Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-21 @ 12:13 AM
Study NCT ID:
NCT02324569
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C000595449', 'term': 'trelagliptin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 53', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.', 'otherNumAtRisk': 116, 'otherNumAffected': 59, 'seriousNumAtRisk': 116, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.', 'otherNumAtRisk': 119, 'otherNumAffected': 54, 'seriousNumAtRisk': 119, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Limb traumatic amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Radial nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal cord injury cervical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Medullary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Basilar artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I - End of the Screening Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.067', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-0.826', 'ciUpperLimit': '-0.443', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.097', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of the screening period (Week 0) and End of Treatment Period I (Up to Week 12)', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) That Occurred Before Start of Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': 'Reported data is the number of participants reporting one or more TEAEs that occurred before start of Treatment Period II in Treatment Group I and Treatment Group II.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.240', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.229', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.327', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.396', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.573', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.612', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.708', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.793', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.793', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.840', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.836', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.797', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.864', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.812', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.884', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.832', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.872', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.791', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.817', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.740', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.884', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.779', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.895', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.772', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.804', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.794', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.799', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.711', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.710', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.788', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.827', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.831', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)', 'description': 'Reported data was the change from baseline in HbA1c at each time point.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'spread': '29.73', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '28.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.6', 'spread': '32.19', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '36.49', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '32.13', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '39.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '39.65', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '42.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '41.31', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '37.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '39.65', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '38.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '36.08', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '39.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '38.76', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '37.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.9', 'spread': '39.46', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '35.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '35.58', 'groupId': 'OG000'}, {'value': '-14.9', 'spread': '33.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '40.45', 'groupId': 'OG000'}, {'value': '-14.7', 'spread': '36.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '36.88', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '38.43', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '38.00', 'groupId': 'OG000'}, {'value': '-19.8', 'spread': '35.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'spread': '43.40', 'groupId': 'OG000'}, {'value': '-21.0', 'spread': '33.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '45.44', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '34.49', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '39.40', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '42.44', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.1', 'spread': '42.48', 'groupId': 'OG000'}, {'value': '-18.3', 'spread': '35.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 53, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)', 'description': 'Reported data was the change from baseline in fasting plasma glucose at each time point.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'title': 'Pre-meal at the End of Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.5', 'spread': '34.13', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '45.17', 'groupId': 'OG001'}]}]}, {'title': '0.5 hr at the End of Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.6', 'spread': '36.82', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '51.12', 'groupId': 'OG001'}]}]}, {'title': '1 hr at the End of Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.6', 'spread': '43.08', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '51.02', 'groupId': 'OG001'}]}]}, {'title': '2 hr at the End of Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.9', 'spread': '42.23', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '59.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-meal and 0.5, 1, and 2 hr after-meal at Week 0 and 0.5, 1, and 2 hr after-meal at the End of Treatment Period I (Up to Week 12)', 'description': 'Reported data was the change from pre-meal in plasma glucose measured by the meal tolerance test at each time point.