeks part. Out of them 402 patients continued into the additional 26 week part. Out of them 378 patients completed the 52 weeks period (26+26 weeks).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SAXA + DAPA + MET', 'description': 'Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy'}, {'id': 'BG001', 'title': 'SITA + MET', 'description': 'Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '8.87', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '9.55', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '9.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'North America', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}]}, {'title': 'Central America', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, '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': 461}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2014-11-04', 'resultsFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-29', 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in HbA1c', 'timeFrame': 'Baseline (randomization) to Week 26'}], 'secondaryOutcomes': [{'measure': 'Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%', 'timeFrame': 'week 26'}, {'measure': 'Mean Change in Total Body Weight', 'timeFrame': 'Baseline (randomization) to Week 26'}, {'measure': 'Mean Change in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline (randomization) to Week 26'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit\n* Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening\n* BMI \\> 20.0 kg/m2 at the enrollment visit\n* Males and Females, age ≥18 years old at time of screening visit\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug\n* Women must not be breastfeeding\n\nExclusion Criteria:\n\n* Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus\n* History of diabetic ketoacidosis\n* Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit\n\n * Myocardial infarction\n * Cardiac surgery or revascularization (coronary artery bypass surgery Coronary Artery Bypass Graft \\[(CABG)\\]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty \\[(PTCA)\\])\n * Unstable angina\n * Unstable congestive heart failure (CHF)\n * Transient ischemic attack (TIA) or significant cerebrovascular disease\n * Unstable or previously undiagnosed arrhythmia\n * Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%\n* Renal Disease\n* Hepatic Diseases\n* Hematological and Oncological Disease/Conditions\n* Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women\n* Abnormal Free T4'}, 'identificationModule': {'nctId': 'NCT02284893', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone', 'orgStudyIdInfo': {'id': 'CV181-363'}, 'secondaryIdInfos': [{'id': '2014-001102-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1:Saxagliptin / Placebo + Dapagliflozin / Placebo', 'description': 'Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily)', 'interventionNames': ['Drug: Saxagliptin', 'Drug: Dapagliflozin', 'Drug: Placebo matching with Saxagliptin', 'Drug: Placebo matching with Dapagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'A2: Sitagliptin / placebo', 'description': 'Sitagliptin 100 mg and matching placebo 0 mg (once daily)', 'interventionNames': ['Drug: Sitagliptin', 'Drug: Placebo matching with Sitagliptin']}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'description': 'administered orally once daily', 'armGroupLabels': ['A1:Saxagliptin / Placebo + Dapagliflozin / Placebo']}, {'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'administered orally once daily', 'armGroupLabels': ['A1:Saxagliptin / Placebo + Dapagliflozin / Placebo']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'administered orally once daily', 'armGroupLabels': ['A2: Sitagliptin / placebo']}, {'name': 'Placebo matching with Saxagliptin', 'type': 'DRUG', 'description': 'administered orally once daily', 'armGroupLabels': ['A1:Saxagliptin / Placebo + Dapagliflozin / Placebo']}, {'name': 'Placebo matching with Dapagliflozin', 'type': 'DRUG', 'description': 'administered orally once daily', 'armGroupLabels': ['A1:Saxagliptin / Placebo + Dapagliflozin / Placebo']}, {'name': 'Placebo matching with Sitagliptin', 'type': 'DRUG', 'description': 'administered orally once daily', 'armGroupLabels': ['A2: Sitagliptin / placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 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