Viewing Study NCT02471404

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Ignite Creation Date: 2025-12-24 @ 9:07 PM
Ignite Modification Date: 2026-01-21 @ 7:09 AM
Study NCT ID: NCT02471404
Status: COMPLETED
Last Update Posted: 2019-03-26
First Post: 2015-06-11
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C502994', 'term': 'saxagliptin'}, {'id': 'C057619', 'term': 'glimepiride'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+46 (0)31776 24 84', 'title': 'Eva Johnsson, MD, PhD', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent.', 'description': 'Safety Analysis Set (All randomised subjects who received at least 1 dose of study medication) N=313, 312, 312 for Dapa, Saxa+Dapa, Glim respectively. subjects excluded from the Safety Analysis Set (n=1,0, 1 for Dapa, Saxa+Dapa, Glim respectively) did not receive treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10mg + Metformin', 'otherNumAtRisk': 313, 'deathsNumAtRisk': 313, 'otherNumAffected': 29, 'seriousNumAtRisk': 313, 'deathsNumAffected': 0, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin', 'otherNumAtRisk': 312, 'deathsNumAtRisk': 312, 'otherNumAffected': 31, 'seriousNumAtRisk': 312, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin', 'otherNumAtRisk': 312, 'deathsNumAtRisk': 312, 'otherNumAffected': 37, 'seriousNumAtRisk': 312, 'deathsNumAffected': 0, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 49, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Basedow's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thyroid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vitritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis clostridial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Micrococcus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Reiter's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Scrotal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory fume inhalation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acoustic neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Melanoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Essential tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Somatic symptom disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acquired phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapaglifozin 10mg', 'description': 'Dapaglifozin 10mg + Metformin'}, {'id': 'OG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin'}, {'id': 'OG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.046', 'groupId': 'OG001'}, {'value': '-0.99', 'spread': '0.048', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.0294', 'ciUpperLimit': '0.2986', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.3443', 'ciUpperLimit': '-0.0825', 'pValueComment': '(superiority)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% Confidence Interval of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis', 'description': 'Change in HbA1c from baseline (week 0) to week 52.', 'unitOfMeasure': 'HbA1c %', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Patients With at Least One Episode of Confirmed Hypoglycaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapaglifozin 10mg', 'description': 'Dapaglifozin 10mg + Metformin'}, {'id': 'OG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin'}, {'id': 'OG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.32', 'groupId': 'OG001'}, {'value': '4.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.21', 'ciLowerLimit': '-6.45', 'ciUpperLimit': '-1.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.89', 'ciLowerLimit': '-6.21', 'ciUpperLimit': '-1.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.19', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis', 'description': 'Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose \\<=50 mg/dL) during the double-blind treatment period', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Total Body Weight From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapaglifozin 10mg', 'description': 'Dapaglifozin 10mg + Metformin'}, {'id': 'OG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin'}, {'id': 'OG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.54', 'spread': '0.231', 'groupId': 'OG000'}, {'value': '-3.15', 'spread': '0.219', 'groupId': 'OG001'}, {'value': '1.76', 'spread': '0.224', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.30', 'ciLowerLimit': '-5.93', 'ciUpperLimit': '-4.67', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.91', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '-4.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis', 'description': 'Change in body weight from baseline (week 0) to week 52', 'unitOfMeasure': 'Weight (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapaglifozin 10mg', 'description': 'Dapaglifozin 10mg + Metformin'}, {'id': 'OG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin'}, {'id': 'OG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.62', 'spread': '0.106', 'groupId': 'OG000'}, {'value': '-2.08', 'spread': '0.100', 'groupId': 'OG001'}, {'value': '-1.49', 'spread': '0.105', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.374', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.16', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.31', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis', 'description': 'Change in FPG from baseline (week 0) to week 52', 'unitOfMeasure': 'FPG (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Time to Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapaglifozin 10mg', 'description': 'Dapaglifozin 10mg + Metformin'}, {'id': 'OG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin'}, {'id': 'OG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to rescue is not estimable due to the fact that less than 50% of patients had required rescue by the end of the treatment period (52 weeks). Cpnsequently the CI is not estimable either.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to rescue is not estimable due to the fact that less than 50% of patients had required rescue by the end of the treatment period (52 weeks). Cpnsequently the CI is not estimable either.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to rescue is not estimable due to the fact that less than 50% of patients had required rescue by the end of the treatment period (52 weeks). Cpnsequently the CI is not estimable either.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.777', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.35', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.57', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Over the 52 week treatment period', 'description': 'The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Rescued', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapaglifozin 10mg', 'description': 'Dapaglifozin 10mg + Metformin'}, {'id': 'OG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin'}, {'id': 'OG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Over the 52 week treatment period', 'description': 'Number (%) of patients rescued.