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Markedly Abnormal Values of Vital Signs Before Start of Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'title': 'Diastolic Blood Pressure <50 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pulse <50 Beats per minute(bpm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': 'Here "mmHg" is Millimeter of mercury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Markedly Abnormal Values of ECG Parameters Before Start of Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'title': 'QTcF Interval >450 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline in QTcF Interval >30 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': 'Here "QTcF" is Corrected QT interval by Fridericia formula, and "msec" is millisecond.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Markedly Abnormal Values of Laboratory Parameters (Total Bilirubin >2.0) Before Start of Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure..'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Total Hypoglycaemia After 1st Dose of Study Drug and Before Start of Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 53', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'OG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'classes': [{'title': 'Day 2 on Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'spread': '41.21', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '39.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 3 on Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '35.22', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '41.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 4 on Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '43.99', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '41.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 5 on Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '41.51', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '38.22', 'groupId': 'OG001'}]}]}, {'title': 'Day 6 on Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '33.79', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '43.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 7 on Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '38.15', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '37.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 on Treatment Period I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '39.63', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '37.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 on Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '41.98', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '51.90', 'groupId': 'OG001'}]}]}, {'title': 'Day 3 on Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.2', 'spread': '39.95', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '44.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 4 on Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'spread': '45.52', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '49.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 5 on Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '41.24', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '47.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 6 on Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '39.04', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '40.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 7 on Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.7', 'spread': '35.93', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '44.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 on Treatment Period II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.4', 'spread': '35.91', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '43.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 2, 3, 4, 5, 6, 7, and 8 in each Treatment Period (I and II) (Totally up to Week 17)', 'description': 'Reported data was the change from baseline in self-monitoring of blood glucose before breakfast.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'FG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Change Insulin Dosage Exceeding Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Inconvenient Schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 43 investigative sites in Japan, from 27 December 2014 to 28 December 2016.', 'preAssignmentDetails': 'Participants with a historical diagnosis of type 2 diabetes mellitus with inadequate glycemic control despite treatment with insulin therapy were enrolled in 1 of the 2 groups: Group I: 100 milligram (mg) SYR-472 in Period I followed by 100 mg SYR-472 in Period II, Group II: SYR-472 Placebo in Period I followed by 100 mg SYR-472 in Period II.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group I', 'description': 'SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'BG001', 'title': 'Treatment Group II', 'description': 'SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '10.89', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '11.11', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '10.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'All participants were enrolled in Japan.', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.39', 'spread': '3.593', 'groupId': 'BG000'}, {'value': '25.16', 'spread': '3.402', 'groupId': 'BG001'}, {'value': '25.27', 'spread': '3.490', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '125.9', 'spread': '92.75', 'groupId': 'BG000'}, {'value': '143.6', 'spread': '90.23', 'groupId': 'BG001'}, {'value': '135.0', 'spread': '91.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean duration between start of study and first time of diagnosis of type 2 diabetes mellitus was reported.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Type of Insulin Preparation', 'classes': [{'title': 'Pre-Mixed', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Intermediate-Acting', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Long-Acting', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Daily Dose of Insulin Preparation at Week -6', 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '9.32', 'groupId': 'BG000'}, {'value': '18.8', 'spread': '8.88', 'groupId': 'BG001'}, {'value': '19.3', 'spread': '9.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Unit', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine Clearance (Ccr)', 'classes': [{'categories': [{'measurements': [{'value': '109.3', 'spread': '36.09', 'groupId': 'BG000'}, {'value': '107.4', 'spread': '40.28', 'groupId': 'BG001'}, {'value': '108.3', 'spread': '38.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milliliter (mL)/minute (min)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Haemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.42', 'spread': '0.677', 'groupId': 'BG000'}, {'value': '8.50', 'spread': '0.675', 'groupId': 'BG001'}, {'value': '8.46', 'spread': '0.675', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose', 'classes': [{'categories': [{'measurements': [{'value': '160.6', 'spread': '32.86', 'groupId': 'BG000'}, {'value': '167.3', 'spread': '34.02', 'groupId': 'BG001'}, {'value': '164.1', 'spread': '33.