Viewing Study NCT01719003

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Ignite Creation Date: 2025-12-24 @ 7:12 PM
Ignite Modification Date: 2025-12-26 @ 5:41 PM
Study NCT ID: NCT01719003
Status: COMPLETED
Last Update Posted: 2016-02-19
First Post: 2012-10-30
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India', 'Indonesia', 'United Arab Emirates']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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': 'D008687', 'term': 'Metformin'}, {'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'C570240', 'term': 'empagliflozin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'phoneExt': '+1', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)', 'otherNumAtRisk': 170, 'otherNumAffected': 48, 'seriousNumAtRisk': 170, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid', 'otherNumAtRisk': 170, 'otherNumAffected': 40, 'seriousNumAtRisk': 170, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Empagliflozin 5 mg Bid + Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid', 'otherNumAtRisk': 171, 'otherNumAffected': 35, 'seriousNumAtRisk': 171, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Empagliflozin 5 mg Bid + Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid', 'otherNumAtRisk': 169, 'otherNumAffected': 42, 'seriousNumAtRisk': 169, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Empagliflozin 25 mg qd', 'description': 'Oral administration of Empagliflozin 25 mg once daily (qd)', 'otherNumAtRisk': 167, 'otherNumAffected': 41, 'seriousNumAtRisk': 167, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Empagliflozin 10 mg qd', 'description': 'Oral administration of Empagliflozin 10 mg qd', 'otherNumAtRisk': 172, 'otherNumAffected': 36, 'seriousNumAtRisk': 172, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Metformin 1000 mg Bid', 'description': 'Oral administration of Metformin 1000 mg bid', 'otherNumAtRisk': 170, 'otherNumAffected': 53, 'seriousNumAtRisk': 170, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Metformin 500 mg Bid', 'description': 'Oral administration of Metformin 500 mg bid', 'otherNumAtRisk': 171, 'otherNumAffected': 38, 'seriousNumAtRisk': 171, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)', 'otherNumAtRisk': 53, 'otherNumAffected': 16, 'seriousNumAtRisk': 53, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 24}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 10}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 12}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Herpes simplex encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}, {'value': '143', 'groupId': 'OG004'}, {'value': '156', 'groupId': 'OG005'}, {'value': '146', 'groupId': 'OG006'}, {'value': '142', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)'}, {'id': 'OG001', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid'}, {'id': 'OG002', 'title': 'Empagliflozin 5 mg Bid + Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid'}, {'id': 'OG003', 'title': 'Empagliflozin 5 mg Bid + Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid'}, {'id': 'OG004', 'title': 'Empagliflozin 25 mg qd', 'description': 'Oral administration of Empagliflozin 25 mg once daily (qd)'}, {'id': 'OG005', 'title': 'Empagliflozin 10 mg qd', 'description': 'Oral administration of Empagliflozin 10 mg qd'}, {'id': 'OG006', 'title': 'Metformin 1000 mg Bid', 'description': 'Oral administration of Metformin 1000 mg bid'}, {'id': 'OG007', 'title': 'Metformin 500 mg Bid', 'description': 'Oral administration of Metformin 500 mg bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.08', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-2.07', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '-1.98', 'spread': '0.08', 'groupId': 'OG003'}, {'value': '-1.36', 'spread': '0.08', 'groupId': 'OG004'}, {'value': '-1.35', 'spread': '0.08', 'groupId': 'OG005'}, {'value': '-1.75', 'spread': '0.09', 'groupId': 'OG006'}, {'value': '-1.18', 'spread': '0.08', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0056', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 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'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '-0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '0.0062', 'groupIds': ['OG002', 'OG006'], 'paramType': 'Adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'Empagliflozin 5 mg bid + 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bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Adjusted Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.7', 'ciLowerLimit': '-33.5', 'ciUpperLimit': '-20.0', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.4', 'estimateComment': 'Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.0', 'ciLowerLimit': '-22.8', 'ciUpperLimit': '-9.2', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.4', 'estimateComment': 'Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG006'], 'paramType': 'Adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.6', 'ciLowerLimit': '-22.3', 'ciUpperLimit': '-8.9', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.4', 