Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT00121667
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2005-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin 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': 'D008687', 'term': 'Metformin'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).', 'otherNumAtRisk': 179, 'otherNumAffected': 129, 'seriousNumAtRisk': 179, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).', 'otherNumAtRisk': 181, 'otherNumAffected': 133, 'seriousNumAtRisk': 181, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).', 'otherNumAtRisk': 192, 'otherNumAffected': 139, 'seriousNumAtRisk': 192, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).', 'otherNumAtRisk': 191, 'otherNumAffected': 133, 'seriousNumAtRisk': 191, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIOGENIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SUPRAVENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CORONARY ARTERY INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VARICOSE VEIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MAJOR DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PSYCHIATRIC SYMPTOM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BILIARY COLIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PELVIC MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NEURILEMMOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUNG NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'UTERINE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MULTIPLE MYELOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "NON-HODGKIN'S LYMPHOMA", 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BREAST CANCER RECURRENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTROINTESTINAL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '8.08', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '8.07', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '7.98', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '8.06', 'spread': '0.07', 'groupId': 'OG003'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '0.13', 'spread': '0.07', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.53', 'pValueComment': 'Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'ANCOVA model: difference between week t and baseline values = baseline values + treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '-0.63', 'pValueComment': 'Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'ANCOVA model: difference between week t and baseline values = baseline values + treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.52', 'pValueComment': 'Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. 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Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.56', 'estimateComment': 'ANCOVA model: difference between week t and baseline values = baseline values + treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.28', 'ciLowerLimit': '-30.29', 'ciUpperLimit': '-16.27', 'pValueComment': 'Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.57', 'estimateComment': 'ANCOVA model: difference between week t and baseline values = baseline values + treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.74', 'ciLowerLimit': '-28.81', 'ciUpperLimit': '-14.68', 'pValueComment': 'Significance testing based on hierarchical testing. 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Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000'}, {'value': '43.5', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}, {'value': '16.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.5', 'ciLowerLimit': '10.6', 'ciUpperLimit': '30.5', 'pValueComment': 'Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.0', 'ciLowerLimit': '17.0', 'ciUpperLimit': '36.7', 'pValueComment': 'Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.9', 'ciLowerLimit': '17.7', 'ciUpperLimit': '37.7', 'pValueComment': 'Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '48224', 'spread': '869.70', 'groupId': 'OG000'}, {'value': '49021', 'spread': '876.17', 'groupId': 'OG001'}, {'value': '44931', 'spread': '889.85', 'groupId': 'OG002'}, {'value': '47407', 'spread': '1071.9', 'groupId': 'OG003'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-8891', 'spread': '797.97', 'groupId': 'OG000'}, {'value': '-9586', 'spread': '810.46', 'groupId': 'OG001'}, {'value': '-8137', 'spread': '807.88', 'groupId': 'OG002'}, {'value': '-3291', 'spread': '853.24', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5599', 'ciLowerLimit': '-7894', 'ciUpperLimit': '-3305', 'pValueComment': 'Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1168.2', 'estimateComment': 'ANCOVA model: difference between week t and baseline values = baseline values + treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6294', 'ciLowerLimit': '-8606', 'ciUpperLimit': '-3983', 'pValueComment': 'Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1176.8', 'estimateComment': 'ANCOVA model: difference between week t and baseline values = baseline values + treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4845', 'ciLowerLimit': '-7153', 'ciUpperLimit': '-2537', 'pValueComment': 'Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1175.1', 'estimateComment': 'ANCOVA model: difference between week t and baseline values = baseline values + treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline is adjusted for baseline value.', 'unitOfMeasure': 'mg*min/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Summary of Adverse Events During ST+LT Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'At Least 1 AE', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}]}, {'title': 'At Least 1 Related AE', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'At Least 1 SAE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'At Least 1 Related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Discontinuations Due to SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Discontinuations Due to AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Marked Laboratory Abnormalities - During ST + LT Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Hemoglobin < 8 g/dL (n=189, 190, 181, 179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hematocrit < 0.75 x pre-Rx (n=189, 190, 181, 179)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Platelets < 50 x 10^9 c/L (n=189, 188, 181, 178)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelets > 1.5 x ULN (n=189, 188, 181, 178)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes < 2 x 1000 c/µL (n=189, 190, 181, 179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils+Bands <1x1000 c/µL (n=189,190,181,179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils >0.9x1000 c/µL (n=189, 190, 181, 179)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes <=0.75x1000 c/µL (n=189,190,181,179)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'ALP >3 x pre-Rx and >ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALP >1.5 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'AST >3 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AST >5 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AST >10 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AST >20 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT >3 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT >5 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT >10 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT >20 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin Total >2mg/dL (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin Total >1.5xULN (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin Total >2xULN (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'BUN >2 x pre-Rx and >ULN (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine >2.5 mg/dL (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Glucose, Plasma Fasting<50mg/dL(n=189,189,181,179)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Glucose,Plasma Fasting>500mg/dL(n=189,189,181,179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Glucose, Plasma Unspec.<50mg/dL(n=192,191,181,179)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Glucose,Plasma Unspec.>500mg/dL(n=192,191,181,179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Sodium,Serum Low (*) (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Sodium,Serum High (*) (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Potassium, Serum Low (*) (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Potassium, Serum High (n=190,190,181,179)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Chloride < 90 mEq/L (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Chloride > 120 mEq/L (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Albumin < 0.9 LLN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatine Kinase > 5 x ULN (n=190, 190, 181, 179)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Uric Acid > 1.5 x ULN (n=0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Protein Urine, >=2-4 (n=187, 189, 180, 178)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Blood Urine, >=2-4 (n=187, 189, 180, 178)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Red Blood Cells Urine >=2-4 (n=175,176,162,166)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'White Blood Cells Urine >=2-4 (n=175,176,162,166)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.', 'description': 'A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: \\<0.9 x Pre-Rx \\& \\<=130mEq/L / high: \\>1.1 x Pre-Rx \\& \\>=150mEq/L; potassium, serum low: \\<=0.8 x Pre-Rx \\& \\>=6.0mEq/L / high: 1.2 x Pre-Rx \\& \\>=6.0mEq/L; LLN=lower limit of normal.