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milligram (mg)/ Deciliter (dL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-hour (hr) Postprandial Plasma Glucose', 'classes': [{'categories': [{'measurements': [{'value': '290.0', 'spread': '52.08', 'groupId': 'BG000'}, {'value': '286.1', 'spread': '54.03', 'groupId': 'BG001'}, {'value': '288.0', 'spread': '52.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting C-Peptide', 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '0.527', 'groupId': 'BG000'}, {'value': '1.16', 'spread': '0.647', 'groupId': 'BG001'}, {'value': '1.12', 'spread': '0.593', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Nanogram (ng)/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycoalbumin', 'classes': [{'categories': [{'measurements': [{'value': '23.53', 'spread': '3.343', 'groupId': 'BG000'}, {'value': '23.70', 'spread': '3.290', 'groupId': 'BG001'}, {'value': '23.62', 'spread': '3.310', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '1,5-Anhydroglucitol', 'classes': [{'categories': [{'measurements': [{'value': '3.39', 'spread': '2.349', 'groupId': 'BG000'}, {'value': '3.28', 'spread': '2.978', 'groupId': 'BG001'}, {'value': '3.33', 'spread': '2.688', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Microgram (μg)/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulinogenic Index', 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.279', 'groupId': 'BG000'}, {'value': '0.38', 'spread': '0.687', 'groupId': 'BG001'}, {'value': '0.34', 'spread': '0.525', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Insulinogenic Index=Increment of insulin at 30 minutes post-meal / Increment of blood glucose at 30 minutes post-meal', 'unitOfMeasure': 'microunits*dL/mg*mL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Randomized set: Randomized set included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2014-12-19', 'resultsFirstSubmitDate': '2017-12-27', 'studyFirstSubmitQcDate': '2014-12-23', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-19', 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I - End of the Screening Period)', 'timeFrame': 'End of the screening period (Week 0) and End of Treatment Period I (Up to Week 12)'}, {'measure': 'Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) That Occurred Before Start of Treatment Period II', 'timeFrame': 'Up to Week 12', 'description': 'Reported data is the number of participants reporting one or more TEAEs that occurred before start of Treatment Period II in Treatment Group I and Treatment Group II.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c', 'timeFrame': 'Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)', 'description': 'Reported data was the change from baseline in HbA1c at each time point.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose', 'timeFrame': 'Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 53, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)', 'description': 'Reported data was the change from baseline in fasting plasma glucose at each time point.'}, {'measure': 'Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I', 'timeFrame': 'Pre-meal and 0.5, 1, and 2 hr after-meal at Week 0 and 0.5, 1, and 2 hr after-meal at the End of Treatment Period I (Up to Week 12)', 'description': 'Reported data was the change from pre-meal in plasma glucose measured by the meal tolerance test at each time point.'}, {'measure': 'Number of Participants With Markedly Abnormal Values of Vital Signs Before Start of Treatment Period II', 'timeFrame': 'Up to Week 12', 'description': 'Here "mmHg" is Millimeter of mercury.'}, {'measure': 'Number of Participants With Markedly Abnormal Values of ECG Parameters Before Start of Treatment Period II', 'timeFrame': 'Up to Week 12', 'description': 'Here "QTcF" is Corrected QT interval by Fridericia formula, and "msec" is millisecond.'}, {'measure': 'Number of Participants With Markedly Abnormal Values of Laboratory Parameters (Total Bilirubin >2.0) Before Start of Treatment Period II', 'timeFrame': 'Up to Week 12'}, {'measure': 'Number of Participants With Total Hypoglycaemia After 1st Dose of Study Drug and Before Start of Treatment Period II', 'timeFrame': 'Up to Week 53'}, {'measure': 'Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast', 'timeFrame': 'Baseline and Day 2, 3, 4, 5, 6, 7, and 8 in each Treatment Period (I and II) (Totally up to Week 17)', 'description': 'Reported data was the change from baseline in self-monitoring of blood glucose before breakfast.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacological therapy'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purposes of this study is to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy compared with placebo in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.', 'detailedDescription': 'This is a phase 4, multicenter, randomized, double-blind, parallel-group, comparative study using placebo (Treatment Period I) and a phase 4, multicenter, open-label, long-term study (Treatment Period II) to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipant eligibility is determined according to the following criteria:\n\n1. The participant has a diagnosis of type 2 diabetes mellitus.\n2. The participant has a fasting C-peptide level of 0.6 ng/mL or higher at the start of the screening period (Week -6) and Week -2 of the screening period.\n3. The participant has a Haemoglobin A1c (HbA1c) value of 7.5% or higher but less than 10.0% at Week -2 of the screening period.\n4. The participant has an HbA1c value difference between the start of the screening period (Week -6) and Week -2 of the screening period within 10.0%\\* (\\* rounded to one decimal place) of the HbA1c value at the start of the screening period (Week -6).\n5. The participant has been on a fixed diet and/or exercise therapy (if any) from at least 6 weeks prior to the start of the screening period (Week -6).\n6. The participant is being treated with insulin preparations alone (≥8 units/day and ≤40 units/day) \\*\\* from at least 6 weeks prior to the start of the screening period (Week -6) at a fixed dose and regimen of the insulin preparation.\n\n * The participant on any one of the following insulin monotherapies: mixed (rapid-acting or short-acting insulin containing no more than 30% volume), intermediate-acting, or long-acting soluble insulin preparations\n7. The participant is deemed appropriate for treatment with a combination of insulin and another antidiabetic drug at the start of the screening period (Week -6) by the investigator or subinvestigator.\n8. The participants with controlled and stable blood pressure will not need any change in the dose of antihypertensive drugs (including discontinuation and suspension) or additional antihypertensive drugs during the study period as assessed by the investigator or subinvestigator.\n9. The participant is male or female and aged 20 years or older at the time of informed consent.\n10. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent until one month after the end of the study.\n11. In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.