'estimateComment': 'Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG of double-blind treatment', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Adjusted Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.8', 'ciLowerLimit': '-21.4', 'ciUpperLimit': '-8.2', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.4', 'estimateComment': 'Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG007'], 'paramType': 'Adjusted Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.2', 'ciLowerLimit': '-35.0', 'ciUpperLimit': '-21.5', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.4', 'estimateComment': 'Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-19.1', 'ciUpperLimit': '-6.0', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.4', 'estimateComment': 'Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS observed cases (OC) (Only patients with available data are analysed)'}, {'type': 'SECONDARY', 'title': 'Body Weight Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}, {'value': '143', 'groupId': 'OG004'}, {'value': '155', 'groupId': 'OG005'}, {'value': '148', 'groupId': 'OG006'}, {'value': '140', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)'}, {'id': 'OG001', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid'}, {'id': 'OG002', 'title': 'Empagliflozin 5 mg Bid + Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid'}, {'id': 'OG003', 'title': 'Empagliflozin 5 mg Bid + Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid'}, {'id': 'OG004', 'title': 'Empagliflozin 25 mg qd', 'description': 'Oral administration of Empagliflozin 25 mg once daily (qd)'}, {'id': 'OG005', 'title': 'Empagliflozin 10 mg qd', 'description': 'Oral administration of Empagliflozin 10 mg qd'}, {'id': 'OG006', 'title': 'Metformin 1000 mg Bid', 'description': 'Oral administration of Metformin 1000 mg bid'}, {'id': 'OG007', 'title': 'Metformin 500 mg Bid', 'description': 'Oral administration of Metformin 500 mg bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.78', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-3.04', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-3.48', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '-2.77', 'spread': '0.30', 'groupId': 'OG003'}, {'value': '-2.38', 'spread': '0.30', 'groupId': 'OG004'}, {'value': '-2.39', 'spread': '0.29', 'groupId': 'OG005'}, {'value': '-1.27', 'spread': '0.30', 'groupId': 'OG006'}, {'value': '-0.52', 'spread': '0.30', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.50', 'ciLowerLimit': '-3.33', 'ciUpperLimit': '-1.68', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'estimateComment': 'Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Adjusted Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.52', 'ciLowerLimit': '-3.35', 'ciUpperLimit': '-1.69', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'estimateComment': 'Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG006'], 'paramType': 'Adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.20', 'ciLowerLimit': '-3.03', 'ciUpperLimit': '-1.37', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'estimateComment': 'Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG007'], 'paramType': 'Adjusted Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.26', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '-1.43', 'pValueComment': 'Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'estimateComment': 'Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid', 'groupDescription': 'Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \\& 'visit by treatment interaction':fixed effects.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS observed cases (OC) (Only patients with available data are analysed)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)'}, {'id': 'FG001', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid'}, {'id': 'FG002', 'title': 'Empagliflozin 5 mg Bid + Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid'}, {'id': 'FG003', 'title': 'Empagliflozin 5 mg Bid + Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid'}, {'id': 'FG004', 'title': 'Empagliflozin 25 mg qd', 'description': 'Oral administration of Empagliflozin 25 mg once daily (qd)'}, {'id': 'FG005', 'title': 'Empagliflozin 10 mg qd', 'description': 'Oral administration of Empagliflozin 10 mg qd'}, {'id': 'FG006', 'title': 'Metformin 1000 mg Bid', 'description': 'Oral administration of Metformin 1000 mg bid'}, {'id': 'FG007', 'title': 'Metformin 500 mg Bid', 'description': 'Oral administration of Metformin 500 mg bid'}, {'id': 'FG008', 'title': 'Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '170'}, {'groupId': 'FG002', 'numSubjects': '171'}, {'groupId': 'FG003', 'numSubjects': '169'}, {'groupId': 'FG004', 'numSubjects': '167'}, {'groupId': 'FG005', 'numSubjects': '172'}, {'groupId': 'FG006', 'numSubjects': '170'}, {'groupId': 'FG007', 'numSubjects': '171'}, {'groupId': 'FG008', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '154'}, {'groupId': 'FG003', 'numSubjects': '156'}, {'groupId': 'FG004', 'numSubjects': '150'}, {'groupId': 'FG005', 'numSubjects': '160'}, {'groupId': 