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (BL) (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '14.06', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '14.18', 'spread': '0.094', 'groupId': 'OG001'}, {'value': '14.18', 'spread': '0.103', 'groupId': 'OG002'}, {'value': '13.99', 'spread': '0.096', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=181, 177, 172, 169)', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.052', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.044', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '0.046', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=178, 178, 174, 166)', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.053', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.056', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=176, 174, 166, 160)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.050', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.050', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.055', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=173, 176, 165, 157)', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.051', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.055', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.056', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=149, 134, 137, 131)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.057', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.067', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '0.064', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=170, 167, 160, 144)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.054', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.055', 'groupId': 'OG002'}, {'value': '-0.05', 'spread': '0.065', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 154, 146, 139)', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.055', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.068', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '0.066', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=167, 166, 159, 140)', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.052', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.060', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.060', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 158, 149, 141)', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.050', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.059', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '0.062', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 147)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.061', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.060', 'groupId': 'OG002'}, {'value': '-0.12', 'spread': '0.060', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 152, 143, 138)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.063', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.062', 'groupId': 'OG002'}, {'value': '-0.23', 'spread': '0.065', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=164, 160, 159, 137)', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.063', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.057', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '0.065', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=161, 155, 154, 137)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.063', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.071', 'groupId': 'OG002'}, {'value': '-0.18', 'spread': '0.065', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=152, 149, 146, 122)', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.064', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.067', 'groupId': 'OG002'}, {'value': '-0.17', 'spread': '0.066', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=151, 142, 146, 127)', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.070', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.066', 'groupId': 'OG002'}, {'value': '-0.12', 'spread': '0.077', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=148, 137, 142, 116)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.067', 'groupId': 'OG002'}, {'value': '-0.07', 'spread': '0.073', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.080', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.066', 'groupId': 'OG002'}, {'value': '-0.26', 'spread': '0.083', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=123, 114, 123, 85)', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.075', 'groupId': 'OG001'}, {'value': '-0.32', 'spread': '0.083', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '0.088', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=108, 104, 112, 70)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.085', 'groupId': 'OG001'}, {'value': '-0.27', 'spread': '0.078', 'groupId': 'OG002'}, {'value': '-0.34', 'spread': '0.100', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=99, 94, 98, 58)', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '0.092', 'groupId': 'OG002'}, {'value': '-0.26', 'spread': '0.106', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=92, 88, 90, 52)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '0.095', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '0.105', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 79, 85, 48)', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.104', 'groupId': 'OG002'}, {'value': '-0.45', 'spread': '0.132', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=81, 74, 78, 45)', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.102', 'groupId': 'OG002'}, {'value': '-0.57', 'spread': '0.107', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=77, 67, 75, 42)', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.119', 'groupId': 'OG002'}, {'value': '-0.51', 'spread': '0.137', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=70, 61, 73, 41)', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.154', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '-0.53', 'spread': '0.129', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=70, 60, 72, 40)', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.159', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.101', 'groupId': 'OG002'}, {'value': '-0.53', 'spread': '0.134', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 50, 64, 31)', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.135', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '0.101', 'groupId': 'OG002'}, {'value': '-0.75', 'spread': '0.125', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Hematocrit During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '41.9', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '42.2', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '41.8', 'spread': '0.28', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=181, 177, 172, 169)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=178, 178, 174, 166)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=176, 174, 166, 160)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=173, 176, 165, 157)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=149, 134, 137, 131)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.20', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=170, 167, 160, 144)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.20', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 154, 146, 139)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.20', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=167, 166, 159, 140)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 158, 149, 141)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.21', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 147)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.20', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 152, 143, 138)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.23', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=164, 160, 159, 137)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.22', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=161, 155, 154, 137)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.23', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=152, 149, 146, 122)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.21', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=151, 142, 146, 127)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.25', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=148, 137, 142, 116)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.24', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.28', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=123, 114, 123, 85)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.29', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=108, 104, 112, 70)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.31', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=99, 94, 98, 58)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.33', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=92, 88, 90, 52)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.34', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 79, 85, 48)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.31', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '0.37', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=81, 74, 78, 45)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.34', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=77, 67, 75, 42)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '0.41', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=70, 61, 73, 41)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '0.34', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=70, 60, 72, 40)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.42', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 50, 64, 31)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '0.48', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': 'percentage red blood cells', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '4.68', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '4.70', 'spread': '0.034', 'groupId': 'OG002'}, {'value': '4.66', 'spread': '0.033', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=181, 177, 172, 169)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.015', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=178, 178, 174, 166)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.019', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.018', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=176, 174, 166, 160)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.017', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=173, 176, 165, 157)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.019', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.019', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=149, 134, 137, 131)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.019', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.022', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=170, 167, 160, 144)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.020', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.022', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 154, 146, 139)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.024', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.022', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=167, 166, 159, 140)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '0.020', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 