Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-30 @ 4:46 AM
Study NCT ID:
NCT01006603
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2009-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502994', 'term': 'saxagliptin'}, {'id': 'C057619', 'term': 'glimepiride'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Boaz Hirshberg , MSD', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "No publication or presentation may include any of AZ's confidential information without AZ's prior written approval.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The at Risk population includes only those randomized subjects who took at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily', 'otherNumAtRisk': 359, 'otherNumAffected': 130, 'seriousNumAtRisk': 359, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily', 'otherNumAtRisk': 359, 'otherNumAffected': 129, 'seriousNumAtRisk': 359, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ISCHAEMIC CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'EPIGASTRIC DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HIATUS HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MELAENA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SUBILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DEVICE DISLOCATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ANAPHYLACTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'GASTROENTERITIS NOROVIRUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'INFECTIOUS PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LABYRINTHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'UROSEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LUMBAR VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CONCUSSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'FEMUR FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HAND FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MUSCLE RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MEDICAL OBSERVATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPOGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'JOINT EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SPINAL COLUMN STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BLADDER TRANSITIONAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BREAST CANCER IN SITU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HEPATIC NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LUNG CANCER METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PANCREATIC CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SALIVARY GLAND CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'EPILEPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CALCULUS BLADDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CALCULUS URETERIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'NEUROGENIC BLADDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SURGICAL AND MEDICAL PROCEDURES CARDIOVERSION Systematic Assessment 0 359 1 359', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'AORTIC ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'AORTIC ARTERIOSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CIRCULATORY COLLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'OG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}], 'classes': [{'title': 'All patients', 'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000'}, {'value': '38.2', 'groupId': 'OG001'}]}]}, {'title': 'patients aged <75 years (n=217, n=216)', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'patients aged ≥75 years (n=142, n=143)', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 0 to week 52.', 'description': 'Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.\n\nConfirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level \\<3 mmol/L (\\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \\<3 mmol/L (\\<54 mg/dL).\n\nMajor (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \\<3 mmol/L (\\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'OG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 0 to week 52.', 'description': 'Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level \\<3 mmol/L (\\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \\<3 mmol/L (\\<54 mg/dL).\n\nMajor (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \\<3 mmol/L (\\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in HbA1c.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'OG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '-0.37'}, {'value': '-0.64', 'groupId': 'OG001', 'lowerLimit': '-0.71', 'upperLimit': '-0.57'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From week 0 to week 52.', 'description': 'Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.', 'unitOfMeasure': '% of glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'OG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}, {'value': '54.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 0 to week 52', 'description': 'Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set.', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'OG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.73', 'groupId': 'OG000', 'lowerLimit': '-0.89', 'upperLimit': '-0.57'}, {'value': '-1.29', 'groupId': 'OG001', 'lowerLimit': '-1.45', 'upperLimit': '-1.13'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From week 0 to week 52', 'description': 'Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'OG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '-1.0'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From week 0 to week 52', 'description': 'Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set.', 'unitOfMeasure': 'µU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'OG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.83', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '6.88'}, {'value': '16.22', 'groupId': 'OG001', 'lowerLimit': '13.23', 'upperLimit': '19.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From week 0 to week 52', 'description': 'β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'FG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride : 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Completed lead-in period and were randomised', 'groupId': 'FG000', 'numSubjects': '360'}, {'comment': 'Completed lead-in period and were randomised', 'groupId': 'FG001', 'numSubjects': '360'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '285'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '75'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Safety reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Incorrect enrolment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'In total, 152 study centres in 13 countries recruited patients in this study. The first patient was enrolled in the study on 20 October 2009, and the last patient completed the study on 14 June 2012. 957 subjects were enrolled. 753 were deemed eligible for lead-in and 720 were randomized.', 'preAssignmentDetails': 'A 2-week single-blind (to patient only) placebo lead-in period occurred from Week -2 to Week 0. Patients were from this period on,counselled on dietary and lifestyle modifications according to usual clinical routine. They were given a glucometer to check their plasma glucose at home at least every second day.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg, oral tablet, once daily'}, {'id': 'BG001', 'title': 'Glimepiride 1 - 6 mg', 'description': 'Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '360', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '5.72', 'groupId': 'BG000'}, {'value': '72.7', 'spread': '5.44', 'groupId': 'BG001'}, {'value': '72.6', 'spread': '5.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 957}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2009-10-31', 'resultsFirstSubmitDate': '2013-06-12', 'studyFirstSubmitQcDate': '2009-11-02', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-27', 'studyFirstPostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.', 'timeFrame': 'From week 0 to week 52.', 'description': 'Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.\n\nConfirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level \\<3 mmol/L (\\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \\<3 mmol/L (\\<54 mg/dL).\n\nMajor (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \\<3 mmol/L (\\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.', 'timeFrame': 'From week 0 to week 52.', 'description': 'Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level \\<3 mmol/L (\\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \\<3 mmol/L (\\<54 mg/dL).\n\nMajor (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \\<3 mmol/L (\\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set.'}, {'measure': 'Change From Baseline to Week 52 in HbA1c.', 'timeFrame': 'From week 0 to week 52.', 'description': 'Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.'}, {'measure': 'Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%', 'timeFrame': 'From week 0 to week 52', 'description': 'Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set.'}, {'measure': 'Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)', 'timeFrame': 'From week 0 to week 52', 'description': 'Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set.'}, {'measure': 'Change From Baseline to Week 52 in Insulin', 'timeFrame': 'From week 0 to week 52', 'description': 'Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set.'}, {'measure': 'Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]', 'timeFrame': 'From week 0 to week 52', 'description': 'β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'elderly patients', 'saxagliptin', 'randomised', 'double-blind'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '27823868', 'type': 'DERIVED', 'citation': 'Perl S, Cook W, Wei C, Ohman P, Hirshberg B. Effects of Glimepiride versus Saxagliptin on beta-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Clin Ther. 2016 Dec;38(12):2578-2588. doi: 10.1016/j.clinthera.2016.10.006. Epub 2016 Nov 4.'}, {'pmid': '25761977', 'type': 'DERIVED', 'citation': 'Schernthaner G, Duran-Garcia S, Hanefeld M, Langslet G, Niskanen L, Ostgren CJ, Malvolti E, Hardy E. Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Diabetes Obes Metab. 2015 Jul;17(7):630-8. doi: 10.1111/dom.12461. Epub 2015 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin monotherapy, for at least 8 weeks prior to Visit 1\n* HbA1c ≥7.0% and ≤9.0%\n\nExclusion Criteria:\n\n* Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Current use of any injectable or oral antihyperglycemic agent excluding metformin.\n* Renal impairment as defined by a creatinine clearance \\<60 mL/min\n* Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study'}, 'identificationModule': {'nctId': 'NCT01006603', 'acronym': 'GENERATION', 'briefTitle': 'Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy', 'orgStudyIdInfo': {'id': 'D1680L00002'}}, 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