Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-12 @ 11:14 AM
Study NCT ID:
NCT02681094
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C502994', 'term': 'saxagliptin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialtransparency@astrazeneca.com', 'phone': '+46 766 346712', 'title': 'Global Clinical Leader', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From time of randomization, and throughout the treatment period and until end of treatment (Visit 5)/early termination + 4 days for non serious AEs and 30 days for SAEs.', 'description': 'An undesirable medical condition could be symptoms (eg, nausea, chest pain), signs (eg, tachycardia, enlarged liver)/abnormal results of an investigation (eg, laboratory findings, electrocardiogram). One participant was randomized but did not receive treatment in Dapagliflozin+Metformin and Saxagliptin + Metformin groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin + Saxagliptin + Metformin', 'description': 'Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)', 'otherNumAtRisk': 293, 'deathsNumAtRisk': 293, 'otherNumAffected': 41, 'seriousNumAtRisk': 293, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Dapagliflozin + Metformin', 'description': 'Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)', 'otherNumAtRisk': 293, 'deathsNumAtRisk': 293, 'otherNumAffected': 39, 'seriousNumAtRisk': 293, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Saxagliptin + Metformin', 'description': 'Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)', 'otherNumAtRisk': 295, 'deathsNumAtRisk': 295, 'otherNumAffected': 29, 'seriousNumAtRisk': 295, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Basal ganglia haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Lumbosacral radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin + Saxagliptin + Metformin', 'description': 'Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'OG001', 'title': 'Dapagliflozin + Metformin', 'description': 'Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'OG002', 'title': 'Saxagliptin + Metformin', 'description': 'Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.03', 'spread': '0.0558', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.0560', 'groupId': 'OG001'}, {'value': '-0.69', 'spread': '0.0551', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '-0.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '-0.19', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set.\n\nNote: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication.', 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin + Saxagliptin + Metformin', 'description': 'Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'OG001', 'title': 'Dapagliflozin + Metformin', 'description': 'Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'OG002', 'title': 'Saxagliptin + Metformin', 'description': 'Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.8', 'ciLowerLimit': '12.7', 'ciUpperLimit': '26.9', 'statisticalMethod': 'Method of Zhang, Tsiatis, and Davidian', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0018', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '4.4', 'ciUpperLimit': '19.1', 'statisticalMethod': 'Method of Zhang, Tsiatis, and Davidian', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 24', 'description': 'To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 \\<7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin + Saxagliptin + Metformin', 'description': 'Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'OG001', 'title': 'Dapagliflozin + Metformin', 'description': 'Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'OG002', 'title': 'Saxagliptin + Metformin', 'description': 'Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.53', 'spread': '2.1557', 'groupId': 'OG000'}, {'value': '-19.95', 'spread': '2.1738', 'groupId': 'OG001'}, {'value': '-12.66', 'spread': '2.1373', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0135', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.58', 'ciLowerLimit': '-13.59', 'ciUpperLimit': '-1.57', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.88', 'ciLowerLimit': '-20.85', 'ciUpperLimit': '-8.91', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set.', 'unitOfMeasure': 'Milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).'}, {'type': 'SECONDARY', 'title': 'Change in Total Body Weight at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin + Saxagliptin + Metformin', 'description': 'Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'OG001', 'title': 'Saxagliptin + Metformin', 'description': 'Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.01', 'spread': '0.1829', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.1815', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.60', 'ciLowerLimit': '-2.11', 'ciUpperLimit': '-1.09', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set.', 'unitOfMeasure': 'Kilograms (Kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin + Saxagliptin + Metformin', 'description': 'Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'FG001', 'title': 'Dapagliflozin + Metformin', 'description': 'Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'FG002', 'title': 'Saxagliptin + Metformin', 'description': 'Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)'}], 'periods': [{'title': '1 -Modified Enrolled Participants Set', 'milestones': [{'type': 'STARTED', 'comment': '7 participants of 1 US site were excluded due to serious Good Clinical Practice (GCP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}, {'comment': 'A participant was randomized but did not receive treatment', 'groupId': 'FG001', 'numSubjects': '294'}, {'comment': 'A participant was randomized but did not receive treatment', 'groupId': 'FG002', 'numSubjects': '296'}]}, {'type': 'Participants Completed Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '276'}, {'groupId': 'FG002', 'numSubjects': '283'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed study treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '255'}, {'groupId': 'FG002', 'numSubjects': '243'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Participant decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Study-specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'No treatment given', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': '2 - Enrolled Participants Set', 'milestones': [{'type': 'STARTED', 'comment': 'Includes 7 participants of one US site which was excluded in Modified Enrolled participants set', 'achievements': [{'comment': 'Population was used for the sensitivity analysis to assess the robustness of the treatment effect.', 'groupId': 'FG000', 'numSubjects': '301'}, {'comment': 'Population was used for the sensitivity analysis to assess the robustness of the treatment effect.', 'groupId': 'FG001', 'numSubjects': '302'}, {'comment': 'Population was used for the sensitivity analysis to assess the robustness of the treatment effect.', 'groupId': 