Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT01318135
Status:
COMPLETED
Last Update Posted:
2012-08-16
First Post:
2011-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'C520853', 'term': 'alogliptin'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '+81-6-6204-5257', 'title': 'General Manager', 'organization': 'Japan Development Center, Pharmaceutical Development Division'}, 'certainAgreement': {'otherDetails': 'The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.', 'description': 'The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.', 'eventGroups': [{'id': 'EG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.', 'otherNumAtRisk': 150, 'otherNumAffected': 116, 'seriousNumAtRisk': 150, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.', 'otherNumAtRisk': 152, 'otherNumAffected': 134, 'seriousNumAtRisk': 152, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.', 'otherNumAtRisk': 142, 'otherNumAffected': 108, 'seriousNumAtRisk': 142, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.', 'otherNumAtRisk': 145, 'otherNumAffected': 113, 'seriousNumAtRisk': 145, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cerebral circulatory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gas gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Malignant neoplasm of renal pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'title': 'Serious Adverse Event', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Other Adverse Event (≥3% Frequency Threshold)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 Weeks.', 'description': 'Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. 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6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.506', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.515', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.486', 'groupId': 'OG002'}, {'value': '-0.59', 'spread': '0.394', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.626', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.589', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.576', 'groupId': 'OG002'}, {'value': '-0.71', 'spread': '0.489', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 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6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.754', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.689', 'groupId': 'OG001'}, {'value': '-0.67', 'spread': '0.648', 'groupId': 'OG002'}, {'value': '-0.78', 'spread': '0.553', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 24).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 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6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.841', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.721', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '0.659', 'groupId': 'OG002'}, {'value': '-0.84', 'spread': '0.596', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 28.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 32).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.868', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.736', 'groupId': 'OG001'}, {'value': '-0.67', 'spread': '0.644', 'groupId': 'OG002'}, {'value': '-0.81', 'spread': '0.634', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 32.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 36).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.881', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.745', 'groupId': 'OG001'}, {'value': '-0.67', 'spread': '0.659', 'groupId': 'OG002'}, {'value': '-0.79', 'spread': '0.653', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 36.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 40).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 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Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'spread': '46.24', 'groupId': 'OG000'}, {'value': '83.2', 'spread': '43.61', 'groupId': 'OG001'}, {'value': '62.5', 'spread': '42.91', 'groupId': 'OG002'}, {'value': '62.7', 'spread': '32.81', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52.', 'description': 'The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '143', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.8', 'spread': '45.47', 'groupId': 'OG000'}, {'value': '84.9', 'spread': '44.35', 'groupId': 'OG001'}, {'value': '63.5', 'spread': '43.06', 'groupId': 'OG002'}, {'value': '63.7', 'spread': '32.32', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Final Visit (up to Week 52).', 'description': 'The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values are from the Full Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.\n\n\\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.'}, {'id': 'FG001', 'title': 'CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.\n\n\\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.'}, {'id': 'FG002', 'title': 'Glimepiride Monotherapy Group* → 12.5 mg Combination Group', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.\n\n\\*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.'}, {'id': 'FG003', 'title': 'Glimepiride Monotherapy Group* → 25 mg Combination Group', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.\n\n\\*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.'}, {'id': 'FG004', 'title': 'CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.\n\n\\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.'}, {'id': 'FG005', 'title': 'CCT/006 - 25 mg Dose Group* → 25 mg Combination Group', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.\n\n\\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.'}, {'id': 'FG006', 'title': 'Metformin Monotherapy Group* → 12.5 mg Combination Group', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.\n\n\\*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.'}, {'id': 'FG007', 'title': 'Metformin Monotherapy Group* → 25 mg Combination Group', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.\n\n\\*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.'