158, 149, 141)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.021', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 147)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.020', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.021', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 152, 143, 138)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.020', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '0.023', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=164, 160, 159, 137)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.019', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.024', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=161, 155, 154, 137)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.022', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.021', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=152, 149, 146, 122)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.019', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.022', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=151, 142, 146, 127)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.024', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=148, 137, 142, 116)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.023', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '0.024', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.023', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '0.029', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=123, 114, 123, 85)', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.030', 'groupId': 'OG002'}, {'value': '-0.07', 'spread': '0.028', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=108, 104, 112, 70)', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.027', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '0.031', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=99, 94, 98, 58)', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.027', 'groupId': 'OG002'}, {'value': '-0.11', 'spread': '0.034', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=92, 88, 90, 52)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.030', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.027', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '0.031', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 79, 85, 48)', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.031', 'groupId': 'OG002'}, {'value': '-0.13', 'spread': '0.041', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=81, 74, 78, 45)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.029', 'groupId': 'OG002'}, {'value': '-0.20', 'spread': '0.035', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=77, 67, 75, 42)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.032', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.034', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '0.041', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=70, 61, 73, 41)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.033', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '0.037', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=70, 60, 72, 40)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.032', 'groupId': 'OG002'}, {'value': '-0.13', 'spread': '0.044', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 50, 64, 31)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.032', 'groupId': 'OG002'}, {'value': '-0.15', 'spread': '0.048', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': '10^6 c/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 189, 181, 178)', 'categories': [{'measurements': [{'value': '265.5', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '256.2', 'spread': '4.28', 'groupId': 'OG001'}, {'value': '258.7', 'spread': '5.05', 'groupId': 'OG002'}, {'value': '261.0', 'spread': '5.05', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=179, 168, 167, 166)', 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '2.57', 'groupId': 'OG002'}, {'value': '13.7', 'spread': '2.99', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=176, 172, 168, 164)', 'categories': [{'measurements': [{'value': '11.3', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '11.1', 'spread': '3.04', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=171, 171, 164, 157)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '2.78', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '4.16', 'groupId': 'OG002'}, {'value': '12.0', 'spread': '2.99', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=172, 170, 162, 151)', 'categories': [{'measurements': [{'value': '6.7', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '2.67', 'groupId': 'OG002'}, {'value': '8.5', 'spread': '3.07', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=147, 132, 137, 129)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '3.24', 'groupId': 'OG002'}, {'value': '11.5', 'spread': '3.30', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=170, 165, 157, 141)', 'categories': [{'measurements': [{'value': '6.8', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '3.24', 'groupId': 'OG002'}, {'value': '8.2', 'spread': '2.83', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=153, 149, 145, 133)', 'categories': [{'measurements': [{'value': '6.1', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '3.08', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '2.70', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 161, 156, 133)', 'categories': [{'measurements': [{'value': '5.3', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '3.15', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=152, 155, 147, 139)', 'categories': [{'measurements': [{'value': '5.6', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '2.82', 'groupId': 'OG002'}, {'value': '8.5', 'spread': '3.59', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=160, 151, 153, 144)', 'categories': [{'measurements': [{'value': '4.9', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '3.07', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '3.06', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=151, 148, 142, 134)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '2.98', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '2.95', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '3.24', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=158, 153, 156, 135)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '2.75', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '2.95', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=157, 153, 148, 130)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.88', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '3.18', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '3.65', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=149, 142, 139, 120)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '3.16', 'groupId': 'OG001'}, {'value': '-11.9', 'spread': '2.98', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '3.84', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=151, 141, 143, 120)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '3.44', 'groupId': 'OG001'}, {'value': '-9.0', 'spread': '3.13', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '3.70', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=147, 132, 137, 115)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '3.36', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '4.80', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '4.15', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=132, 124, 130, 92)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '3.84', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.55', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '3.09', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '3.98', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=122, 111, 122, 84)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '3.68', 'groupId': 'OG002'}, {'value': '13.6', 'spread': '3.91', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=107, 103, 110, 69)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '3.47', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '3.74', 'groupId': 'OG002'}, {'value': '6.1', 'spread': '5.20', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=99, 93, 98, 57)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '4.12', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '4.19', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '5.12', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=91, 84, 88, 51)', 'categories': [{'measurements': [{'value': '5.7', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '3.89', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '4.41', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '4.73', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=83, 77, 84, 47)', 'categories': [{'measurements': [{'value': '9.2', 'spread': '4.96', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '4.45', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '5.21', 'groupId': 'OG002'}, {'value': '12.0', 'spread': '5.24', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=79, 70, 77, 45)', 'categories': [{'measurements': [{'value': '8.0', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '4.55', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '5.79', 'groupId': 'OG002'}, {'value': '12.5', 'spread': '7.01', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=75, 64, 74, 41)', 'categories': [{'measurements': [{'value': '10.1', 'spread': '5.39', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '4.39', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '5.26', 'groupId': 'OG002'}, {'value': '13.8', 'spread': '6.78', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=68, 60, 71, 41)', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '5.65', 'groupId': 'OG001'}, {'value': '-8.3', 'spread': '5.07', 'groupId': 'OG002'}, {'value': '8.9', 'spread': '5.80', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=67, 57, 68, 40)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '6.40', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '5.40', 'groupId': 'OG001'}, {'value': '-8.5', 'spread': '5.19', 'groupId': 'OG002'}, {'value': '12.2', 'spread': '6.79', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 49, 64, 31)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '6.45', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '7.48', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '5.62', 'groupId': 'OG002'}, {'value': '9.8', 'spread': '7.