Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT02104804
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502994', 'term': 'saxagliptin'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}], 'ancestors': [{'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Eva.Johnsson@astrazeneca.com', 'title': 'Eva Johnsson, MD, PhD, Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'Without limitation to any other right of AstraZeneca hereunder, Institution and Principal Investigator acknowledge and agree that only AZ as Sponsor will register the Study and post the Study results in accordance with AZ internal policy on one or more publicly-accessible trial registries and websites (including the publicly-funded website http://www.clinicaltrials.gov/ and on its own website http://www.astrazenecaclinicaltrials.com) to avoid duplication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Total numbers at risk indicate the number of participants in the Safety Analysis set. Out of 466 randomized, 1 did not take study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'PLACEBO QD + INSULIN WITH OR WITHOUT METFORMIN', 'otherNumAtRisk': 231, 'otherNumAffected': 96, 'seriousNumAtRisk': 231, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'SAXAGLIPTIN 5 MG QD + INSULIN WITH OR WITHOUT METFORMIN', 'otherNumAtRisk': 234, 'otherNumAffected': 89, 'seriousNumAtRisk': 234, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysbacteriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Periodontal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatitis E', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypochloraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 131, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 171, 'numAffected': 51}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, 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Placebo Plus Insulin', 'description': 'Patients receiving placebo 5 mg plus insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-4702.2', 'groupId': 'OG000', 'lowerLimit': '-5813.3', 'upperLimit': '-3591.0'}, {'value': '1431.0', 'groupId': 'OG001', 'lowerLimit': '294.4', 'upperLimit': '2567.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6133.2', 'ciLowerLimit': '-7668.5', 'ciUpperLimit': '-4597.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '781.06', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 weeks', 'unitOfMeasure': 'mg*min/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '213 and 206 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.'}, {'type': 'SECONDARY', 'title': 'Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Plus Insulin', 'description': 'Saxagliptin 5 mg plus insulin'}, {'id': 'OG001', 'title': 'Vs. Placebo Plus Insulin', 'description': 'Patients receiving placebo 5 mg plus insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.28', 'groupId': 'OG000', 'lowerLimit': '-37.76', 'upperLimit': '-22.80'}, {'value': '8.84', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.42'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Difference in Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.11', 'ciLowerLimit': '-49.41', 'ciUpperLimit': '-28.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '215 and 211 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Plus Insulin', 'description': 'Saxagliptin 5 mg plus insulin'}, {'id': 'OG001', 'title': 'Vs. Placebo Plus Insulin', 'description': 'Patients receiving placebo 5 mg plus insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '3.1', 'ciUpperLimit': '12.6', 'statisticalMethod': 'Difference in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': '229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.'}, {'type': 'SECONDARY', 'title': 'The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Plus Insulin', 'description': 'Saxagliptin 5 mg plus insulin'}, {'id': 'OG001', 'title': 'Vs. Placebo Plus Insulin', 'description': 'Patients receiving placebo 5 mg plus insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.23', 'groupId': 'OG000', 'lowerLimit': '-15.34', 'upperLimit': '-7.11'}, {'value': '4.65', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '8.80'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.88', 'ciLowerLimit': '-21.53', 'ciUpperLimit': '-10.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.88', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Average of Weeks 20 and 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '232 and 229 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 229 for this outcome measure respectively.'