}], 'periods': [{'title': 'Enrolled - Long-Term Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '91'}, {'groupId': 'FG005', 'numSubjects': '90'}, {'groupId': 'FG006', 'numSubjects': '50'}, {'groupId': 'FG007', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '91'}, {'groupId': 'FG005', 'numSubjects': '90'}, {'groupId': 'FG006', 'numSubjects': '50'}, {'groupId': 'FG007', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Treatment Complications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Entered - Long-Term Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients participated in CCT-005 but not entered OCT-005 are excluded in Participant Flow.', 'groupId': 'FG000', 'numSubjects': '97'}, {'comment': 'Patients participated in CCT-005 but not entered OCT-005 are excluded in Participant Flow.', 'groupId': 'FG001', 'numSubjects': '102'}, {'comment': 'Patients participated in CCT-005 but not entered OCT-005 are excluded in Participant Flow.', 'groupId': 'FG002', 'numSubjects': '46'}, {'comment': 'Patients participated in CCT-005 but not entered OCT-005 are excluded in Participant Flow.', 'groupId': 'FG003', 'numSubjects': '49'}, {'comment': 'Patients participated in CCT-006 but not entered OCT-005 are excluded in Participant Flow.', 'groupId': 'FG004', 'numSubjects': '90'}, {'comment': 'Patients participated in CCT-006 but not entered OCT-005 are excluded in Participant Flow.', 'groupId': 'FG005', 'numSubjects': '87'}, {'comment': 'Patients participated in CCT-006 but not entered OCT-005 are excluded in Participant Flow.', 'groupId': 'FG006', 'numSubjects': '50'}, {'comment': 'Patients participated in CCT-006 but not entered OCT-005 are excluded in Participant Flow.', 'groupId': 'FG007', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '296 participants enrolled and 294 completed glimepiride add-on study and entered the present study.', 'groupId': 'FG000', 'numSubjects': '80'}, {'comment': '296 participants enrolled and 294 completed glimepiride add-on study and entered the present study.', 'groupId': 'FG001', 'numSubjects': '89'}, {'comment': '296 participants enrolled and 294 completed glimepiride add-on study and entered the present study.', 'groupId': 'FG002', 'numSubjects': '38'}, {'comment': '296 participants enrolled and 294 completed glimepiride add-on study and entered the present study.', 'groupId': 'FG003', 'numSubjects': '42'}, {'comment': '280 participants enrolled and 276 completed metformin add-on study and entered the present study.', 'groupId': 'FG004', 'numSubjects': '81'}, {'comment': '280 participants enrolled and 276 completed metformin add-on study and entered the present study.', 'groupId': 'FG005', 'numSubjects': '83'}, {'comment': '280 participants enrolled and 276 completed metformin add-on study and entered the present study.', 'groupId': 'FG006', 'numSubjects': '49'}, {'comment': '280 participants enrolled and 276 completed metformin add-on study and entered the present study.', 'groupId': 'FG007', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Use of Excluded Medications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants enrolled at 58 investigative sites in Japan from 06 January 2009 to 23 January 2010.', 'preAssignmentDetails': 'Participants who had completed a core phase 2/3 glimepiride (SYR-322/CCT-005; NCT01318083) or metformin (SYR-322/CCT-006; NCT01318109) add-on study were enrolled in one of four, once daily (QD) or twice-daily (BID) treatment groups. Five participants completed OCT-005 study without receiving the study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}, {'value': '589', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'BG001', 'title': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.'}, {'id': 'BG002', 'title': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'BG003', 'title': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≤ 64 years', 'categories': [{'measurements': [{'value': '93', 'spread': '9.50', 'groupId': 'BG000'}, {'value': '105', 'spread': '8.92', 'groupId': 'BG001'}, {'value': '142', 'spread': '8.12', 'groupId': 'BG002'}, {'value': '145', 'spread': '8.41', 'groupId': 'BG003'}, {'value': '485', 'groupId': 'BG004'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants randomized in core phase 2/3 glimepiride add-on study, excluding those randomized to the "glimepiride monotherapy group" was 304. Participants randomized in core phase 2/3 metformin add-on study, excluding those randomized to the "metformin monotherapy group" was 287. The following are included in baseline: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '195', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 576}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-07', 'studyFirstSubmitDate': '2011-03-16', 'resultsFirstSubmitDate': '2011-06-08', 'studyFirstSubmitQcDate': '2011-03-16', 'lastUpdatePostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-07', 'studyFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events.', 'timeFrame': '52 Weeks.', 'description': 'Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 24).', 'timeFrame': 'Baseline and Week 24.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 28).', 'timeFrame': 'Baseline and Week 28.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 32).', 'timeFrame': 'Baseline and Week 32.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 36).', 'timeFrame': 'Baseline and Week 36.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 40).', 'timeFrame': 'Baseline and Week 40.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 44).', 'timeFrame': 'Baseline and Week 44.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 48).', 'timeFrame': 'Baseline and Week 48.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 52).', 'timeFrame': 'Baseline and Week 52.