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': '10^9 c/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '7.23', 'spread': '0.136', 'groupId': 'OG000'}, {'value': '7.25', 'spread': '0.167', 'groupId': 'OG001'}, {'value': '7.12', 'spread': '0.136', 'groupId': 'OG002'}, {'value': '7.19', 'spread': '0.136', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=178, 175, 171, 169)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.116', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.102', 'groupId': 'OG002'}, {'value': '0.11', 'spread': '0.113', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=176, 176, 171, 166)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.131', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.100', 'groupId': 'OG002'}, {'value': '0.22', 'spread': '0.117', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=175, 172, 165, 158)', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.102', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.092', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.115', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=172, 174, 163, 153)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.104', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.116', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.106', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.109', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=148, 130, 137, 128)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.126', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '0.39', 'spread': '0.115', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=169, 166, 159, 142)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.134', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.114', 'groupId': 'OG002'}, {'value': '0.37', 'spread': '0.130', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 152, 145, 136)', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.148', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.121', 'groupId': 'OG002'}, {'value': '0.33', 'spread': '0.132', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 166, 159, 137)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '0.115', 'groupId': 'OG002'}, {'value': '0.42', 'spread': '0.139', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 158, 149, 139)', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.121', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.135', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.114', 'groupId': 'OG002'}, {'value': '0.58', 'spread': '0.135', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 146)', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.130', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.111', 'groupId': 'OG002'}, {'value': '0.39', 'spread': '0.142', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 152, 143, 138)', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.138', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.112', 'groupId': 'OG002'}, {'value': '0.50', 'spread': '0.120', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=162, 160, 157, 135)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.161', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.097', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.135', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=160, 155, 154, 136)', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.131', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.109', 'groupId': 'OG002'}, {'value': '0.14', 'spread': '0.141', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=150, 149, 146, 121)', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.137', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.135', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=150, 142, 145, 125)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.160', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '0.114', 'groupId': 'OG002'}, {'value': '-0.36', 'spread': '0.120', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=147, 136, 140, 115)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.117', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.123', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.168', 'groupId': 'OG002'}, {'value': '-0.39', 'spread': '0.148', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.122', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.157', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '-0.30', 'spread': '0.172', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=122, 114, 123, 85)', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.136', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.153', 'groupId': 'OG002'}, {'value': '-0.38', 'spread': '0.197', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=105, 104, 111, 68)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.150', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '0.102', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '0.178', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=98, 92, 95, 57)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.161', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.183', 'groupId': 'OG002'}, {'value': '-0.15', 'spread': '0.202', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=90, 87, 88, 50)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.148', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.155', 'groupId': 'OG002'}, {'value': '-0.32', 'spread': '0.225', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 78, 85, 47)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.161', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.174', 'groupId': 'OG002'}, {'value': '-0.07', 'spread': '0.235', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=77, 72, 78, 45)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.226', 'groupId': 'OG001'}, {'value': '-0.55', 'spread': '0.144', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '0.180', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=76, 67, 75, 42)', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.179', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.178', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.152', 'groupId': 'OG002'}, {'value': '-0.38', 'spread': '0.177', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=70, 60, 72, 41)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.212', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '0.142', 'groupId': 'OG002'}, {'value': '-0.37', 'spread': '0.190', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=69, 60, 72, 40)', 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.160', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.228', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.143', 'groupId': 'OG002'}, {'value': '-0.35', 'spread': '0.203', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 49, 63, 31)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.175', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.270', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '0.170', 'groupId': 'OG002'}, {'value': '-0.71', 'spread': '0.201', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': '10^3 c/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '4.27', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '4.19', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '4.23', 'spread': '0.102', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=178, 175, 170, 169)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.102', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.087', 'groupId': 'OG002'}, {'value': '0.12', 'spread': '0.094', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=176, 175, 170, 166)', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.116', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.098', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=175, 172, 165, 158)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.075', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '0.085', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.098', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=172, 172, 163, 153)', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.103', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.096', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.097', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=148, 130, 137, 128)', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.106', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.105', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=168, 166, 159, 141)', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.110', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.102', 'groupId': 'OG002'}, {'value': '0.27', 'spread': '0.111', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 152, 145, 136)', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.125', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.109', 'groupId': 'OG002'}, {'value': '0.17', 'spread': '0.112', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 166, 157, 137)', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '0.33', 'spread': '0.113', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 157, 149, 139)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.104', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.116', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.099', 'groupId': 'OG002'}, {'value': '0.34', 'spread': '0.111', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 146)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.099', 'groupId': 'OG002'}, {'value': '0.24', 'spread': '0.122', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 151, 143, 138)', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.116', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.097', 'groupId': 'OG002'}, {'value': '0.24', 'spread': '0.100', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=162, 160, 157, 135)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.088', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.150', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '0.091', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.111', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=159, 155, 154, 136)', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.117', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.111', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=150, 149, 146, 121)', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '0.096', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '0.105', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=150, 