'FG006', 'numSubjects': '150'}, {'groupId': 'FG007', 'numSubjects': '151'}, {'groupId': 'FG008', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '20'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Non compliant with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}]}, {'type': 'Refusal to continue, not due to AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Reason other than those specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'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'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'With the first global protocol amendment (13-Dec-2012), the HbA1c inclusion criterion changed and further enrolment in the open label (OL) group was stopped, but the patients already entered in the OL group could continue until the scheduled end of the study.', 'preAssignmentDetails': 'Patients with an (Glycosylated Haemoglobin) HbA1c \\>10.0% at screening and meeting all other inclusion criteria were initially directly included in an OL treatment group'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}, {'value': '169', 'groupId': 'BG005'}, {'value': '164', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}, {'value': '1327', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)'}, {'id': 'BG001', 'title': 'Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid'}, {'id': 'BG002', 'title': 'Empagliflozin 5 mg Bid + Metformin 1000 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid'}, {'id': 'BG003', 'title': 'Empagliflozin 5 mg Bid + Metformin 500 mg Bid', 'description': 'Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid'}, {'id': 'BG004', 'title': 'Empagliflozin 25 mg qd', 'description': 'Oral administration of Empagliflozin 25 mg once daily (qd)'}, {'id': 'BG005', 'title': 'Empagliflozin 10 mg qd', 'description': 'Oral administration of Empagliflozin 10 mg qd'}, {'id': 'BG006', 'title': 'Metformin 1000 mg Bid', 'description': 'Oral administration of Metformin 1000 mg bid'}, {'id': 'BG007', 'title': 'Metformin 500 mg Bid', 'description': 'Oral administration of Metformin 500 mg bid'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '52.3', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '52.2', 'spread': '11.7', 'groupId': 'BG003'}, {'value': '53.3', 'spread': '10.7', 'groupId': 'BG004'}, {'value': '53.1', 'spread': '10.7', 'groupId': 'BG005'}, {'value': '51.6', 'spread': '10.8', 'groupId': 'BG006'}, {'value': '53.4', 'spread': '10.9', 'groupId': 'BG007'}, {'value': '52.6', 'spread': '10.9', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}, {'value': '82', 'groupId': 'BG007'}, {'value': '580', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}, {'value': '97', 'groupId': 'BG005'}, {'value': '92', 'groupId': 'BG006'}, {'value': '86', 'groupId': 'BG007'}, {'value': '747', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS): FAS comprised all randomised patients treated with at least 1 dose of trial medication, with a baseline and at least 1 on-treatment HbA1c assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1413}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-22', 'studyFirstSubmitDate': '2012-10-30', 'resultsFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2012-10-30', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-22', 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means'}], 'secondaryOutcomes': [{'measure': 'FPG (Fasting Plasma Glucose) Change From Baseline at Week 24', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.'}, {'measure': 'Body Weight Change From Baseline at Week 24', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '27493136', 'type': 'DERIVED', 'citation': 'Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Diagnosis of type 2 diabetes mellitus prior to informed consent\n2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization\n3. HbA1c \\>=7.5% and \\<= 12% (\\>=58.5 mmol/mol and \\<=107.7 mmol/mol)\n4. Body Mass Index (BMI) \\<= 45 kg/m2 at screening\n\nExclusion criteria:\n\n1. Uncontrolled hyperglycemia with a glucose level \\>240 mg/dl (\\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)\n2. Any antidiabetic drug within 12 weeks prior to randomization\n3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) \\<60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period\n4. Contraindications to metformin according to the local label'}, 'identificationModule': {'nctId': 'NCT01719003', 'briefTitle': 'Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1276.1'}, 'secondaryIdInfos': [{'id': '2010-021375-92', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin low dose qd', 'description': 'Empagliflozin low dose once daily', 'interventionNames': ['Drug: Empagliflozin low dose qd']}, {'type': 'EXPERIMENTAL', 'label': 'Empagliflozin high dose qd', 'description': 'Empagliflozin high dose once daily', 'interventionNames': ['Drug: Empagliflozin high dose qd']}, {'type': 'EXPERIMENTAL', 'label': 'OL empa high dose + met 1000 mg bid', 'description': 'Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. 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