}, {'type': 'SECONDARY', 'title': 'Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Plus Insulin', 'description': 'Saxagliptin 5 mg plus insulin'}, {'id': 'OG001', 'title': 'Vs. Placebo Plus Insulin', 'description': 'Patients receiving placebo 5 mg plus insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '0.14'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '-0.19', 'upperLimit': '0.27'}]}]}], 'analyses': [{'pValue': '0.430', 'groupIds': ['OG001'], 'paramType': 'Difference in Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 weeks', 'unitOfMeasure': 'IU', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '232 and 230 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saxagliptin Plus Insulin', 'description': 'Saxagliptin 5 mg plus insulin'}, {'id': 'FG001', 'title': 'Vs. Placebo Plus Insulin', 'description': 'Patients receiving placebo 5 mg plus insulin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of patients who were randomized', 'groupId': 'FG000', 'numSubjects': '234'}, {'comment': 'Number of patients who were randomized', 'groupId': 'FG001', 'numSubjects': '232'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of patients who completed 24 weeks of treatment', 'groupId': 'FG000', 'numSubjects': '218'}, {'comment': 'Of the 19 who did not complete, 1 did not take study medication after randomization.', 'groupId': 'FG001', 'numSubjects': '213'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Did not take study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other listed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': "This study was performed at 22 sites in the People's Republic of China (PRC).The first patient was enrolled on 07 May 2014 and the last patient completed the study on 26 February 2016. The study was divided into a single-blind placebo lead-in period of 8 weeks, a treatment period of 24 weeks and a follow-up phase of 4 weeks.", 'preAssignmentDetails': '953 patients were enrolled, of which 641 patients took at least 1 dose of study drug and entered the lead-in period. A total of 312 patients did not enter the lead-in period (289 did not fulfill eligibility criteria, 21 due to subject decision, 1 each for severe non-compliance to protocol and other reasons) and 466 patients were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saxagliptin Plus Insulin', 'description': 'Saxagliptin 5 mg plus insulin'}, {'id': 'BG001', 'title': 'Vs. Placebo Plus Insulin', 'description': 'Patients receiving placebo 5 mg plus insulin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '7.93', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '8.17', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '8.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline HbA1C', 'classes': [{'categories': [{'measurements': [{'value': '8.52', 'spread': '0.69', 'groupId': 'BG000'}, {'value': '8.53', 'spread': '0.70', 'groupId': 'BG001'}, {'value': '8.53', 'spread': '0.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '7.28', 'groupId': 'BG000'}, {'value': '13.3', 'spread': '6.35', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '6.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '167.94', 'spread': '31.39', 'groupId': 'BG000'}, {'value': '167.34', 'spread': '32.86', 'groupId': 'BG001'}, {'value': '167.64', 'spread': '32.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '0-180 min Post Prandial Glucose AUC', 'classes': [{'categories': [{'measurements': [{'value': '45457.6', 'spread': '8433.08', 'groupId': 'BG000'}, {'value': '43851.4', 'spread': '9051.26', 'groupId': 'BG001'}, {'value': '44661.5', 'spread': '8772.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg*min/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '120-min Post Prandial Glucose', 'classes': [{'categories': [{'measurements': [{'value': '278.0', 'spread': '58.00', 'groupId': 'BG000'}, {'value': '270.0', 'spread': '63.30', 'groupId': 'BG001'}, {'value': '274.0', 'spread': '60.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Glucagon', 'classes': [{'categories': [{'measurements': [{'value': '40.007', 'spread': '23.68', 'groupId': 'BG000'}, {'value': '40.231', 'spread': '21.06', 'groupId': 'BG001'}, {'value': '40.119', 'spread': '22.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting C-peptide', 'classes': [{'categories': [{'measurements': [{'value': '1.029', 'spread': '0.52', 'groupId': 'BG000'}, {'value': '1.012', 'spread': '0.58', 'groupId': 'BG001'}, {'value': '1.020', 'spread': '0.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Metformin use at enrolment', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Tolerated Daily Dose of Insulin', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '16.49', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '14.68', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '15.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Insulin Dose Units', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Note that 462 indicates the number of patients in the Full Analysis set (out of 466 randomized, 1 did not take study drug and 3 did not have 1 baseline or post baseline efficacy assessment).