Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-01-04 @ 4:37 PM
Study NCT ID:
NCT01964950
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda Pharmaceutical Company Limited'}, '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 12 months', '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. Only adverse drug reactions were collected in the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Alogliptin + SU', 'description': 'Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.', 'otherNumAtRisk': 916, 'otherNumAffected': 19, 'seriousNumAtRisk': 916, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Alogliptin + Other', 'description': 'Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.', 'otherNumAtRisk': 160, 'otherNumAffected': 1, 'seriousNumAtRisk': 160, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 916, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin + SU', 'description': 'Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.'}, {'id': 'OG001', 'title': 'Alogliptin + Other', 'description': 'Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 12 months', 'description': "Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was defined as all participants who completed the study and had safety data available.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Serious Adverse Drug Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin + SU', 'description': 'Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.'}, {'id': 'OG001', 'title': 'Alogliptin + Other', 'description': 'Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 12 months', 'description': "Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was defined as all participants who completed the study and had safety data available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '830', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin', 'description': 'Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.'}], 'classes': [{'title': 'Baseline (n=830)', 'categories': [{'measurements': [{'value': '8.03', 'spread': '1.348', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1 (n = 655)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.708', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 (n = 710)', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '1.117', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 (n = 725)', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '1.117', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 (n = 670)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '1.106', 'groupId': 'OG000'}]}]}, {'title': 'Change at Final Assessment (n = 830)', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '1.145', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Objective Glycemic Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '830', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin', 'description': 'Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.'}], 'classes': [{'title': '<8.0 percent: Baseline', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}]}]}, {'title': '<8.0%: Final Assessment', 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000'}]}]}, {'title': '<7.0%: Baseline', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000'}]}]}, {'title': '<7.0%: Final Assessment', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000'}]}]}, {'title': '<6.0%: Baseline', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': '<6.0%: Final Assessment', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and final assessment (up to Month 12)', 'description': 'The rate of achieving objective glycemic control in HbA1c level was calculated at baseline and final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \\<8.0%, \\<7.0%, and \\<6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin', 'description': 'Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.'}], 'classes': [{'title': 'Baseline (n = 250)', 'categories': [{'measurements': [{'value': '151.1', 'spread': '43.07', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1 (n = 159)', 'categories': [{'measurements': [{'value': '-14.6', 'spread': '42.91', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 (n = 175)', 'categories': [{'measurements': [{'value': '-13.8', 'spread': '40.08', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 (n = 185)', 'categories': [{'measurements': [{'value': '-13.1', 'spread': '47.37', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 (n = 168)', 'categories': [{'measurements': [{'value': '-16.4', 'spread': '43.97', 'groupId': 'OG000'}]}]}, {'title': 'Change at Final Assessment (n = 250)', 'categories': [{'measurements': [{'value': '-13.7', 'spread': '49.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)', 'description': 'The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the SU treatment.', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin', 'description': 'Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.'}], 'classes': [{'title': 'Baseline (n = 33)', 'categories': [{'measurements': [{'value': '7.88', 'spread': '5.674', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1 (n = 15)', 'categories': [{'measurements': [{'value': '1.27', 'spread': '12.138', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 (n = 17)', 'categories': [{'measurements': [{'value': '0.21', 'spread': '3.474', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 (n = 20)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '5.629', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 (n = 22)', 'categories': [{'measurements': [{'value': '1.17', 'spread': '3.521', 'groupId': 'OG000'}]}]}, {'title': 'Change at Final Assessment (n = 33)', 'categories': [{'measurements': [{'value': '1.86', 'spread': '5.455', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 3, 6, 12, and final assessment (up to Month 12)', 'description': 'The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.', 'unitOfMeasure': 'micro units per milliliter (mcU/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Population (Alogliptin)', 'description': 'All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Data reports overall population,since data not collected separately per arm as specified in protocol', 'groupId': 'FG000', 'numSubjects': '1101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1076'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 221 investigative sites in Japan from 1-Jul-11 to 31-Dec-14.', 'preAssignmentDetails': 'Participants with type 2 diabetes mellitus started treatment with alogliptin as per routine clinical practice were observed. As per protocol, participants we enrolled in 1 observational group at the start and were divided into 2 groups based on Sulfonylurea (SU) use for analysis of safety endpoints. Participant data was collected for overall arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '1076', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alogliptin + SU', 'description': 'Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.'