Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-25 @ 5:55 AM
Study NCT ID:
NCT02419612
Status:
COMPLETED
Last Update Posted:
2020-06-23
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
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': 'C502994', 'term': 'saxagliptin'}, {'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C057619', 'term': 'glimepiride'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1 877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks.', 'description': 'The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 99, 'seriousNumAtRisk': 227, 'deathsNumAffected': 1, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 106, 'seriousNumAtRisk': 216, 'deathsNumAffected': 3, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 25, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 41, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 28, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chronic inflammatory demyelinating polyradiculoneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal wall infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Limb traumatic amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hormone level abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'OG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.35', 'groupId': 'OG000', 'lowerLimit': '-1.49', 'upperLimit': '-1.22'}, {'value': '-0.98', 'groupId': 'OG001', 'lowerLimit': '-1.12', 'upperLimit': '-0.84'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.099', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for for treatment, baseline HbA1c, visit, treatment-by-visit interaction, and baseline HbA1c-by-visit interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.', 'unitOfMeasure': '% HbA1c', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Body Weight at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'OG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.11', 'groupId': 'OG000', 'lowerLimit': '-3.65', 'upperLimit': '-2.57'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '1.51'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.06', 'ciLowerLimit': '-4.84', 'ciUpperLimit': '-3.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.397', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for for treatment, baseline body weight, visit, treatment-by-visit interaction, and baseline body weight-by-visit interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'OG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000', 'lowerLimit': '37.45', 'upperLimit': '51.32'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '27.87', 'upperLimit': '41.33'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.29', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline HbA1c value'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Therapeutic glycemic response was defined as HbA1c \\<7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'OG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-4.4', 'upperLimit': '-0.8'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '2.9'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '-1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.35', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, baseline SBP, visit, treatment-by-visit interaction, and baseline SBP-by-visit interaction'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'OG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.50', 'pValueComment': 'This endpoint did not meet the required number of events (n=10) in each treatment arm, hence was excluded from sequential testing.', 'groupDescription': 'Time to treatment intensification was analyzed using a Cox proportional hazards model.', 'statisticalMethod': 'Regression, Cox Proportional Hazards', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'OG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.68', 'groupDescription': 'Time to treatment intensification was analyzed using a Cox proportional hazards model.', 'statisticalMethod': 'Regression, Cox Proportional Hazards', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 156', 'description': 'Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'OG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '16.30', 'upperLimit': '27.64'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '8.03', 'upperLimit': '16.82'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '1.23', 'ciUpperLimit': '3.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline HbA1c value.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 156', 'description': 'Therapeutic glycemic response was defined as HbA1c \\<7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'OG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not calculable as less than 50% of the subjects took rescue therapy or discontinued for lack of glycemic control before Week 156.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '92.3', 'groupId': 'OG001', 'lowerLimit': '73.0', 'upperLimit': '105.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.68', 'statisticalMethod': 'Regression, Cox Proportional Hazards', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 156', 'description': 'Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'FG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}], 'periods': [{'title': 'Short-term Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '217'}]}, {'type': 'Recevied Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Subject Request To Discontinue Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Worsening of liver function', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject moved out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Long-term Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Not all subjects who completed the previous period were eligible to enter the long-term period.', 'groupId': 'FG000', 'numSubjects': '196'}, {'comment': 'Not all subjects who completed the previous period were eligible to enter the long-term period.', 'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '183'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Non-compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 444 subjects were randomized in this international, multi-center study which was conducted at 88 centers in 10 countries between 14 Aug 2015 and 18 September 2019.', 'preAssignmentDetails': 'The study duration was up to 160 weeks, consisting of a 2-week screening period, 2-week lead-in period, 52-week short-term treatment period, and 104-week long-term treatment period (156-week treatment period). One subject did not start the short-term treatment period and so only 443 subjects received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapagliflozin 10mg and Saxagliptin 5mg', 'description': 'Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day'}, {'id': 'BG001', 'title': 'Titrated Glimepiride', 'description': 'Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '10.11', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '9.23', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '9.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian Or Alaska Native', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Black Or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian Or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics are presented for the randomized subjects data set which included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-08', 'size': 1885312, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-12T04:21', 'hasProtocol': True}, {'date': '2019-10-08', 'size': 2306025, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-08T10:00', 'hasProtocol': False}]}}, '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': 444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-22', 'studyFirstSubmitDate': '2015-04-14', 'resultsFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-18', 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Body Weight at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.'}, {'measure': 'Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52', 'timeFrame': 'At Week 52', 'description': 'Therapeutic glycemic response was defined as HbA1c \\<7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.'}, {'measure': 'Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period', 'timeFrame': 'Up to Week 52', 'description': 'Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period.'}, {'measure': 'Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.', 'timeFrame': 'Up to Week 156', 'description': 'Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period.'}, {'measure': 'Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156', 'timeFrame': 'At Week 156', 'description': 'Therapeutic glycemic response was defined as HbA1c \\<7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.'}, {'measure': 'Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.', 'timeFrame': 'Up to Week 156', 'description': 'Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '32052516', 'type': 'DERIVED', 'citation': 'Frias JP, Gonzalez-Galvez G, Johnsson E, Maaske J, Testa MA, Simonson DC, Dronamraju N, Garcia-Sanchez R, Peters AL. Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial. Diabetes Obes Metab. 2020 Jul;22(7):1083-1093. doi: 10.1111/dom.13997. Epub 2020 Mar 9.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4128&filename=CV181365_CSP.PDF', 'label': 'CV181365\\_CSP\\_redacted'}]}, 'descriptionModule': {'briefSummary': 'This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.'}, '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* Subjects must be willing and able to give signed and dated written informed consent\n* Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control\n* Subjects should have been taking the same daily dose of metformin ≥ 1500 mg\n* Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)\n* Males and females, aged ≥18 years old at time of screening visit\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test\n* WOCBP and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug\n\nExclusion Criteria:\n\n* Clinical diagnosis of type I diabetes\n* History of diabetic ketoacidosis\n* Cardiovascular/vascular diseases within 3 months of the enrollment\n* Renal disease\n* Hepatic diseases\n* History of, or currently, acute or chronic pancreatitis\n* Hematological and oncological disease/conditions\n* Patients who have contraindications to therapy being studied\n* Patients on weight loss program(s)\n* Replacement or chronic systemic corticosteroid therapy'}, 'identificationModule': {'nctId': 'NCT02419612', 'briefTitle': 'A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone', 'orgStudyIdInfo': {'id': 'CV181-365'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo', 'description': 'Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally', 'interventionNames': ['Drug: Saxagliptin', 'Drug: Dapagliflozin', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Glimepiride or Placebo', 'description': 'Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally', 'interventionNames': ['Drug: Glimepiride', 'Other: Placebo']}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'armGroupLabels': ['Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo']}, {'name': 'Dapagliflozin', 'type': 'DRUG', 'armGroupLabels': ['Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo']}, {'name': 'Glimepiride', 'type': 'DRUG', 'armGroupLabels': ['Glimepiride or Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Glimepiride or Placebo', 'Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United 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