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 953}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2014-04-02', 'resultsFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-04', 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline to Week 24', 'timeFrame': 'Baseline to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test', 'timeFrame': 'Baseline to 24 weeks'}, {'measure': 'Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test', 'timeFrame': 'Baseline to 24 weeks'}, {'measure': 'Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%', 'timeFrame': 'At Week 24'}, {'measure': 'The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)', 'timeFrame': 'Baseline to Average of Weeks 20 and 24'}, {'measure': 'Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24', 'timeFrame': 'Baseline to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus, Insulin, Dipeptidyl-Peptidase 4 Inhibitors, Metformin,saxagliptin,Endocrine System Diseases'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '17337495', 'type': 'RESULT', 'citation': 'Drucker DJ. Dipeptidyl peptidase-4 inhibition and the treatment of type 2 diabetes: preclinical biology and mechanisms of action. Diabetes Care. 2007 Jun;30(6):1335-43. doi: 10.2337/dc07-0228. Epub 2007 Mar 2. No abstract available.'}, {'pmid': '1244564', 'type': 'RESULT', 'citation': 'Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.'}, {'pmid': '17387446', 'type': 'RESULT', 'citation': 'Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007 Jun;50(6):1148-55. doi: 10.1007/s00125-007-0633-0. Epub 2007 Mar 27.'}, {'pmid': '22081481', 'type': 'RESULT', 'citation': 'Pan CY, Yang W, Tou C, Gause-Nilsson I, Zhao J. Efficacy and safety of saxagliptin in drug-naive Asian patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Metab Res Rev. 2012 Mar;28(3):268-75. doi: 10.1002/dmrr.1306.'}, {'pmid': '20092585', 'type': 'RESULT', 'citation': 'Vilsboll T, Rosenstock J, Yki-Jarvinen H, Cefalu WT, Chen Y, Luo E, Musser B, Andryuk PJ, Ling Y, Kaufman KD, Amatruda JM, Engel SS, Katz L. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Feb;12(2):167-77. doi: 10.1111/j.1463-1326.2009.01173.x.'}, {'pmid': '21871686', 'type': 'RESULT', 'citation': 'Yang W, Pan CY, Tou C, Zhao J, Gause-Nilsson I. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Res Clin Pract. 2011 Nov;94(2):217-24. doi: 10.1016/j.diabres.2011.07.035. Epub 2011 Aug 26.'}, {'pmid': '29144061', 'type': 'DERIVED', 'citation': 'Chen Y, Liu X, Li Q, Ma J, Lv X, Guo L, Wang C, Shi Y, Li Y, Johnsson E, Wang M, Zhao J, Ji L. Saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin with or without metformin: Results from the SUPER study, a randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2018 Apr;20(4):1044-1049. doi: 10.1111/dom.13161. Epub 2017 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination with Metformin', 'detailedDescription': "Study Design: Randomized, prospective, double-blind, two-arm, parallel group, multi-center trial.\n\nTarget Subject Population: Subjects aged ≥18 who have type 2 diabetes (HbA1c of ≥7.5% and ≤11.0% and FPG\\<270 mg/dL (15 mmol/L)) on stable baseline therapy (insulin alone or insulin combined with metformin, with insulin at doses of ≥20 and ≤150 units per day total) for at least eight weeks at the time of screening. Insulin may be long-acting, intermediate-acting, or pre-mixed. 444 patients are planned to be randomized.\n\nInvestigational Product, Dosage and Mode of administration: Active treatment will comprise Saxagliptin 5 mg tablets once daily.\n\nComparator, Dosage and Mode of administration: Matching placebo tablets will be used as comparator.\n\nDuration of Treatment: The study is divided to a single blind placebo lead in period of 8 weeks and a double-blind treatment phase of 24 weeks. Patients will be rescued based on high FPG values.\n\nStatistical Methods: The analysis of the primary endpoint of change from baseline to week 24 of treatment in HbA1c will consist of an analysis of covariance (ANCOVA) model with treatment group and metformin use at enrolment as fixed effects and baseline HbA1c value as a covariate. The analysis will be performed on the Full analysis Set (FAS) consisting of randomised subjects who received at least 1 randomised investigational product dose and had at least 1 non-missing baseline and 1 post-baseline efficacy assessment. Within the framework of the ANCOVA model, point estimates and two-sided 95% confidence intervals (CI) for the mean change within each treatment group as well as for the difference in mean change between treatment groups will be calculated.\n\nThe Per Protocol (PP) analysis set is a subset of the full analysis set and will consist of subjects who do not deviate from the terms of the protocol which may affect the study outcome significantly as specified in the pre-defined protocol deviation list prior to unblinding the study. All decisions to exclude subjects from the primary data set will be made prior to the unblinding of the study. The primary efficacy endpoint of change from baseline in HbA1c, demographics, and baseline diabetes related characteristics and all secondary efficacy endpoints are to be analyzed using the PP Data Set. The analyses of PPG AUC, 120 minute PPG, FPG and mean total daily dose of insulin will also be done on the FAS and use a similar ANCOVA model as described above. Subjects achieving a therapeutic glycaemic response (A1C \\<7%) will be analyzed