142, 145, 124)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.104', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.144', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '0.105', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=147, 136, 140, 115)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.100', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.140', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '0.119', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.133', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.101', 'groupId': 'OG002'}, {'value': '-0.13', 'spread': '0.146', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=122, 113, 123, 85)', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.121', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.106', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.132', 'groupId': 'OG002'}, {'value': '-0.18', 'spread': '0.163', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=104, 104, 111, 68)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '-0.35', 'spread': '0.142', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=98, 92, 95, 57)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.145', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.167', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.169', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=90, 87, 88, 50)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.147', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.111', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.136', 'groupId': 'OG002'}, {'value': '-0.11', 'spread': '0.185', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 78, 84, 47)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.128', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.131', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.151', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.195', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=77, 71, 78, 45)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.167', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.194', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '0.117', 'groupId': 'OG002'}, {'value': '-0.34', 'spread': '0.137', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=76, 67, 75, 42)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.160', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.130', 'groupId': 'OG002'}, {'value': '-0.22', 'spread': '0.145', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=69, 60, 72, 41)', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.159', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.176', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.114', 'groupId': 'OG002'}, {'value': '-0.20', 'spread': '0.155', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=69, 60, 71, 40)', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.178', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.118', 'groupId': 'OG002'}, {'value': '-0.19', 'spread': '0.185', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 48, 63, 31)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.146', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.215', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.124', 'groupId': 'OG002'}, {'value': '-0.29', 'spread': '0.154', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': '10^3 c/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '2.29', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '0.057', 'groupId': 'OG001'}, {'value': '2.23', 'spread': '0.051', 'groupId': 'OG002'}, {'value': '2.31', 'spread': '0.054', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=178, 175, 170, 169)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.036', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.038', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '0.038', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=176, 175, 170, 166)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.037', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.035', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.037', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=175, 172, 165, 158)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.033', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.037', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.038', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=172, 172, 163, 153)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.039', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.038', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.044', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=148, 130, 137, 128)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.049', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.051', 'groupId': 'OG002'}, {'value': '0.15', 'spread': '0.046', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=168, 166, 159, 141)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.041', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.043', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.045', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 152, 145, 136)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.039', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.044', 'groupId': 'OG002'}, {'value': '0.11', 'spread': '0.048', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 166, 157, 137)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.047', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.051', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 157, 149, 139)', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.048', 'groupId': 'OG002'}, {'value': '0.14', 'spread': '0.050', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 146)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.039', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.052', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 151, 143, 138)', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.044', 'groupId': 'OG002'}, {'value': '0.18', 'spread': '0.047', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=162, 160, 157, 135)', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.039', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.051', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=159, 155, 154, 136)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.048', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.051', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=150, 149, 146, 121)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.048', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.051', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=150, 142, 145, 124)', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.044', 'groupId': 'OG002'}, {'value': '-0.10', 'spread': '0.042', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=147, 136, 140, 115)', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.042', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '0.051', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.046', 'groupId': 'OG002'}, {'value': '-0.17', 'spread': '0.054', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=122, 114, 123, 85)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.053', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.062', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '0.047', 'groupId': 'OG002'}, {'value': '-0.21', 'spread': '0.061', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=104, 104, 111, 68)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.058', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.044', 'groupId': 'OG002'}, {'value': '-0.20', 'spread': '0.063', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=98, 92, 95, 58)', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.056', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '0.057', 'groupId': 'OG002'}, {'value': '-0.12', 'spread': '0.065', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=91, 88, 88, 50)', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.057', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '0.053', 'groupId': 'OG002'}, {'value': '-0.21', 'spread': '0.075', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 78, 84, 48)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.058', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.060', 'groupId': 'OG002'}, {'value': '-0.17', 'spread': '0.080', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=78, 71, 78, 45)', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.079', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.075', 'groupId': 'OG002'}, {'value': '-0.19', 'spread': '0.065', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=77, 67, 75, 42)', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.058', 'groupId': 'OG002'}, {'value': '-0.13', 'spread': '0.072', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=69, 60, 72, 41)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.072', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.074', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '0.081', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=69, 60, 71, 40)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.071', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '0.079', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 48, 63, 31)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.085', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '0.067', 'groupId': 'OG002'}, {'value': '-0.32', 'spread': '0.077', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': '10^3 c/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.014', 'groupId': 'OG002'}, {'value': '0.40', 'spread': '0.014', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=178, 175, 170, 169)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.012', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.011', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=176, 175, 170, 166)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.012', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=175, 172, 165, 158)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.015', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=172, 172, 163, 153)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=148, 130, 137, 128)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.014', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=168, 166, 159, 141)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.014', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 