Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01193218
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2010-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Empagliflozin (BI 10773) Dose Finder Study in Japanese 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': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (12 Week)', 'description': 'Placebo once daily group in the 12-week first treatment period', 'otherNumAtRisk': 109, 'otherNumAffected': 15, 'seriousNumAtRisk': 109, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Empa 5mg (12 Week)', 'description': 'Empagliflozin 5 mg once daily group in the 12-week first treatment period', 'otherNumAtRisk': 110, 'otherNumAffected': 19, 'seriousNumAtRisk': 110, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Empa 10mg (12 Week)', 'description': 'Empagliflozin 10 mg once daily group in the 12-week first treatment period', 'otherNumAtRisk': 109, 'otherNumAffected': 16, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Empa 25mg (12 Week)', 'description': 'Empagliflozin 25 mg once daily group in the 12-week first treatment period', 'otherNumAtRisk': 109, 'otherNumAffected': 26, 'seriousNumAtRisk': 109, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Empa 50mg (12 Week)', 'description': 'Empagliflozin 50 mg once daily group in the 12-week first treatment period', 'otherNumAtRisk': 110, 'otherNumAffected': 20, 'seriousNumAtRisk': 110, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Empa 10mg (Randomized, 52 Week)', 'description': 'Patients randomized to empagliflozin 10mg once daily for 52 weeks', 'otherNumAtRisk': 109, 'otherNumAffected': 39, 'seriousNumAtRisk': 109, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Empa 25mg (Randomized, 52 Week)', 'description': 'Patients randomized to empagliflozin 25 mg once daily for 52 weeks', 'otherNumAtRisk': 109, 'otherNumAffected': 49, 'seriousNumAtRisk': 109, 'seriousNumAffected': 8}, {'id': 'EG007', 'title': 'Empa 10mg (With at Least One Dose, 52 Week)', 'description': 'Patients with at least one dose of empagliflozin 10 mg once daily for 52-week treatment', 'otherNumAtRisk': 267, 'otherNumAffected': 83, 'seriousNumAtRisk': 267, 'seriousNumAffected': 8}, {'id': 'EG008', 'title': 'Empa 25mg (With at Least One Dose, 52 Week)', 'description': 'Patients with at least one dose of empagliflozin 25 mg once daily for 52-week treatment', 'otherNumAtRisk': 265, 'otherNumAffected': 93, 'seriousNumAtRisk': 265, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 30}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 33}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 62}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 63}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 11}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 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'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'seriousEvents': [{'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, 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109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 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'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Carbohydrate antigen 19-9 increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c After 12 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (12 Week)', 'description': 'Placebo once daily group in the 12-week first treatment period'}, {'id': 'OG001', 'title': 'Empa 5mg (12 Week)', 'description': 'Empagliflozin 5 mg once daily group in the 12-week first treatment period'}, {'id': 'OG002', 'title': 'Empa 10mg (12 Week)', 'description': 'Empagliflozin 10 mg once daily group in the 12-week first treatment period'}, {'id': 'OG003', 'title': 'Empa 25mg (12 Week)', 'description': 'Empagliflozin 25 mg once daily group in the 12-week first treatment period'}, {'id': 'OG004', 'title': 'Empa 50mg (12 Week)', 'description': 'Empagliflozin 50 mg once daily group in the 12-week first treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '-0.65', 'spread': '0.09', 'groupId': 'OG003'}, {'value': '-0.61', 'spread': '0.09', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.57', 'pValueComment': 'the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Difference calculated as empa 5mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.55', 'pValueComment': 'the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Difference calculated as empa 10mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '-0.80', 