using a Fisher's exact test and will include exact 95% confidence intervals. The FPG analyses will utilize the mean of the latest two FPG values prior to randomization as the baseline value. The endpoint for the FPG analysis will be the mean of the week 20 and week 24 FPG values. All analyses (except the analysis of mean total daily dose of insulin) will utilize only observations at visits prior to rescue or where the subject's mean total daily dose of insulin has not increased by \\>10% from baseline. If an observation at week 24 is missing or does not meet these criteria, the latest post-baseline value that does will be carried forward (LOCF). The analysis of mean total daily dose of insulin will utilize the latest, non-missing, post-baseline value regardless of rescue. Multiplicity for the primary and secondary endpoints will be controlled via a hierarchical testing procedure that utilizes the full alpha (0.05) for each test. The sequence of testing will be: 1. Change from baseline in HbA1c at Week 24. 2. Change from baseline in PPG AUC at Week 24.3. Change from baseline in 120 minute PPG at Week 24. 4. Proportion of subjects achieving HbA1c \\<7.0% at Week 24. 5. Change from baseline in FPG to the mean at Week 20 and Week 24. 6. Change from baseline in MTDDI at Week 24."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of informed consent before participating in the study.\n2. Diagnosed with type 2 diabetes.\n3. Inadequate glycemic control (screening: HbA1c ≥7.5% and ≤11.0% and FPG\\<270 mg/dL (15mmol/L). At Day -4 visit, HbA1c ≥7.5% and ≤10.5%. and FPG\\<270 mg/dL (15mmol/L)).\n4. On a stable dose of insulin for 8 weeks or longer prior to screening.\n5. If taking metformin, subjects should have been taking the same daily dose for 8 weeks or longer prior to screening.\n6. Insulin type should be intermediate-acting or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as one component).\n7. Body mass index ≤45 kg/m\\^2.\n\nExclusion Criteria:\n\n1. Women of childbearing potential unable or unwilling to use acceptable birth control.\n2. Women who are pregnant or breastfeeding.\n3. Symptoms of poorly controlled diabetes. including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the last three months prior to screening or other signs and symptoms.\n4. Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable clinical significant arrhythmia, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.\n5. Congestive heart failure\n6. Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled).\n7. History of unstable or rapidly progressing renal disease.\n8. History of alcohol or drug abuse within the previous year.\n9. Unstable major psychiatric disorders.\n10. History of hemoglobinopathies\n11. Immunocompromised status\n12. Severe liver disease.\n13. In subjects treated with insulin alone a calculated creatinine clearance \\<50 ml/min. In patients treated with insulin in combination with metformin a calculated creatinine clearance \\<60 ml/min or serum creatinine \\> 1.5 mg/dL in males or \\> 1.4mg/dL in females.\n14. Anemia'}, 'identificationModule': {'nctId': 'NCT02104804', 'briefTitle': 'Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Chinese Subjects in China With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination With Metformin', 'orgStudyIdInfo': {'id': 'D1680C00010'}, 'secondaryIdInfos': [{'id': '2014L00001', 'type': 'OTHER', 'domain': 'China: State Food and Drug Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saxagliptin 5mg', 'description': 'Saxagliptin 5mg, administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin', 'interventionNames': ['Drug: Saxagliptin 5mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin', 'interventionNames': ['Drug: Placebo for Saxagliptin']}], 'interventions': [{'name': 'Saxagliptin 5mg', 'type': 'DRUG', 'otherNames': ['Insulin: intermediate-acting or basal or premixed ( include short- or rapid-acting insulin as one component). ≥20 unit/day, ≤150 units/day', 'Metformin: Glucophage, 500-2500mg/day'], 'description': 'Saxagliptin 5mg (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).', 'armGroupLabels': ['Saxagliptin 5mg']}, {'name': 'Placebo for Saxagliptin', 'type': 'DRUG', 'otherNames': ['Insulin: intermediate-acting or basal or premixed ( include short- or rapid-acting insulin as one component). ≥20 unit/day, ≤150 units/day', 'Metformin: Glucophage, 500-2500mg/day'], 'description': 'Placebo tablets (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Fuzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': "Ha'er Bing", 'country': 'China', 'facility': 'Research Site'}, {'city': 'Hefei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Nanchang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shijiazhuang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Shiyan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}], 'overallOfficials': [{'name': 'Linong Ji, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "People's Hospital of Peking Universty"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}