Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT02098733
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2014-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'C057619', 'term': 'glimepiride'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, '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': 'For 12 months', 'description': 'At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.', 'otherNumAtRisk': 1158, 'otherNumAffected': 0, 'seriousNumAtRisk': 1158, 'seriousNumAffected': 23}], 'seriousEvents': [{'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Marasmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'classes': [{'title': 'Hypoglycaemia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Dysgeusia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypoaesthesia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac failure', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac failure congestive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pleural effusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Eructation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cholelithiasis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Drug eruption', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Swelling face', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urticaria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Face oedema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Feeling abnormal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hunger', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Oedema', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Oedema peripheral', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Sudden death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Blood creatine phosphokinase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Blood triglycerides increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Blood glucose decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Weight increased', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For 12 months', 'description': 'Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'classes': [{'title': 'Month 3 (n=1016)', 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.936', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=893)', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.144', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=831)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '1.107', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=462)', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '1.196', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (n=1,054)', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '1.152', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with data available.'}, {'type': 'SECONDARY', 'title': 'Glycosylated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'classes': [{'title': 'At the start of treatment (n=1054)', 'categories': [{'measurements': [{'value': '7.70', 'spread': '1.302', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=1016)', 'categories': [{'measurements': [{'value': '7.25', 'spread': '1.102', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=893)', 'categories': [{'measurements': [{'value': '7.14', 'spread': '1.059', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=831)', 'categories': [{'measurements': [{'value': '7.08', 'spread': '0.995', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=462)', 'categories': [{'measurements': [{'value': '7.12', 'spread': '1.077', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (n=1054)', 'categories': [{'measurements': [{'value': '7.13', 'spread': '1.100', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline.', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with data available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Blood Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'classes': [{'title': 'Month 3 (n=331)', 'categories': [{'measurements': [{'value': '-16.7', 'spread': '44.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=287)', 'categories': [{'measurements': [{'value': '-14.3', 'spread': '48.17', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=273)', 'categories': [{'measurements': [{'value': '-15.7', 'spread': '45.94', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=462)', 'categories': [{'measurements': [{'value': '-12.5', 'spread': '45.50', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (n=369)', 'categories': [{'measurements': [{'value': '-16.4', 'spread': '47.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with data available.'}, {'type': 'SECONDARY', 'title': 'Fasting Blood Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'classes': [{'title': 'At the start of treatment (n=369)', 'categories': [{'measurements': [{'value': '147.2', 'spread': '51.87', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=331)', 'categories': [{'measurements': [{'value': '130.2', 'spread': '43.18', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=287)', 'categories': [{'measurements': [{'value': '131.7', 'spread': '41.09', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=273)', 'categories': [{'measurements': [{'value': '129.2', 'spread': '36.71', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=462)', 'categories': [{'measurements': [{'value': '126.8', 'spread': '42.01', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (n=369)', 'categories': [{'measurements': [{'value': '130.9', 'spread': '46.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated fasting blood glucose level from baseline at each test time point.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with data available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'classes': [{'title': 'Month 3 (n=39)', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '1.376', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=32)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '1.163', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=30)', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '2.121', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=18)', 'categories': [{'measurements': [{'value': '0.58', 'spread': '2.582', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (n=46)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '2.397', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'μU/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with data available.'