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Final Visit).', 'timeFrame': 'Baseline and Final Visit (up to 52).', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit and glycosylated hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting blood glucose collected at week 8 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting blood glucose collected at week 12 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting blood glucose collected at week 6 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting blood glucose collected at week 20 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 24).', 'timeFrame': 'Baseline and Week 24.', 'description': 'The change between the value of fasting blood glucose collected at week 24 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 28).', 'timeFrame': 'Baseline and Week 28.', 'description': 'The change between the value of fasting blood glucose collected at week 28 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 32).', 'timeFrame': 'Baseline and Week 32.', 'description': 'The change between the value of fasting blood glucose collected at week 32 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 36).', 'timeFrame': 'Baseline and Week 36.', 'description': 'The change between the value of fasting blood glucose collected at week 36 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 40).', 'timeFrame': 'Baseline and Week 40.', 'description': 'The change between the value of fasting blood glucose collected at week 40 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 44).', 'timeFrame': 'Baseline and Week 44.', 'description': 'The change between the value of fasting blood glucose collected at week 44 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 48).', 'timeFrame': 'Baseline and Week 48.', 'description': 'The change between the value of fasting blood glucose collected at week 48 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Week 52).', 'timeFrame': 'Baseline and Week 52.', 'description': 'The change between the value of fasting blood glucose collected at week 52 and baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (Final Visit).', 'timeFrame': 'Baseline and Final Visit (up to Week 52).', 'description': 'The change between the value of fasting blood glucose collected at final visit and baseline.'}, {'measure': 'Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.'}, {'measure': 'Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).', 'timeFrame': 'Baseline and Week 24.', 'description': 'The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.'}, {'measure': 'Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).', 'timeFrame': 'Baseline and Week 52.', 'description': 'The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.'}, {'measure': 'Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).', 'timeFrame': 'Baseline and Final Visit (up to Week 52).', 'description': 'The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus - Type 2', 'Diabetes Mellitus', 'Drug Therapy'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24843617', 'type': 'DERIVED', 'citation': 'Seino Y, Hiroi S, Hirayama M, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Investig. 2012 Dec 20;3(6):517-25. doi: 10.1111/j.2040-1124.2012.00226.x. Epub 2012 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).', 'detailedDescription': 'Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.\n\nTakeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.\n\nThis was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3 metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCommon criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:\n\n1. Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.\n2. Was capable of understanding and complying with protocol requirements.\n3. Signed a written informed consent form prior to the initiation of any study procedure.\n\nExclusion Criteria:\n\nCommon criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:\n\n1. With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).\n2. With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).\n3. With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).\n\nCriteria that applied only to participants completing the core phase 2/3 metformin add-on study:\n\n1\\. With history or symptoms of lactic acidosis.'}, 'identificationModule': {'nctId': 'NCT01318135', 'briefTitle': 'Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or Metformin in Subjects With Type 2 Diabetes in Japan', 'orgStudyIdInfo': {'id': 'SYR-322/OCT-005'}, 'secondaryIdInfos': [{'id': 'JapicCTI-090902', 'type': 'REGISTRY', 'domain': 'JapicCTI'}, {'id': 'U1111-1119-6196', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID', 'interventionNames': ['Drug: Alogliptin and glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID', 'interventionNames': ['Drug: Alogliptin and glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID', 'interventionNames': ['Drug: Alogliptin and metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID', 'interventionNames': ['Drug: Alogliptin and metformin']}], 'interventions': [{'name': 'Alogliptin and glimepiride', 'type': 'DRUG', 'otherNames': ['SYR-322', 'Amaryl'], 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.', 'armGroupLabels': ['Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID']}, {'name': 'Alogliptin and glimepiride', 'type': 'DRUG', 'otherNames': ['SYR-322', 'Amaryl'], 'description': 'Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.', 'armGroupLabels': ['Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID']}, {'name': 'Alogliptin and metformin', 'type': 'DRUG', 'otherNames': ['SYR-322', 'Glycoran'], 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.', 'armGroupLabels': ['Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID']}, {'name': 'Alogliptin and metformin', 'type': 'DRUG', 'otherNames': ['SYR-322', 'Glycoran'], 'description': 'Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.', 'armGroupLabels': ['Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Professor, Diabetes and Endocrine Division', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Medicine, Kawasaki Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}