}, {'id': 'BG001', 'title': 'Alogliptin + Other', 'description': 'Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less Than (<) 65 Years', 'categories': [{'measurements': [{'value': '380', 'spread': '11.67', 'groupId': 'BG000'}, {'value': '69', 'spread': '12.19', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}]}, {'title': 'Greater Than or Equal to (>=) 65 Years', 'categories': [{'measurements': [{'value': '536', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '627', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '378', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '430', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '538', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '646', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '916', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '1076', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time From Diagnosis of Type 2 Diabetes', 'classes': [{'title': 'Less than (<)2 years', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': 'Greater than or equal to (>=)2 to <5 years', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': '>=5 to <10 years', 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}]}, {'title': '>=10 years', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': '<25 kilogram per square meter (kg/m^2)', 'categories': [{'measurements': [{'value': '326', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}]}, {'title': '>=25 kg/m^2', 'categories': [{'measurements': [{'value': '318', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Waist circumference', 'classes': [{'title': '<85 centimeter (cm) (Male)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': '>=85 cm (Male)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Unknown (Male)', 'categories': [{'measurements': [{'value': '384', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}]}, {'title': '<90 cm (Female)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': '>=90 cm (Female)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Unknown (Female)', 'categories': [{'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pregnancy Status', 'classes': [{'title': 'Not pregnant', 'categories': [{'measurements': [{'value': '378', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '430', 'groupId': 'BG002'}]}]}, {'title': 'Pregnant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This baseline characteristic was analyzed only in female participants.', 'unitOfMeasure': 'participants'}, {'title': 'Healthcare Category', 'classes': [{'title': 'Outpatient', 'categories': [{'measurements': [{'value': '891', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '1047', 'groupId': 'BG002'}]}]}, {'title': 'Inpatient', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Outpatient and Inpatient', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were categorized as outpatient, inpatient, and outpatient and inpatient (participants who were both outpatient and inpatient during some point at the time and 3 months prior to enrollment).', 'unitOfMeasure': 'participants'}, {'title': 'Degree of Renal Dysfunction', 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '412', 'groupId': 'BG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Estimated glomerular filtration rate (eGFR) was calculated using variables of gender, age at the start of treatment, and serum creatinine values, and severity was determined based on the following categories. If the serum creatinine value at the start of treatment was not listed, the severity was listed as "unknown." Normal: \\>=90 milliliter per minute (mL/min)/1.73\\^2, Mild: \\>=60 mL/min/1.73\\^2 to \\<90 mL/min/1.73\\^2 Moderate: \\>=30 mL/min/1.73\\^2 to \\<60 mL/min/1.73\\^2, Severe: \\<30 mL/min/1.73\\^2. eGFR = 194 \\* Cr\\^-1.094 \\* (age)\\^-0.287 (\\* 0.739 if female), where Cr is serum creatinine', 'unitOfMeasure': 'participants'}, {'title': 'History of Allergy', 'classes': [{'title': 'Did not have allergy', 'categories': [{'measurements': [{'value': '742', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '873', 'groupId': 'BG002'}]}]}, {'title': 'Had allergy', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Health-related Complications', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '837', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '982', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetic Complications', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '729', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '846', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Breakdown of Diabetic Complications', 'classes': [{'title': 'Diabetic nephropathy', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}, {'title': 'Diabetic retinopathy', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'Diabetic neuropathy', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This baseline characteristic was analyzed only in participants who had diabetic complications. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Hypertension', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '593', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '690', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Dyslipidemia', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '582', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '681', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Hyperuricemia', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '842', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '994', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Liver Damage', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '735', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '860', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Breakdown of Complications of Liver Damage', 'classes': [{'title': 'Hepatic steatosis', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'Hepatitis alcoholic', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Chronic hepatitis', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Hepatic cirrhosis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Liver damage complications were categorized as hepatic steatosis, hepatitis alcoholic, chronic hepatitis, hepatic cirrhosis and any other complications related to liver damage. This baseline characteristic was analyzed only in participants who had complications of liver damage. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'participants'}, {'title': 'Degree of Hepatic Dysfunction', 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '599', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '710', 'groupId': 'BG002'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Severity was determined using aspartate aminotransferase (AST) or alanine transaminase (ALT) values at the start of treatment with alogliptin. For the assessment of severity, the following categories were used and a higher severity grade for either AST or ALT serum levels was adopted. Normal: \\<50 international units per liter (IU/L), Grade 1: \\>=50 to \\<100 IU/L, Grade 2: \\>=100 to \\<500 IU/L, and Grade 3: \\>=500 IU/L.', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Renal Damage', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '790', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '923', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Breakdown of Complications of Renal Damage', 'classes': [{'title': 'Nephrotic syndrome', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Glomerulonephritis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Renal failure chronic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Renal damage complications were categorized as nephrotic syndrome, glomerulonephritis, renal failure chronic and any other complications related to renal damage. This baseline characteristic was analyzed only in participants who had renal damage complications. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Heart Disease', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '787', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '929', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Breakdown of Complications of Heart Disease', 'classes': [{'title': 'Cardiac failure', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Angina pectoris', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Heart disease complications were categorized as cardiac failure, myocardial infarction, angina pectoris, and any other complications related to heart disease. This baseline characteristic was analyzed only in participants who had heart disease complications. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Heart Failure', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '891', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '1048', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'New York Heart Association (NYHA) Heart Failure Classification', 'classes': [{'title': 'NYHA Class I', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'NYHA Class II', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'NYHA Class III', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'NYHA Class IV', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'NYHA functional classification ranges from Class I (participants with cardiac disease but without resulting limitations of physical activity), Class II (participants with cardiac disease resulting in slight limitation of physical activity), Class III (participants with cardiac disease resulting in marked limitation of physical activity), Class IV (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). This baseline measure was analyzed only for participants who had complications of heart failure.', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Stroke-related Disease', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '851', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '1004', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Breakdown of Complications of Stroke-related Disease', 'classes': [{'title': 'Cerebral infarction', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Cerebral haemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This baseline characteristic was analyzed only in participants who had complications of stroke-related disease.', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Allergic Disease', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '865', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '1018', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Complications of Malignant Tumor', 'classes': [{'title': 'Had complications', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Had no complications', 'categories': [{'measurements': [{'value': '897', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence of Medical History', 'classes': [{'title': 'Had medical history', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}, {'title': 'Did not have medical history', 'categories': [{'measurements': [{'value': '652', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '765', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Alcohol Consumption', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '527', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'In this measure, participants responded whether they consumed alcohol-containing beverages nearly every day or not.', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '372', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '423', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated Hemoglobin (HbA1c) Level', 'classes': [{'title': 'HbA1c <6.0 percent (%)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'HbA1c >=6.0% to <7.0%', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}, {'title': 'HbA1c >=7.0% to <8.0%', 'categories': [{'measurements': [{'value': '312', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}]}, {'title': 'HbA1c >=8.0%', 'categories': [{'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The safety analysis set was defined as all participants who completed the study and had safety data available.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2013-10-15', 'resultsFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2013-10-15', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-27', 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Adverse Drug Reactions', 'timeFrame': 'Baseline up to 12 months', 'description': "Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately."}, {'measure': 'Number of Participants Reporting One or More Serious Adverse Drug Reaction', 'timeFrame': 'Baseline up to 12 months', 'description': "Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.'}, {'measure': 'Percentage of Participants Achieving Objective Glycemic Control', 'timeFrame': 'Baseline and final assessment (up to Month 12)', 'description': 'The rate of achieving objective glycemic control in HbA1c level was calculated at baseline and final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \\<8.0%, \\<7.0%, and \\<6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose', 'timeFrame': 'Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)', 'description': 'The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the SU treatment.'}, {'measure': 'Change From Baseline in Fasting Insulin Level', 'timeFrame': 'Months 1, 3, 6, 12, and final assessment (up to Month 12)', 'description': 'The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug therapy'], 'conditions': ['Surveillance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.', 'detailedDescription': 'This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants with type 2 diabetes mellitus in a routine clinical setting.\n\nParticipants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000.\n\nThe usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with type 2 diabetes mellitus who have been examined at a medical institution', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who did not adequately respond to the following treatment • Treatment with sulfonylurea in addition to diet therapy and exercise therapy\n\nExclusion Criteria:\n\n1. Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate).\n2. Participants with severe infection, pre- or post-operative participants, or participants with serious traumatic injury (blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate).\n3. Participants with a history of hypersensitivity to any ingredient of Nesina.'}, 'identificationModule': {'nctId': 'NCT01964950', 'briefTitle': 'Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea', 'orgStudyIdInfo': {'id': '121-013'}, 'secondaryIdInfos': [{'id': 'JapicCTI-132266', 'type': 'REGISTRY', 'domain': 'JapicCTI'}, {'id': 'JapicCTI-R160882', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alogliptin', 'description': 'All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with Sulfonylurea (SU) or without SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Postmarketing Group Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}