152, 145, 136)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.014', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 166, 157, 137)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.014', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 157, 149, 139)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.014', 'groupId': 'OG002'}, {'value': '0.06', 'spread': '0.014', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 146)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.012', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 151, 143, 138)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=162, 160, 157, 135)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=159, 155, 154, 136)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.018', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=150, 149, 146, 121)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.016', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=150, 142, 145, 124)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=147, 136, 140, 115)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.019', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.015', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.015', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=122, 113, 123, 85)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.019', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.016', 'groupId': 'OG002'}, {'value': '0.06', 'spread': '0.017', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=104, 104, 111, 68)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '0.06', 'spread': '0.018', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=98, 92, 95, 57)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.017', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.019', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=90, 87, 88, 50)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.014', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.020', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 78, 84, 47)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.019', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=77, 71, 78, 45)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.025', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.019', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.019', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=76, 67, 75, 42)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.017', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.017', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=69, 60, 72, 41)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.017', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.016', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=69, 60, 71, 40)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.017', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.014', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 48, 63, 31)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.019', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.016', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': '10^3 c/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=178, 175, 170, 169)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=176, 175, 170, 166)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=175, 172, 165, 158)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=172, 172, 163, 153)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=148, 130, 137, 128)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.004', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=168, 166, 159, 141)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 152, 145, 136)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 166, 157, 137)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 157, 149, 139)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 146)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.004', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 151, 143, 138)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.005', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=162, 160, 157, 135)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.004', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=159, 155, 154, 136)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=150, 149, 146, 121)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.004', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=150, 142, 145, 124)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=147, 136, 140, 115)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.005', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.005', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.005', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=122, 113, 123, 85)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.005', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=104, 104, 111, 68)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.005', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.005', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.006', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=98, 92, 95, 57)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.004', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.007', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=90, 87, 88, 50)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.005', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.005', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.008', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 78, 84, 47)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.008', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=77, 71, 78, 45)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.005', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.005', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.007', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=76, 67, 75, 42)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.005', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.008', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=69, 60, 72, 41)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.004', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.006', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=69, 60, 71, 40)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.004', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.008', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 48, 63, 31)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.005', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.008', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': '10^3 c/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Baseline (Week 0) (n=192, 191, 181, 179)', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.024', 'groupId': 'OG002'}, {'value': '0.21', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 2 (n=178, 175, 170, 169)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.010', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.007', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=176, 175, 170, 166)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.011', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.016', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.007', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=175, 172, 165, 158)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.012', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.009', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=172, 172, 163, 153)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.011', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.010', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=148, 130, 137, 128)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.019', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.011', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=168, 166, 159, 141)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.009', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=156, 152, 145, 136)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.016', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 166, 157, 137)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.012', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.014', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.016', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=155, 157, 149, 139)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.015', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=162, 153, 154, 146)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.013', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=157, 151, 143, 138)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.014', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=162, 160, 157, 135)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.011', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=159, 155, 154, 136)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.012', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.012', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=150, 149, 146, 121)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.011', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=150, 142, 145, 124)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.030', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '0.011', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=147, 136, 140, 115)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.015', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 130, 94)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.014', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.015', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=122, 113, 123, 85)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.015', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=104, 104, 111, 68)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.018', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=98, 92, 95, 57)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.025', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.022', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=90, 87, 88, 50)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.021', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=85, 78, 84, 47)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.032', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=77, 71, 78, 