}, {'type': 'SECONDARY', 'title': 'Fasting Insulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'classes': [{'title': 'At the start of treatment (n=46)', 'categories': [{'measurements': [{'value': '5.78', 'spread': '2.880', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=39)', 'categories': [{'measurements': [{'value': '5.38', 'spread': '2.885', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=32)', 'categories': [{'measurements': [{'value': '5.48', 'spread': '2.964', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=30)', 'categories': [{'measurements': [{'value': '5.40', 'spread': '2.642', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=18)', 'categories': [{'measurements': [{'value': '6.57', 'spread': '3.789', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (n=46)', 'categories': [{'measurements': [{'value': '5.77', 'spread': '3.238', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated fasting insulin level at each test time point.', 'unitOfMeasure': 'μU/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Data Not Available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 182 investigative sites in Japan from 15 June 2011 to 31 May 2014.', 'preAssignmentDetails': 'Participants with a historical diagnosis of type 2 diabetes mellitus for whom therapy with pioglitazone combined with glimepiride is suitable and long-term treatment is considered necessary were enrolled in one treatment group to receive pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1158', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone/Glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '12.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '539', 'groupId': 'BG000'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '619', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '539', 'groupId': 'BG000'}]}]}, {'title': '≥65 to <74 years', 'categories': [{'measurements': [{'value': '354', 'groupId': 'BG000'}]}]}, {'title': '≥75 years', 'categories': [{'measurements': [{'value': '265', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '439', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '719', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pregnancy Status <Females>', 'classes': [{'title': 'Not pregnant', 'categories': [{'measurements': [{'value': '439', 'groupId': 'BG000'}]}]}, {'title': 'Pregnant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Female participants only (n=439)', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '67.86', 'spread': '14.281', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight Categorical', 'classes': [{'title': '<40 kg', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '≥40 to <50 kg', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}, {'title': '≥50 to <60 kg', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}]}]}, {'title': '≥60 to <70 kg', 'categories': [{'measurements': [{'value': '327', 'groupId': 'BG000'}]}]}, {'title': '≥70 kg', 'categories': [{'measurements': [{'value': '427', 'groupId': 'BG000'}]}]}, {'title': 'Unmeasured', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.19', 'spread': '4.401', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'BMI data was available for 1011 participants.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI Categorical', 'classes': [{'title': '<18.5 kg/m^2', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '≥18.5 to <25 kg/m^2', 'categories': [{'measurements': [{'value': '422', 'groupId': 'BG000'}]}]}, {'title': '≥25 to <30 kg/m^2', 'categories': [{'measurements': [{'value': '412', 'groupId': 'BG000'}]}]}, {'title': '≥30 kg/m^2', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Type 2 Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '9.12', 'spread': '8.188', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Duration of type 2 diabetes data was available for 788 participants.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Type 2 Diabetes, Categorical', 'classes': [{'title': '<2 years', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}, {'title': '≥2 to <5 years', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}]}]}, {'title': '≥5 to <10 years', 'categories': [{'measurements': [{'value': '262', 'groupId': 'BG000'}]}]}, {'title': '≥10 years', 'categories': [{'measurements': [{'value': '274', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '370', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Healthcare Category', 'classes': [{'title': 'Outpatient', 'categories': [{'measurements': [{'value': '1155', 'groupId': 'BG000'}]}]}, {'title': 'Inpatient', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Allergies', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '959', 'groupId': 'BG000'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence of Complications', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '1050', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Breakdown of Complications', 'classes': [{'title': 'Microangiopathy', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}]}]}, {'title': 'Diabetic nephropathy', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}, {'title': 'Diabetic retinopathy', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'Diabetic neuropathy', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '723', 'groupId': 'BG000'}]}]}, {'title': 'Dyslipidaemia', 'categories': [{'measurements': [{'value': '787', 'groupId': 'BG000'}]}]}, {'title': 'Hyperuricaemia', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}, {'title': 'Liver disease', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}]}]}, {'title': 'Renal disease', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}]}]}, {'title': 'Heart disease', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}]}]}, {'title': 'Cerebrovascular disease', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'Malignant tumor', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants may be accounted for in more than 1 category.', 'unitOfMeasure': 'participants'}, {'title': 'Presence of Medical History', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '897', 'groupId': 'BG000'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol History (Drinking Alcohol-Containing Beverages Most Days)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '596', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '375', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '516', 