Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-13 @ 4:28 AM
Study NCT ID:
NCT02414958
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune 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'}, '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': 'From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days', 'description': 'Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 243, 'otherNumAffected': 197, 'seriousNumAtRisk': 243, 'deathsNumAffected': 0, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 243, 'otherNumAffected': 197, 'seriousNumAtRisk': 243, 'deathsNumAffected': 0, 'seriousNumAffected': 43}, {'id': 'EG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.', 'otherNumAtRisk': 244, 'deathsNumAtRisk': 244, 'otherNumAffected': 195, 'seriousNumAtRisk': 244, 'deathsNumAffected': 0, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood ketone body increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 152}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 154}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 147}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Normal tension glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pleurisy viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia klebsiella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Shunt malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood ketone body increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Clostridium test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetic metabolic decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ketosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lacunar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Radicular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acquired phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Menstrual disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 244, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.54', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '-0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'Model Mixed effect Model Repeated Measures (MMRM) included the fixed categorical effects of treatment, pre-existing insulin therapy, visit , and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline estimated glomerular filtration rate (eGFR), and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'Mixed effect Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.53', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '-0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean', 'groupDescription': 'Model MMRM included the fixed categorical effects of treatment, pre-existing insulin therapy, visit, and treatment-by- visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline eGFR, and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases \\[OC\\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.", 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) (observed cases \\[OC\\]): Patients in the Treated Set (TS) who had a baseline and at least 1 on-treatment HbA1c measurement; the FAS was the basis for the primary efficacy analysis'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.53', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '-0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.51', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '-0.39', 'estimateComment': 'Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data \\[OC-AD\\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.", 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention-to-treat set (mITT) (observed case - all data \\[OC-AD\\]): Patients in the TS who had a baseline and at least 1 post-baseline HbA1c measurement.'}, {'type': 'SECONDARY', 'title': 'Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'classes': [{'title': 'Week 5 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.92', 'groupId': 'OG000', 'lowerLimit': '7.15', 'upperLimit': '11.14'}, {'value': '6.64', 'groupId': 'OG001', 'lowerLimit': '5.32', 'upperLimit': '8.28'}, {'value': '6.48', 'groupId': 'OG002', 'lowerLimit': '5.18', 'upperLimit': '8.12'}]}]}, {'title': 'Week 1 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.13', 'groupId': 'OG000', 'lowerLimit': '7.36', 'upperLimit': '11.34'}, {'value': '7.07', 'groupId': 'OG001', 'lowerLimit': '5.70', 'upperLimit': '8.76'}, {'value': '7.15', 'groupId': 'OG002', 'lowerLimit': '5.75', 'upperLimit': '8.88'}]}]}], 'analyses': [{'pValue': '0.0623', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Rate Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.75', 'paramValue': '0.744', 'ciLowerLimit': '0.518', 'ciUpperLimit': '1.069', 'estimateComment': 'Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.', 'groupDescription': 'For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \\[days\\]) was used as offset.', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0480', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Rate Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.75', 'paramValue': '0.726', 'ciLowerLimit': '0.502', 'ciUpperLimit': '1.501', 'estimateComment': 'Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.', 'groupDescription': 'For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \\[days\\]) was used as offset', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Rate Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.774', 'ciLowerLimit': '0.572', 'ciUpperLimit': '1.048', 'pValueComment': 'This is a nominal p-value.', 'estimateComment': 'Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.', 'groupDescription': 'For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \\[days\\]) was used as offset.', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1180', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Rate Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.75', 'paramValue': '0.782', 'ciLowerLimit': '0.575', 'ciUpperLimit': '1.064', 'pValueComment': 'Negative binomial model', 'estimateComment': 'Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.', 'groupDescription': 'For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \\[days\\]) was used as offset.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 5 to Week 26, Week 1 to Week 26', 'description': 'This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) \\<54 milligram per deciliter (mg/dL) (\\<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG \\<54 mg/dL \\[\\<3.0 mmol/L\\] with symptoms reported and all severe hypoglycaemia events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate.', 'unitOfMeasure': 'Event per patient year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (OC)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-2.79', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-3.37', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-2.69', 'ciLowerLimit': '-3.57', 'ciUpperLimit': '-1.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'estimateComment': 'Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-3.27', 'ciLowerLimit': '-4.15', 'ciUpperLimit': '-2.39', 'estimateComment': 'Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in body weight is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.", 'unitOfMeasure': 'Kilogram (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (OC)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.13', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '10.73', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '11.74', 'spread': '0.