'pValueComment': 'the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Difference calculated as empa 25mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.76', 'pValueComment': 'the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Difference calculated as empa 50mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate", 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Occurrence of Treat to Target Efficacy Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}, {'value': '107', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (12 Week)', 'description': 'Placebo once daily group in the 12-week first treatment period'}, {'id': 'OG001', 'title': 'Empa 5mg (12 Week)', 'description': 'Empagliflozin 5 mg once daily group in the 12-week first treatment period'}, {'id': 'OG002', 'title': 'Empa 10mg (12 Week)', 'description': 'Empagliflozin 10 mg once daily group in the 12-week first treatment period'}, {'id': 'OG003', 'title': 'Empa 25mg (12 Week)', 'description': 'Empagliflozin 25 mg once daily group in the 12-week first treatment period'}, {'id': 'OG004', 'title': 'Empa 50mg (12 Week)', 'description': 'Empagliflozin 50 mg once daily group in the 12-week first treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '8.0'}, {'value': '26.2', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '35.6'}, {'value': '19.0', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '27.9'}, {'value': '32.1', 'groupId': 'OG003', 'lowerLimit': '23.3', 'upperLimit': '41.8'}, {'value': '32.7', 'groupId': 'OG004', 'lowerLimit': '24.0', 'upperLimit': '42.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.367', 'ciLowerLimit': '5.340', 'ciUpperLimit': '70.236', 'groupDescription': 'Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.", 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.889', 'ciLowerLimit': '2.942', 'ciUpperLimit': '40.301', 'groupDescription': 'Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.624', 'ciLowerLimit': '7.601', 'ciUpperLimit': '99.99', 'estimateComment': 'The upper limit of confidence interval is actually \\>99.99', 'groupDescription': 'Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.906', 'ciLowerLimit': '12.120', 'ciUpperLimit': '99.99', 'estimateComment': 'The upper limit of confidence interval is actually \\>99.99', 'groupDescription': 'Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 12 weeks', 'description': 'Occurrence of treat to target efficacy response, that is an HbA1c of \\<7.0% after 12 weeks of treatment', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (12 Week)', 'description': 'Placebo once daily group in the 12-week first treatment period'}, {'id': 'OG001', 'title': 'Empa 5mg (12 Week)', 'description': 'Empagliflozin 5 mg once daily group in the 12-week first treatment period'}, {'id': 'OG002', 'title': 'Empa 10mg (12 Week)', 'description': 'Empagliflozin 10 mg once daily group in the 12-week first treatment period'}, {'id': 'OG003', 'title': 'Empa 25mg (12 Week)', 'description': 'Empagliflozin 25 mg once daily group in the 12-week first treatment period'}, {'id': 'OG004', 'title': 'Empa 50mg (12 Week)', 'description': 'Empagliflozin 50 mg once daily group in the 12-week first treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '4.06', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-22.65', 'spread': '2.97', 'groupId': 'OG001'}, {'value': '-25.28', 'spread': '2.77', 'groupId': 'OG002'}, {'value': '-33.70', 'spread': '2.92', 'groupId': 'OG003'}, {'value': '-32.54', 'spread': '2.97', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.70', 'ciLowerLimit': '-31.61', 'ciUpperLimit': '-21.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.50', 'groupDescription': 'Difference calculated as empa 5mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.34', 'ciLowerLimit': '-34.25', 'ciUpperLimit': '-24.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.50', 'groupDescription': 'Difference calculated as empa 10mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.75', 'ciLowerLimit': '-42.66', 'ciUpperLimit': '-32.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.50', 'groupDescription': 'Difference calculated as empa 25mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.60', 'ciLowerLimit': '-41.51', 'ciUpperLimit': '-31.