45)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.020', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=76, 67, 75, 42)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.020', 'groupId': 'OG002'}, {'value': '-0.05', 'spread': '0.019', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=69, 60, 72, 41)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.017', 'groupId': 'OG002'}, {'value': '-0.04', 'spread': '0.023', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=69, 60, 71, 40)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.023', 'groupId': 'OG002'}, {'value': '-0.04', 'spread': '0.025', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 48, 63, 31)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.031', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '0.028', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': '10^3 c/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Systolic Blood Pressure During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Change from BL at Week 2 (n=182, 181, 176, 170)', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=178, 179, 175, 164)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=178, 176, 171, 162)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=175, 176, 170, 152)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=116, 108, 101, 101)', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '-6.8', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=170, 166, 161, 138)', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=132, 129, 124, 116)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 164, 156, 140)', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=144, 141, 132, 123)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=163, 155, 153, 147)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=146, 140, 136, 126)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=165, 160, 161, 140)', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-4.5', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=162, 156, 155, 138)', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=154, 151, 149, 123)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=155, 147, 151, 130)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=151, 138, 145, 117)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 133, 98)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=124, 117, 125, 86)', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=111, 107, 113, 73)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=100, 94, 98, 58)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=94, 88, 90, 52)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=87, 82, 85, 49)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '2.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=84, 75, 79, 45)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '2.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=78, 67, 75, 42)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '2.5', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=71, 63, 74, 41)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '2.5', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=70, 60, 72, 40)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '2.4', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 53, 64, 33)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '2.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Change from BL at Week 2 (n=182, 181, 176, 170)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=178, 179, 175, 164)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=178, 176, 171, 162)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=175, 176, 170, 152)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=116, 108, 101, 101)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=170, 166, 161, 138)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=132, 129, 124, 116)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 164, 156, 140)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=144, 141, 132, 123)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=163, 155, 153, 147)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-1.9', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=146, 140, 136, 126)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=165, 160, 161, 140)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=162, 156, 155, 138)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=154, 151, 149, 123)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=155, 147, 151, 130)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=151, 138, 145, 117)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 133, 98)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '1.0', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=124, 117, 125, 86)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '1.0', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=111, 107, 113, 73)', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=100, 94, 98, 58)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=94, 88, 90, 52)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=87, 82, 85, 49)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=84, 75, 79, 45)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=78, 67, 75, 42)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=71, 63, 74, 41)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=70, 60, 72, 40)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 53, 64, 33)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '1.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Heart Rate During the ST + LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Change from BL at Week 2 (n=182, 181, 176, 170)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 4 (n=178, 179, 175, 164)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 6 (n=178, 176, 171, 162)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 8 (n=175, 176, 170, 152)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 10 (n=116, 106, 100, 101)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 12 (n=170, 166, 161, 138)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 14 (n=132, 129, 124, 116)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 16 (n=166, 164, 156, 140)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 18 (n=144, 141, 132, 123)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 20 (n=163, 155, 153, 147)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 22 (n=146, 140, 136, 126)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 24 (n=165, 160, 161, 140)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 30 (n=162, 156, 154, 138)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 37 (n=154, 151, 149, 123)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 50 (n=154, 147, 151, 130)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 63 (n=151, 138, 145, 117)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 76 (n=134, 126, 133, 98)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 89 (n=124, 116, 125, 86)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '1.0', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 102 (n=111, 107, 113, 73)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 115 (n=100, 94, 98, 58)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 128 (n=94, 88, 90, 52)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 141 (n=87, 82, 85, 49)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 154 (n=84, 75, 79, 45)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 167 (n=78, 67, 75, 42)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 180 (n=71, 63, 74, 41)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 193 (n=70, 60, 72, 40)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Change from BL at Week 206 (n=61, 53, 64, 33)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '1.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; n=number of treated participants with measurement at time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'title': 'Normal BL, Normal Week 12(BL n=108, 109, 104, 104)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Abnormal Week 12 (BL n=108,109,104,104)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Normal Week 12 (BL n=69, 66, 70, 58)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Abnormal Week 12(BL n=69, 66, 70, 58)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Normal Week 24 (BL n=96, 87, 83, 77)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Abnormal Week 24 (BL n=96, 87, 83, 77)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Normal Week 24 (BL n=58, 58, 56, 41)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Abnormal Week 24(BL n=58, 58, 56, 41)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Normal Week 76 (BL n=94, 89, 92, 81)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Abnormal Week 76 (BL n=94, 89, 92, 81)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Normal Week 76 (BL n=51, 52, 59, 44)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Abnormal Week 76 (BL n=51,52,59,44)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Normal Week 102 (BL n=80, 66, 65, 50)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Abnormal Week 102 (BL n=80, 66, 65, 50)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Normal Week 102 (BL n=43,45,49, 21)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Abnormal Week 102 (BL n=43,45,49, 21)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Normal Week 154 (BL n=60, 46, 53, 34)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Abnormal Week 154 (BL n=60, 46, 53, 34)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Normal Week 154 (BL n=26, 34, 34, 16)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Abnormal Week 154 (BL n=26,34,34,16)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Normal Week 206 (BL n=48, 31, 42, 24)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Normal BL, Abnormal Week 206 (BL n=48, 31, 42, 24)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Normal Week 206 (BL n=20, 25, 28, 13)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal BL, Abnormal Week 206 (BL n=20,25,28,13)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 24, 76, 102, 154, 206,', 'description': 'The normality/abnormality of the ECG tracing was determined by the investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed=Treated Participants; BL n=normal or abnormal ECG status at baseline of the cohort of participants with measure at given time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla', 'description': 'Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Confirmed Hypoglycemia During the ST + LT Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'OG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla', 'description': "'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose \\<= 50 mg/dL and associated symptoms.