\n12. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.\n\nExclusion Criteria:\n\nAny participant who meets any of the following criteria will not qualify for entry into the study:\n\n1. The participants has clinical manifestations of hepatic impairment \\[e.g., Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥2.5 times the upper limit of normal or total bilirubin of ≥2.0 mg/dL at the start of the screening period (Week -6) or at Week -2 of the screening period\\].\n2. The participant has moderate or severe renal impairment or end-stage renal failure \\[e.g., creatinine clearance (Ccr) \\<50 mL/min at the start of the screening period (Week -6) or Week -2 of the screening period\\].\n3. The participant has any serious cardiac diseases, cerebrovascular disorders, or serious pancreatic or hematological diseases (e.g., participants who require inpatient treatment or are hospitalized for treatment within 24 weeks prior to the start of the screening period).\n4. The participant has, in the judgment of the investigator or subinvestigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at the start of the screening period (Week - 6) or Week -2 of the screening period.\n5. The participant has a systolic blood pressure of 180 mmHg or higher or a diastolic blood pressure of 110 mmHg or higher during the screening period.\n6. The participant is on at least two antidiabetic therapies other than one insulin preparation one day before 6 weeks prior to the start of the screening period (Week -6) (43 days prior to the start of the screening period).\n7. The participants altered the dose and regimen of their insulin preparation within 6 weeks prior to the start of the screening period or during the screening period.\n8. The participant experienced hypoglycemia (participants with a blood glucose level of ≤70 mg/dL or hypoglycemic symptoms) within 6 weeks prior to the start of the screening period or during the screening period (at least twice per week).\n9. The participant has a fasting blood glucose level of 240 mg/dL or higher at the start of the screening period (Week -6) or at Week -2 of the screening period.\n10. The participant has malignancies.\n11. The participant has a history of hypersensitivity or allergies to dipeptidyl peptidase 4 (DPP-4) inhibitors or insulin preparations.\n12. The participant has a history of gastrectomy or small intestinal resection.\n13. The participant is habitual drinker consuming a daily average of more than 100 mL of alcohol.\n14. The participant has a history of drug abuse (defined as the use of an illegal drug) or alcohol dependence.\n15. The participant is required to take excluded medications during the study period.\n16. The participant has received SYR-472 in a previous clinical study.\n17. The participant is deemed to be in a condition contraindicating treatment as specified in the package insert of insulin preparations by the investigator or subinvestigator.\n18. The participant received any investigational products (including study drugs in a post-marketing clinical study) within 12 weeks prior to the start of the screening period.\n19. The participant is participating in other clinical studies at the time of informed consent.\n20. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.\n21. The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.\n22. The participant is hospitalized during the screening period or deemed as requiring hospitalization during the study period by the investigator or subinvestigator, unless the hospitalization is for short-term evaluations including complete health checkups.\n23. The participant is deemed to be ineligible for the study for any other reason by the investigator or subinvestigator.'}, 'identificationModule': {'nctId': 'NCT02324569', 'briefTitle': 'A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative Study and a Phase 4, Multicenter, Open-label, Long-term Study to Evaluate the Safety and Efficacy of SYR-472 When Orally Administered at a Dose of 100 mg Once Weekly as an add-on to Insulin Therapy in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Treatment With Insulin Preparations in Addition to Diet and/or Exercise Therapy', 'orgStudyIdInfo': {'id': 'SYR-472/CCT-101'}, 'secondaryIdInfos': [{'id': 'U1111-1164-8291', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group I', 'description': 'One tablet of SYR-472 100 mg orally once weekly before breakfast', 'interventionNames': ['Drug: SYR-472']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group II', 'description': 'One tablet of SYR-472 100 mg orally or one placebo tablet orally once weekly before breakfast', 'interventionNames': ['Drug: SYR-472', 'Drug: Placebo']}], 'interventions': [{'name': 'SYR-472', 'type': 'DRUG', 'description': 'SYR-472 tablets', 'armGroupLabels': ['Treatment Group I', 'Treatment Group II']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets', 'armGroupLabels': ['Treatment Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Koga', 'state': 'Ibaragi', 'country': 'Japan', 'geoPoint': {'lat': 36.18333, 'lon': 139.71667}}, {'city': 'Mito', 'state': 'Ibaragi', 'country': 'Japan', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'city': 'Naka', 'state': 'Ibaragi', 'country': 'Japan', 'geoPoint': {'lat': 36.05, 'lon': 140.16667}}, {'city': 'Tsuchiura', 'state': 'Ibaragi', 'country': 'Japan', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'city': 'Ushiku', 'state': 'Ibaragi', 'country': 'Japan', 'geoPoint': {'lat': 35.96667, 'lon': 140.13333}}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Satsumakawauchi', 'state': 'Kagoshima-ken', 'country': 'Japan'}, {'city': 'Chigasaki', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.33638, 'lon': 139.40434}}, {'city': 'Fujisawa', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Hirakata', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Kashihara', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 135.61667}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Ageo', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.97145, 'lon': 139.61382}}, {'city': 'Sangou', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Shimada', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 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{'lat': 35.33638, 'lon': 139.40434}}, {'city': 'Chiyoda-ku', 'country': 'Japan'}, {'city': 'Fujisawa', 'country': 'Japan', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hamamatsu', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Hirakata', 'country': 'Japan', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Hirosaki', 'country': 'Japan', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanazawa', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Kashiwara', 'country': 'Japan', 'geoPoint': {'lat': 34.45, 'lon': 135.76667}}, {'city': 'Koga', 'country': 'Japan', 'geoPoint': {'lat': 36.18333, 'lon': 139.71667}}, {'city': 'Koyama', 'country': 'Japan', 'geoPoint': {'lat': 36.64457, 'lon': 138.31817}}, {'city': 'Kumamoto', 'country': 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