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.50', 'groupDescription': 'Difference calculated as empa 50mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Change from baseline in FPG after 12 weeks of treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Confirmed Hypoglycaemic Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (12 Week)', 'description': 'Placebo once daily group in the 12-week first treatment period'}, {'id': 'OG001', 'title': 'Empa 5mg (12 Week)', 'description': 'Empagliflozin 5 mg once daily group in the 12-week first treatment period'}, {'id': 'OG002', 'title': 'Empa 10mg (12 Week)', 'description': 'Empagliflozin 10 mg once daily group in the 12-week first treatment period'}, {'id': 'OG003', 'title': 'Empa 25mg (12 Week)', 'description': 'Empagliflozin 25 mg once daily group in the 12-week first treatment period'}, {'id': 'OG004', 'title': 'Empa 50mg (12 Week)', 'description': 'Empagliflozin 50 mg once daily group in the 12-week first treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days', 'description': 'Number of patients with confirmed hypoglycaemic adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Empa 10mg', 'description': 'It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period'}, {'id': 'FG001', 'title': 'Placebo/Empa 25 mg', 'description': 'It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period'}, {'id': 'FG002', 'title': 'Empa 5mg/10mg', 'description': 'It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period'}, {'id': 'FG003', 'title': 'Empa 5 mg/25 mg', 'description': 'It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period'}, {'id': 'FG004', 'title': 'Empa 10mg', 'description': 'Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period'}, {'id': 'FG005', 'title': 'Empa 25mg', 'description': 'Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period'}, {'id': 'FG006', 'title': 'Empa 50mg\\10mg', 'description': 'It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period'}, {'id': 'FG007', 'title': 'Empa 50 mg/25 mg', 'description': 'It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period'}], 'periods': [{'title': '0-12 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'It is actually placebo group', 'groupId': 'FG000', 'numSubjects': '109'}, {'comment': 'It is actually N/A', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'It is actually empa 5mg group', 'groupId': 'FG002', 'numSubjects': '110'}, {'comment': 'It is actually N/A', 'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '109'}, {'groupId': 'FG005', 'numSubjects': '109'}, {'comment': 'It is actually empa 50mg group', 'groupId': 'FG006', 'numSubjects': '110'}, {'comment': 'It is actually N/A', 'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '108'}, {'groupId': 'FG005', 'numSubjects': '106'}, {'groupId': 'FG006', 'numSubjects': '107'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': '12-52 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '108'}, {'groupId': 'FG005', 'numSubjects': '106'}, {'groupId': 'FG006', 'numSubjects': '54'}, {'groupId': 'FG007', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '104'}, {'groupId': 'FG005', 'numSubjects': '101'}, {'groupId': 'FG006', 'numSubjects': '51'}, {'groupId': 'FG007', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Other reason than above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}, {'value': '547', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (12 Week)', 'description': 'Placebo once daily group in the 12-week first treatment period'}, {'id': 'BG001', 'title': 'Empa 5mg (12 Week)', 'description': 'Empagliflozin 5 mg once daily group in the 12-week first treatment period'}, {'id': 'BG002', 'title': 'Empa 10mg (12 Week)', 'description': 'Empagliflozin 10 mg once daily group in the 12-week first treatment period'}, {'id': 'BG003', 'title': 'Empa 25mg (12 Week)', 'description': 'Empagliflozin 25 mg once daily group in the 12-week first treatment period'}, {'id': 'BG004', 'title': 'Empa 50mg (12 Week)', 'description': 'Empagliflozin 50 mg once daily group in the 12-week first treatment period'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '57.9', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '57.2', 'spread': '9.7', 'groupId': 'BG003'}, {'value': '56.6', 'spread': '10.3', 'groupId': 'BG004'}, {'value': '57.5', 'spread': '9.