'FG002', 'numSubjects': '302'}]}, {'type': 'Participants Completed Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'comment': 'A participant was randomized but did not receive treatment due to screen failure.', 'groupId': 'FG001', 'numSubjects': '284'}, {'comment': 'A participant was randomized but did not receive treatment due to screen failure.', 'groupId': 'FG002', 'numSubjects': '289'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed study treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}, {'groupId': 'FG001', 'numSubjects': '261'}, {'groupId': 'FG002', 'numSubjects': '248'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Participant decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Study specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'No treatment given', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 119 sites in 6 countries: Canada, Czech Republic, Germany, Mexico, Russia, and United States (US). Approximately 900 participants were to be randomized. Participants with Type 2 Diabetes (T2DM) inadequately controlled on metformin alone were randomized in this study.', 'preAssignmentDetails': 'All participants had screening (Visit 0) at 1 week prior to enrolment to screen the eligibility based on non-fasting sample of Glycated haemoglobin (Hb A1c); results of HbA1c determined enrolment based on inclusion/exclusion criteria. An abbreviated informed consent was signed and review of concomitant or other medications/therapies were performed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '870', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapagliflozin + Saxagliptin + Metformin', 'description': 'Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'BG001', 'title': 'Dapagliflozin + Metformin', 'description': 'Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'BG002', 'title': 'Saxagliptin + Metformin', 'description': 'Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '10.68', 'groupId': 'BG000'}, {'value': '55.9', 'spread': '10.94', 'groupId': 'BG001'}, {'value': '57.0', 'spread': '9.94', 'groupId': 'BG002'}, {'value': '56.7', 'spread': '10.53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '419', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '451', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '293', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '577', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}, {'value': '780', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS): All randomized participants who took at least 1 dose of study drug \\& had baseline value for HbA1c. Analysis was based on randomized treatment. Modified FAS - all participants from FAS with the exception of participants from one site (United States; excluded due to serious Good Clinical Practice \\[GCP\\] violations).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-04', 'size': 1000523, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-06T06:08', 'hasProtocol': True}, {'date': '2017-08-09', 'size': 2381562, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-06T06:08', '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': 905}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2016-02-10', 'resultsFirstSubmitDate': '2018-07-06', 'studyFirstSubmitQcDate': '2016-02-10', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-10', 'studyFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set.\n\nNote: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks', 'timeFrame': 'Baseline and week 24', 'description': 'To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 \\<7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set.'}, {'measure': 'Change in Fasting Plasma Glucose at 24 Weeks', 'timeFrame': 'Baseline and week 24', 'description': 'To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set.'}, {'measure': 'Change in Total Body Weight at 24 Weeks', 'timeFrame': 'Baseline and week 24', 'description': 'To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus Type 2,', 'saxagliptin,', 'dapagliflozin,', 'metformin'], 'conditions': ['Type 2 Diabetes Mellitus', 'Inadequate Glycaemic Control']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3863&filename=d1683c00005_csp_Redacted.pdf', 'label': 'd1683c00005 csp Redacted'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3863&filename=D1683C00005_SAP_redacted.pdf', 'label': 'D1683C00005 SAP redacted'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged ≥18 years old at time of informed consent;\n2. Patients with Type 2 diabetes mellitus (T2DM) defined as HbA1C≥7.5% to ≤10.0% at screening visit;\n3. Stable metformin therapy for at least 8 weeks prior to enrolment at a dose of ≥1500mg per day;\n4. BMI ≤45.0kg/m2 at Enrolment visit;\n5. Fasting Plasma Glucose (FPG) ≤ 270mg/dl(15.0mmol/L) at the enrolment visit;\n6. For Females Only: Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study medication in such a manner that the risk of pregnancy is minimized.\n\nExclusion Criteria:\n\n1. History of diabetes insipidus, Type 1 diabetes or Latent Autoimmune Diabetes of Adults, diabetic ketoacidosis or hyperosmolar nonketotic coma and Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to Enrolment (Visit 1), or other signs and symptoms.\n2. History of pancreatitis.\n3. Administration of any antihyperglycaemic therapy, other than metformin, for more than 14 days (consecutive or not) during the 8 weeks prior to enrolment\n4. Any use of DPP-4 inhibitor or SGLT-2 inhibitor within 8 weeks prior to enrolment.\n5. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency and/or significant abnormal liver function, including patients with Alanine transaminase (ALT) and/or Aspartate transaminase (AST) ≥3x ULN (Upper Limit of Normal)and/or Total Bilirubin ≥2.0x ULN. History of severe hepatobiliary disease or hepatotoxicity with any medication. Positive serologic evidence of current infectious liver disease, including patients who are known to be positive for Hepatitis viral antibody ImmunoglobulinM (IgM), Hepatitis B surface antigen, and Hepatitis C virus antibody.\n6. Moderate or severe impairment of renal function \\[defined as Estimated Glomerular Filtration Rate (eGFR) \\<60milliLitre/min/1.73 m2 (estimated by Modification in Diet and Renal Disease (MDRD)) or serum creatinine ≥1.5mg/dL in males or ≥1.4mg/dL in females\\]. Conditions of congenital renal glucosuria, history of unstable or rapidly progressing renal disease.\n7. History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the patient at risk because of participation in the study, may influence the results, or may limit the patient's ability to participate in or complete the study."}, 'identificationModule': {'nctId': 'NCT02681094', 'briefTitle': 'A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered With Dapagliflozin 5mg Compared to Saxagliptin 5mg or Dapagliflozin 5mg All Given as Add-on Therapy to Metformin inPatients With Type 2 Diabetes Who Have 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