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'FG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'FG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'FG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}], 'periods': [{'title': 'Short Term (ST) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '191'}, {'groupId': 'FG002', 'numSubjects': '181'}, {'groupId': 'FG003', 'numSubjects': '179'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '143'}, {'groupId': 'FG002', 'numSubjects': '140'}, {'groupId': 'FG003', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '67'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Poor / Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Subject No Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Short Term (ST) + Long Term (LT) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '191'}, {'groupId': 'FG002', 'numSubjects': '181'}, {'groupId': 'FG003', 'numSubjects': '179'}]}, {'type': 'Completed Study Without Being Rescued', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '133'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '140'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Subject No Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Poor / Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '1462 participants were enrolled, and 787 entered the lead-in period. 45 discontinued the during the lead-in period. 19 subjects no longer met study criteria, 10 subjects withdrew consent, and 2 subjects were randomized but not treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}, {'value': '743', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Saxagliptin 2.5 mg + Metformin', 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'BG001', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'BG002', 'title': 'Saxagliptin 10 mg + Metformin', 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'BG003', 'title': 'Placebo+ Metformin', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.66', 'spread': '10.08', 'groupId': 'BG000'}, {'value': '54.69', 'spread': '9.62', 'groupId': 'BG001'}, {'value': '54.18', 'spread': '10.14', 'groupId': 'BG002'}, {'value': '54.76', 'spread': '10.18', 'groupId': 'BG003'}, {'value': '54.57', 'spread': '9.98', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}, {'value': '626', 'groupId': 'BG004'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '366', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '377', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '606', 'groupId': 'BG004'}]}]}, {'title': 'Black / African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic / Latino', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic / Latino', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '229', 'groupId': 'BG004'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '406', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age Characterization Female Only', 'classes': [{'title': '=< 50 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}]}, {'title': '> 50 years', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '254', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '85.97', 'spread': '17.57', 'groupId': 'BG000'}, {'value': '87.26', 'spread': '17.04', 'groupId': 'BG001'}, {'value': '87.83', 'spread': '18.90', 'groupId': 'BG002'}, {'value': '87.14', 'spread': '17.75', 'groupId': 'BG003'}, {'value': '87.04', 'spread': '17.79', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.68', 'spread': '5.15', 'groupId': 'BG000'}, {'value': '31.23', 'spread': '4.67', 'groupId': 'BG001'}, {'value': '31.12', 'spread': '4.79', 'groupId': 'BG002'}, {'value': '31.57', 'spread': '4.80', 'groupId': 'BG003'}, {'value': '31.40', 'spread': '4.85', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index Categorization', 'classes': [{'title': '< 30', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '317', 'groupId': 'BG004'}]}]}, {'title': '>= 30', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '426', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', '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': 1462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'dispFirstSubmitDate': '2009-07-30', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2005-07-18', 'dispFirstSubmitQcDate': '2010-08-13', 'resultsFirstSubmitDate': '2011-03-15', 'studyFirstSubmitQcDate': '2005-07-20', 'dispFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-15', 'studyFirstPostDateStruct': {'date': '2005-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Summary of Adverse Events During ST+LT Treatment Period', 'timeFrame': 'AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.'}, {'measure': 'Marked Laboratory Abnormalities - During ST + LT Treatment Period', 'timeFrame': 'Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.', 'description': 'A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: \\<0.9 x Pre-Rx \\& \\<=130mEq/L / high: \\>1.1 x Pre-Rx \\& \\>=150mEq/L; potassium, serum low: \\<=0.8 x Pre-Rx \\& \\>=6.0mEq/L / high: 1.2 x Pre-Rx \\& \\>=6.0mEq/L; LLN=lower limit of normal.'}, {'measure': 'Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in Hematocrit During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period', 'timeFrame': 'Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Changes From Baseline in Systolic Blood Pressure During the ST + LT Period', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Changes From Baseline in Heart Rate During the ST + LT Period', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206'}, {'measure': 'Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period', 'timeFrame': 'Baseline, Weeks 12, 24, 76, 102, 154, 206,', 'description': 'The normality/abnormality of the ECG tracing was determined by the investigator.'}, {'measure': 'All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period', 'timeFrame': 'AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla', 'description': 'Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.'}, {'measure': 'Confirmed Hypoglycemia During the ST + LT Treatment Period', 'timeFrame': 'AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla', 'description': "'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose \\<= 50 mg/dL and associated symptoms."}], 'primaryOutcomes': [{'measure': 'Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline is adjusted for baseline value.'}], 'secondaryOutcomes': [{'measure': 'Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline is adjusted for baseline value.'}, {'measure': 'Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean change from baseline is adjusted for baseline value.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '19478198', 'type': 'BACKGROUND', 'citation': 'DeFronzo RA, Hissa MN, Garber AJ, Luiz Gross J, Yuyan Duan R, Ravichandran S, Chen RS; Saxagliptin 014 Study Group. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care. 2009 Sep;32(9):1649-55. doi: 10.2337/dc08-1984. Epub 2009 May 28.'}, {'pmid': '31364269', 'type': 'DERIVED', 'citation': 'Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.'}, {'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': '23802840', 'type': 'DERIVED', 'citation': 'Rosenstock J, Gross JL, Aguilar-Salinas C, Hissa M, Berglind N, Ravichandran S, Fleming D. Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes. Diabet Med. 2013 Dec;30(12):1472-6. doi: 10.1111/dme.12267. Epub 2013 Jul 19.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin 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 pioglitizone 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 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.\n* HbA1c \\>= 7.0% and \\<= 10.0 %\n* Body mass index \\<= 40 kg/m2\n* Fasting C-peptide \\>= 1 ng/dL\n\nExclusion Criteria:\n\n* Symptomatic poorly controlled diabetes\n* Recent cardiac or cerebrovascular event\n* Serum creatinine \\>= 1.5 mg/dL for males and \\>= 1.4 mg/dL for females'}, 'identificationModule': {'nctId': 'NCT00121667', 'briefTitle': 'Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"', 'orgStudyIdInfo': {'id': 'CV181-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saxagliptin + Metformin (A)', 'description': 'Pioglitazone 15-45 mg (as needed for rescue)', 'interventionNames': ['Drug: Saxagliptin + Metformin', 'Drug: Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'Saxagliptin + Metformin (B)', 'description': 'Pioglitazone 15-45 mg (as needed for rescue)', 'interventionNames': ['Drug: Saxagliptin + Metformin', 'Drug: Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'Saxagliptin + Metformin (C)', 'description': 'Pioglitazone 15-45 mg (as needed for rescue)', 'interventionNames': ['Drug: Saxagliptin + Metformin', 'Drug: Pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+ Metformin (D)', 'description': 'Pioglitazone 15-45 mg (as needed for rescue)', 'interventionNames': ['Drug: Placebo + Metformin', 'Drug: Pioglitazone']}], 'interventions': [{'name': 'Saxagliptin + Metformin', 'type': 'DRUG', 'otherNames': ['BMS-477118'], 'description': 'Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)', 'armGroupLabels': ['Saxagliptin + Metformin (A)']}, {'name': 'Saxagliptin + Metformin', 'type': 'DRUG', 'otherNames': ['BMS-477118'], 'description': 'Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)', 'armGroupLabels': ['Saxagliptin + Metformin (B)']}, {'name': 'Saxagliptin + Metformin', 'type': 'DRUG', 'otherNames': ['BMS-477118'], 'description': 'Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)', 'armGroupLabels': ['Saxagliptin + Metformin (C)']}, {'name': 'Placebo + Metformin', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)', 'armGroupLabels': ['Placebo+ Metformin (D)']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'description': 'Tablets, Oral, 15 - 45 mg (as needed for rescue)', 'armGroupLabels': ['Placebo+ Metformin (D)', 'Saxagliptin + Metformin (A)', 'Saxagliptin + Metformin (B)', 'Saxagliptin + Metformin (C)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Calera', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.1029, 'lon': -86.7536}}, {'city': 'Haleyville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.22649, 'lon': -87.62141}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Sherwood', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.81509, 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