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '137', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}, {'value': '410', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 547}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-16', 'studyFirstSubmitDate': '2010-08-31', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2010-08-31', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Confirmed Hypoglycaemic Adverse Events', 'timeFrame': 'between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days', 'description': 'Number of patients with confirmed hypoglycaemic adverse events'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c After 12 Weeks of Treatment.', 'timeFrame': 'baseline and 12 weeks', 'description': 'The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Treat to Target Efficacy Response', 'timeFrame': 'baseline and 12 weeks', 'description': 'Occurrence of treat to target efficacy response, that is an HbA1c of \\<7.0% after 12 weeks of treatment'}, {'measure': 'Change From Baseline in FPG', 'timeFrame': 'baseline and 12 weeks', 'description': 'Change from baseline in FPG after 12 weeks of treatment'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '38770818', 'type': 'DERIVED', 'citation': 'Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.'}, {'pmid': '35472672', 'type': 'DERIVED', 'citation': 'Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.'}, {'pmid': '28753486', 'type': 'DERIVED', 'citation': 'Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.'}, {'pmid': '25845768', 'type': 'DERIVED', 'citation': 'Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of type 2 diabetes mellitus prior to informed consent\n* Male and female patients on diet and exercise regimen who are:\n\n 1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.\n 2. pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.\n* HbA1c at Visit 1a:\n\n 1. for patients who are drug naïve: HbA1c \\>=7.0 to =\\<10.0%\n 2. for patients treated with one oral antidiabetic drug: HbA1c \\>=6.5 to =\\<9.0%\n* HbA1c of \\>=7.0% and =\\<10% at Visit 2 (start of run-in)\n\nExclusion criteria:\n\n* Uncontrolled hyperglycaemia with a glucose level \\>240 mg/dL (\\>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).\n* Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent\n* Impaired renal function, defined as calculated eGFR \\<60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.\n* Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption\n* Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)\n* Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight'}, 'identificationModule': {'nctId': 'NCT01193218', 'briefTitle': 'Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)', 'orgStudyIdInfo': {'id': '1245.38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 10773 low dose QD', 'description': 'BI 10773 tablets low dose once a day', 'interventionNames': ['Drug: Placebo (mid dose)', 'Drug: Placebo (high dose)', 'Drug: BI 10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 mid-low dose QD', 'description': 'BI 10773 tablets mid-low dose once a day', 'interventionNames': ['Drug: Placebo (high dose)', 'Drug: Placebo (low dose)', 'Drug: BI 10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 mid-high dose QD', 'description': 'BI 10773 tablets mid-high dose once a day', 'interventionNames': ['Drug: BI 10773', 'Drug: Placebo (high dose)', 'Drug: Placebo (low dose)', 'Drug: Placebo (mid dose)']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 high dose QD', 'description': 'BI 10773 tablets high dose once a day', 'interventionNames': ['Drug: Placebo (low dose)', 'Drug: Placebo (mid dose)', 'Drug: BI 10773']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets once a day', 'interventionNames': ['Drug: Placebo (low dose)', 'Drug: Placebo (high dose)', 'Drug: Placebo (mid dose)']}], 'interventions': [{'name': 'Placebo (low dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo (low dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 high dose QD']}, {'name': 'Placebo (mid dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 low dose QD']}, {'name': 'Placebo (high dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 low dose QD']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'BI 10773 tablets low dose once a day', 'armGroupLabels': ['BI 10773 low dose QD']}, {'name': 'Placebo (mid dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 high dose QD']}, {'name': 'Placebo (high dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo (high dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 mid-low dose QD']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'BI 10773 tablets mid-high dose once a day', 'armGroupLabels': ['BI 10773 mid-high dose QD']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'BI 10773 tablets high dose