Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT00295633
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2006-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
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': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D000077154', 'term': 'Rosiglitazone'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Boaz Hirschberg', 'organization': 'AstraZeneca Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PLA + TZD', 'otherNumAtRisk': 184, 'otherNumAffected': 109, 'seriousNumAtRisk': 184, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'SAXA 2.5MG + TZD', 'otherNumAtRisk': 195, 'otherNumAffected': 107, 'seriousNumAtRisk': 195, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'SAXA 5MG + TZD', 'otherNumAtRisk': 186, 'otherNumAffected': 109, 'seriousNumAtRisk': 186, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 195, 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'EG001', 'numAtRisk': 195, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'MedDRA 11.1'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ALCOHOL ABUSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CEREBRAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CEREBELLAR HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CAROTID ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ANAL FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PANCREATITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'IRRITABLE BOWEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ORCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ANAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'MENINGITIS ASEPTIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'STAPHYLOCOCCAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RENAL CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CALCULUS BLADDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CALCULUS URETERIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HYPOVOLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 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0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PROSTATOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'POSTMENOPAUSAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BACK INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'LIMB INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'FIBULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'COLON NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'METASTATIC SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'OG002', 'title': 'Placebo Plus Open-label TZD', 'description': 'The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '8.25', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '8.35', 'spread': '0.080', 'groupId': 'OG001'}, {'value': '8.19', 'spread': '0.080', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 Mean', 'categories': [{'measurements': [{'value': '7.59', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '7.39', 'spread': '0.086', 'groupId': 'OG001'}, {'value': '7.91', 'spread': '0.100', 'groupId': 'OG002'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '0.075', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.076', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline in A1C at Week 24, adjusted for baseline value.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'OG002', 'title': 'Placebo Plus Open-label TZD', 'description': 'The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '163.0', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '159.5', 'spread': '3.34', 'groupId': 'OG001'}, {'value': '162.4', 'spread': '3.43', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 Mean', 'categories': [{'measurements': [{'value': '148.2', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '143.0', 'spread': '3.20', 'groupId': 'OG001'}, {'value': '159.3', 'spread': '4.29', 'groupId': 'OG002'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-14.3', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '-17.3', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '2.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline in FPG at Week 24, adjusted for baseline value.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving A1c <7% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'OG002', 'title': 'Placebo Plus Open-label TZD', 'description': 'The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}, {'value': '25.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "Percentage of participants achieving A1C \\< 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, subjects must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'OG002', 'title': 'Placebo Plus Open-label TZD', 'description': 'The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '48301', 'spread': '968.5', 'groupId': 'OG000'}, {'value': '47866', 'spread': '1048.9', 'groupId': 'OG001'}, {'value': '47256', 'spread': '1057.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 Mean', 'categories': [{'measurements': [{'value': '40255', 'spread': '919.7', 'groupId': 'OG000'}, {'value': '38587', 'spread': '991.3', 'groupId': 'OG001'}, {'value': '44819', 'spread': '1023.4', 'groupId': 'OG002'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-7849', 'spread': '740.6', 'groupId': 'OG000'}, {'value': '-9269', 'spread': '794.9', 'groupId': 'OG001'}, {'value': '-2690', 'spread': '820.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.', 'unitOfMeasure': 'mg*min/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. 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subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'BG001', 'title': 'Saxagliptin 5 mg Plus Open-label TZD', 'description': 'The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'BG002', 'title': 'Placebo Plus Open-label TZD', 'description': 'The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.85', 'spread': '9.73', 'groupId': 'BG000'}, {'value': '53.22', 'spread': '10.56', 'groupId': 'BG001'}, {'value': '54.01', 'spread': '10.08', 'groupId': 'BG002'}, {'value': '54.04', 'spread': '10.13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '285', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 565}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2006-02-22', 'resultsFirstSubmitDate': '2009-08-17', 'studyFirstSubmitQcDate': '2006-02-22', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-17', 'studyFirstPostDateStruct': {'date': '2006-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline in A1C at Week 24, adjusted for baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline in FPG at Week 24, adjusted for baseline value.'}, {'measure': 'Percentage of Participants Achieving A1c <7% at Week 24', 'timeFrame': 'Week 24', 'description': "Percentage of participants achieving A1C \\< 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24."}, {'measure': 'Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '19864452', 'type': 'BACKGROUND', 'citation': 'Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009 Dec;94(12):4810-9. doi: 10.1210/jc.2009-0550. Epub 2009 Oct 28.'}, {'pmid': '27402391', 'type': 'DERIVED', 'citation': 'Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.'}, {'pmid': '27033025', 'type': 'DERIVED', 'citation': 'Bonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.'}, {'pmid': '23795975', 'type': 'DERIVED', 'citation': 'Karyekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24.'}, {'pmid': '21680990', 'type': 'DERIVED', 'citation': 'Karyekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70. doi: 10.3810/pgm.2011.07.2305.'}, {'pmid': '21562064', 'type': 'DERIVED', 'citation': 'Hollander PL, Li J, Frederich R, Allen E, Chen R; CV181013 Investigators. Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2011 Apr;8(2):125-35. doi: 10.1177/1479164111404575.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone', 'detailedDescription': 'All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (defined as rescue medication) added onto their blinded study medication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.\n* Hemoglobin A1c (HbA1c) \\> = 7.0% and \\< = 10.5%\n* Body mass index \\< = 45kg/m2\n* Fasting C-peptide \\> = 1 ng/mL\n\nExclusion Criteria:\n\n* Symptomatic poorly controlled diabetes\n* Recent cardiac or cerebrovascular event\n* Serum creatinine \\> = 2.0 mg/dL'}, 'identificationModule': {'nctId': 'NCT00295633', 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PLUS pioglitazone OR rosiglitazone\n\nPLUS open-label metformin (as needed as rescue medication)', 'interventionNames': ['Drug: Saxagliptin', 'Drug: pioglitazone', 'Drug: rosiglitazone', 'Drug: metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus open-label TZD (C)', 'description': 'Placebo PLUS pioglitazone OR rosiglitazone\n\nPLUS open-label metformin (as needed as rescue medication)', 'interventionNames': ['Drug: Placebo', 'Drug: pioglitazone', 'Drug: rosiglitazone', 'Drug: metformin']}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['BMS-477118'], 'description': 'Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)', 'armGroupLabels': ['Saxagliptin plus open-label TZD (A)']}, {'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['BMS-477118'], 'description': 'Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)', 'armGroupLabels': ['Saxagliptin plus open-label TZD (B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)', 'armGroupLabels': ['Placebo plus open-label TZD (C)']}, {'name': 'pioglitazone', 'type': 'DRUG', 'description': 'Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)', 'armGroupLabels': ['Placebo plus open-label TZD (C)', 'Saxagliptin plus open-label TZD (A)', 'Saxagliptin plus open-label TZD (B)']}, {'name': 'rosiglitazone', 'type': 'DRUG', 'description': 'Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)', 'armGroupLabels': ['Placebo plus open-label TZD (C)', 'Saxagliptin plus open-label TZD (A)', 'Saxagliptin plus open-label TZD (B)']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'Tablets, Oral, 500-2500 mg, as needed (12 months LT)', 'armGroupLabels': ['Placebo plus open-label TZD (C)', 'Saxagliptin plus open-label TZD (A)', 'Saxagliptin plus open-label TZD (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35565', 'city': 'Haleyville', 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