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10mg + Metformin'}, {'id': 'FG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin'}, {'id': 'FG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '313'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '298'}, {'groupId': 'FG002', 'numSubjects': '288'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Developed Study Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Failure to Meet Randomization Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other reasons not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}, {'value': '939', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10mg + Metformin'}, {'id': 'BG001', 'title': 'Saxagliptin 5mg and Dapagliflozin 10mg', 'description': 'Saxagliptin 5mg and Dapagliflozin 10mg + Metformin'}, {'id': 'BG002', 'title': 'Glimepiride 1mg/2mg/4mg', 'description': 'Glimepiride 1mg/2mg/4mg + Metformin'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '9.36', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '75'}, {'value': '59.2', 'spread': '7.87', 'groupId': 'BG001', 'lowerLimit': '36', 'upperLimit': '74'}, {'value': '58.6', 'spread': '8.38', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '75'}, {'value': '58.4', 'spread': '8.58', 'groupId': 'BG003', 'lowerLimit': '31', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}, {'value': '684', 'groupId': 'BG003'}]}]}, {'title': '>=65-<75', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}]}]}, {'title': '>=75', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '339', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '600', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Black Or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '311', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}, {'value': '929', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-21', 'size': 1946259, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-13T14:20', 'hasProtocol': False}, {'date': '2017-01-12', 'size': 1218463, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-13T15:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 939}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-22', 'studyFirstSubmitDate': '2015-06-11', 'resultsFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-22', 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52', 'timeFrame': 'Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis', 'description': 'Change in HbA1c from baseline (week 0) to week 52.'}], 'secondaryOutcomes': [{'measure': 'Patients With at Least One Episode of Confirmed Hypoglycaemia', 'timeFrame': 'Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis', 'description': 'Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose \\<=50 mg/dL) during the double-blind treatment period'}, {'measure': 'Change in Total Body Weight From Baseline at Week 52', 'timeFrame': 'Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis', 'description': 'Change in body weight from baseline (week 0) to week 52'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52', 'timeFrame': 'Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis', 'description': 'Change in FPG from baseline (week 0) to week 52'}, {'measure': 'Time to Rescue', 'timeFrame': 'Over the 52 week treatment period', 'description': 'The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period'}, {'measure': 'Number of Patients Rescued', 'timeFrame': 'Over the 52 week treatment period', 'description': 'Number (%) of patients rescued.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus Type 2,', 'metformin,', 'saxagliptin,', 'dapagliflozin,', 'glimepiride,', 'inadequate glycaemic control'], 'conditions': ['Type 2 Diabetes Mellitus', 'Inadequate Glycaemic Control']}, 'referencesModule': {'references': [{'pmid': '29947099', 'type': 'DERIVED', 'citation': 'Muller-Wieland D, Kellerer M, Cypryk K, Skripova D, Rohwedder K, Johnsson E, Garcia-Sanchez R, Kurlyandskaya R, Sjostrom CD, Jacob S, Seufert J, Dronamraju N, Csomos K. Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Nov;20(11):2598-2607. doi: 10.1111/dom.13437. Epub 2018 Jul 16.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3910&filename=d1689c00014_SAP_Redacted.pdf', 'label': 'd1689c00014\\_SAP\\_Redacted'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3910&filename=d1689c00014_CSP_redacted.pdf', 'label': 'd1689c00014\\_CSP\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Main Inclusion Criteria:\n\n1. Is male or female and ≥18 and \\<75 years old at time of informed consent.\n2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.\n3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.\n4. Has a BMI of ≤45 kg/m2 at Enrolment visit.\n5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.\n\nMain, Exclusion Criteria:\n\n1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.\n2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.\n3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.\n4. Concomitant treatment with loop diuretics"}, 'identificationModule': {'nctId': 'NCT02471404', 'briefTitle': 'Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy', 'orgStudyIdInfo': {'id': 'D1689C00014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin+metformin', 'description': 'Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Placebo for saxagliptin', 'Drug: Placebo for glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin+saxagliptin+metformin', 'description': 'Dapagliflozin + saxagliptin + glimepiride placebo+ metformin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Saxagliptin', 'Drug: Placebo for glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride+metformin', 'description': 'Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin', 'interventionNames': ['Drug: Glimepiride', 'Drug: Placebo for dapagliflozin', 'Drug: Placebo for saxagliptin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['Forxiga'], 'description': '10 mg, orally Green, plain, diamond-shaped, film-coated tablet', 'armGroupLabels': ['Dapagliflozin+metformin', 'Dapagliflozin+saxagliptin+metformin']}, {'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza™'], 'description': '5 mg, orally Plain, yellow, biconvex, round, film-coated tablet', 'armGroupLabels': ['Dapagliflozin+saxagliptin+metformin']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['Amaryl'], 'description': '1, 2, or 4 mg, orally Opaque gray capsule', 'armGroupLabels': ['Glimepiride+metformin']}, {'name': 'Placebo for dapagliflozin', 'type': 'DRUG', 'description': 'Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet', 'armGroupLabels': ['Glimepiride+metformin']}, {'name': 'Placebo for saxagliptin', 'type': 'DRUG', 'description': 'Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet', 'armGroupLabels': ['Dapagliflozin+metformin', 'Glimepiride+metformin']}, {'name': 'Placebo for glimepiride', 'type': 'DRUG', 'description': 'Does not contain active ingredient, orally. 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