once a day', 'armGroupLabels': ['BI 10773 high dose QD']}, {'name': 'Placebo (mid dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo (high dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 mid-high dose QD']}, {'name': 'Placebo (low dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 mid-low dose QD']}, {'name': 'Placebo (low dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 mid-high dose QD']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'BI 10773 tablets mid-low dose once a day', 'armGroupLabels': ['BI 10773 mid-low dose QD']}, {'name': 'Placebo (mid dose)', 'type': 'DRUG', 'description': 'Placebo tablets once a day', 'armGroupLabels': ['BI 10773 mid-high dose QD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiyoda-ku, Tokyo', 'country': 'Japan', 'facility': '1245.38.016 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': '1245.38.001 Boehringer Ingelheim Investigational Site'}, {'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': '1245.38.003 Boehringer Ingelheim Investigational Site'}, {'city': 'Hachioji, Tokyo', 'country': 'Japan', 'facility': '1245.38.002 Boehringer Ingelheim Investigational Site'}, {'city': 'Hanamaki, Iwate', 'country': 'Japan', 'facility': '1245.38.010 Boehringer Ingelheim Investigational Site'}, {'city': 'Kamakura, Kanagawa', 'country': 'Japan', 'facility': '1245.38.005 Boehringer Ingelheim Investigational Site'}, {'city': 'Kanazawa, Ishikawa', 'country': 'Japan', 'facility': '1245.38.020 Boehringer Ingelheim Investigational Site'}, {'city': 'Kashiwa, Chiba', 'country': 'Japan', 'facility': '1245.38.013 Boehringer Ingelheim Investigational Site'}, {'city': 'Katsushika-ku, Tokyo', 'country': 'Japan', 'facility': '1245.38.019 Boehringer Ingelheim Investigational Site'}, {'city': 'Kyoto, Kyoto', 'country': 'Japan', 'facility': '1245.38.021 Boehringer Ingelheim Investigational Site'}, {'city': 'Matsuyama, Ehime', 'country': 'Japan', 'facility': '1245.38.024 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Minato-ku, Tokyo', 'country': 'Japan', 'facility': '1245.38.004 Boehringer Ingelheim Investigational Site'}, {'city': 'Moriya, Ibaraki', 'country': 'Japan', 'facility': '1245.38.011 Boehringer Ingelheim Investigational Site'}, {'city': 'Naha, Okinawa', 'country': 'Japan', 'facility': '1245.38.030 Boehringer Ingelheim Investigational Site'}, {'city': 'Okawa, Fukuoka', 'country': 'Japan', 'facility': '1245.38.032 Boehringer Ingelheim Investigational Site'}, {'city': 'Okinawa, Okinawa', 'country': 'Japan', 'facility': '1245.38.031 Boehringer Ingelheim Investigational Site'}, {'city': 'Saga, Saga', 'country': 'Japan', 'facility': '1245.38.025 Boehringer Ingelheim Investigational Site'}, {'city': 'Saitama, Saitama', 'country': 'Japan', 'facility': '1245.38.014 Boehringer Ingelheim Investigational Site'}, {'city': 'Sapporo, Hokkaido', 'country': 'Japan', 'facility': '1245.38.006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo, Hokkaido', 'country': 'Japan', 'facility': '1245.38.007 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo, Hokkaido', 'country': 'Japan', 'facility': '1245.38.008 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo, Hokkaido', 'country': 'Japan', 'facility': '1245.38.009 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sasima-gun, Ibaraki', 'country': 'Japan', 'facility': '1245.38.012 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Shinjuku-ku, Tokyo', 'country': 'Japan', 'facility': '1245.38.015 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Shinjuku-ku, Tokyo', 'country': 'Japan', 'facility': '1245.38.018 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Suginami-ku, Tokyo', 'country': 'Japan', 'facility': '1245.38.017 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Suita, Osaka', 'country': 'Japan', 'facility': '1245.38.022 Boehringer Ingelheim Investigational Site'}, {'city': 'Ube, Yamaguchi', 'country': 'Japan', 'facility': '1245.38.023 Boehringer Ingelheim Investigational Site'}, {'city': 'Urasoe, Okinawa', 'country': 'Japan', 'facility': '1245.38.026 Boehringer Ingelheim Investigational Site'}, {'city': 'Urasoe, Okinawa', 'country': 'Japan', 'facility': '1245.38.027 Boehringer Ingelheim Investigational Site'}, {'city': 'Urasoe, Okinawa', 'country': 'Japan', 'facility': '1245.38.028 Boehringer Ingelheim Investigational Site'}, {'city': 'Urasoe, Okinawa', 'country': 'Japan', 'facility': '1245.38.029 Boehringer Ingelheim Investigational Site'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}