'groupId': 'BG000'}]}]}, {'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Compliance Rate with the Diet Regimen (At the Start of Treatment)', 'classes': [{'title': '≥ 90%', 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}]}]}, {'title': '≥ 70%', 'categories': [{'measurements': [{'value': '371', 'groupId': 'BG000'}]}]}, {'title': '≥ 50%', 'categories': [{'measurements': [{'value': '286', 'groupId': 'BG000'}]}]}, {'title': '< 50%', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}, {'title': 'Undone or compliance status is unknown', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Compliance rate with the Exercise Regimen (At the Start of Treatment)', 'classes': [{'title': '≥ 90%', 'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}, {'title': '≥ 70%', 'categories': [{'measurements': [{'value': '279', 'groupId': 'BG000'}]}]}, {'title': '≥ 50%', 'categories': [{'measurements': [{'value': '348', 'groupId': 'BG000'}]}]}, {'title': '< 50%', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}]}]}, {'title': 'Undone or compliance status is unknown', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Timing of Initiation of Pioglitazone Before the Start of Study Treatment', 'classes': [{'title': '≥ 3 months', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}, {'title': '< 3 months', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Data is only available for participants who were administered pioglitazone alone prior to beginning study treatment (n=189).', 'unitOfMeasure': 'participants'}, {'title': 'Timing of Initiation of Glimepiride Before the Start of Study Treatment', 'classes': [{'title': '≥ 3 months', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}]}]}, {'title': '< 3 months', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Data is only available for participants who were administered glimepiride alone prior to beginning study treatment (n=338).', 'unitOfMeasure': 'participants'}, {'title': 'Timing of Initiation of Pioglitazone and Glimepiride Before the Start of Study Treatment', 'classes': [{'title': '≥ 3 months', 'categories': [{'measurements': [{'value': '347', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Data is only available for participants who were administered both pioglitazone and glimepiride prior to beginning study treatment (n=558).', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated Haemoglobin (HbA1c) at the Start of Study Treatment', 'classes': [{'title': '< 6.0%', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': '≥ 6.0% to < 7.0%', 'categories': [{'measurements': [{'value': '274', 'groupId': 'BG000'}]}]}, {'title': '≥ 7.0% to < 8.0%', 'categories': [{'measurements': [{'value': '427', 'groupId': 'BG000'}]}]}, {'title': '≥ 8.0%', 'categories': [{'measurements': [{'value': '355', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c at the Start of Study Treatment', 'classes': [{'categories': [{'measurements': [{'value': '7.71', 'spread': '1.313', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c data was available for 1091 participants.', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All enrolled participants with available data.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2014-03-25', 'resultsFirstSubmitDate': '2015-12-16', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-16', 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Drug Reactions', 'timeFrame': 'For 12 months', 'description': 'Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline, and Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.'}, {'measure': 'Glycosylated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline, and Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose Level', 'timeFrame': 'Baseline, Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.'}, {'measure': 'Fasting Blood Glucose Level', 'timeFrame': 'Baseline, Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated fasting blood glucose level from baseline at each test time point.'}, {'measure': 'Change From Baseline in Fasting Insulin Level', 'timeFrame': 'Baseline, Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.'}, {'measure': 'Fasting Insulin Level', 'timeFrame': 'Baseline, Months 3, 6, 9, 12 and at Final Assessment', 'description': 'Tabulated fasting insulin level at each test time point.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacological therapy'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical setting.', 'detailedDescription': 'This a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus in the routine clinical setting.\n\nThe usual adult dosage is one tablet of Sonias administered orally once daily before or after breakfast (15 mg/1 mg or 30 mg/3 mg of pioglitazone/glimepiride).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus for whom a physician has concluded that combination therapy with pioglitazone hydrochloride and glimepiride is appropriate and for whom long-term treatment with Sonias Combination Tablets is considered necessary\n\nExclusion Criteria:\n\n* (1) Patients with cardiac failure or a history of cardiac failure (2) Patients with serious hepatic or renal impairment (3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) Patients with severe infection, severe trauma, or pre- and post-operative patients (5) Patients with gastrointestinal disorders such as diarrhea and vomiting (6) Pregnant or potentially pregnant women (7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides'}, 'identificationModule': {'nctId': 'NCT02098733', 'briefTitle': 'Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for in Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '097-011'}, 'secondaryIdInfos': [{'id': 'JapicCTI-142438', 'type': 'REGISTRY', 'domain': 'Japic CTI'}, {'id': 'JapicCTI-R150734', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pioglitazone/glimepiride', 'description': 'Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast', 'interventionNames': ['Drug: Pioglitazone/glimepiride']}], 'interventions': [{'name': 'Pioglitazone/glimepiride', 'type': 'DRUG', 'otherNames': ['Sonias combination tablets'], 'description': 'Pioglitazone/glimepiride combination tablets', 'armGroupLabels': ['Pioglitazone/glimepiride']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Postmarketing Group Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}