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '11.86', 'ciLowerLimit': '8.78', 'ciUpperLimit': '14.93', 'estimateComment': 'Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean', 'groupDescription': 'The analysis of covariance (ANCOVA) model includes baseline time in the target range, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '12.87', 'ciLowerLimit': '9.81', 'ciUpperLimit': '15.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.01', 'estimateComment': 'Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 23 to 26', 'description': 'Change from baseline in the percentage of time spent in target glucose range of \\>70 to ≤180 mg/dL (\\>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS observed cases excluding data after use of paracetamol (OC-P)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.62', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-15.30', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '-17.41', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-16.92', 'ciLowerLimit': '-22.04', 'ciUpperLimit': '-11.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.68', 'estimateComment': 'Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-19.04', 'ciLowerLimit': '-24.13', 'ciUpperLimit': '-13.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.68', 'estimateComment': 'Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 23 to 26', 'description': 'Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate.', 'unitOfMeasure': 'milligrams (mg)/ deciliter (dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS observed cases excluding data after use of paracetamol (OC-P)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.007', 'groupId': 'OG000'}, {'value': '-0.102', 'spread': '0.007', 'groupId': 'OG001'}, {'value': '-0.100', 'spread': '0.007', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-0.092', 'ciLowerLimit': '-0.121', 'ciUpperLimit': '-0.063', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.009', 'estimateComment': 'Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-0.090', 'ciLowerLimit': '-0.119', 'ciUpperLimit': '-0.062', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.009', 'estimateComment': 'Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.", 'unitOfMeasure': 'Unit/kilogram (U/kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (OC)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'classes': [{'title': 'SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0397', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-2.1', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0', 'estimateComment': 'Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'For SBP, the model MMRM includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-3.7', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0', 'estimateComment': 'Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'For SBP, the model includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0457', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-1.3', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '0.0', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'estimateComment': 'Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'For DBP, the model MMRM includes baseline DBP seated, baseline eGFR baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.75', 'paramValue': '-2.3', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'estimateComment': 'Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.', 'groupDescription': 'For DBP, the model MMRM includes baseline DBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.", 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS observed cases excluding data after change in use of anti-hypertensives (OC-H)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'FG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'FG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '243'}, {'groupId': 'FG002', 'numSubjects': '244'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '223'}, {'groupId': 'FG002', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Randomised, double-blind, placebo-controlled, parallel group, 52-week trial comparing 2 oral once daily doses (10 mg and 25 mg) of empagliflozin with placebo in patients with type 1 diabetes mellitus (T1DM), each as adjunctive to optimised insulin therapy.', 'preAssignmentDetails': '6-week T1DM therapy (insulin) optimisation period followed by a 2-week placebo run-in period before randomisation. Patients who successfully completed both of the periods were randomised into the 52-week double-blind treatment period. All treatments were administered in addition to optimised insulin therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '730', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Matching Empagliflozin', 'description': 'Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks'}, {'id': 'BG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'BG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '45.7', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '14.0', 'groupId': 'BG002'}, {'value': '45.0', 'spread': '13.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'RS'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '389', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '341', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'RS'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}, {'value': '713', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'RS'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '687', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'RS'}], 'populationDescription': 'Randomised set (RS): All patients from the screened set (SCR) who were randomised to trial medication regardless of whether any trial medication was taken.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-04', 'size': 1034634, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-21T13:25', 'hasProtocol': True}, {'date': '2017-11-08', 'size': 378991, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-21T13:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 730}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2018-04-10', 'completionDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2015-04-08', 'dispFirstSubmitQcDate': '2018-04-10', 'resultsFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2015-04-08', 'dispFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-22', 'studyFirstPostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases \\[OC\\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects."}, {'measure': 'Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) )', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data \\[OC-AD\\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects."}], 'secondaryOutcomes': [{'measure': 'Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG)', 'timeFrame': 'Week 5 to Week 26, Week 1 to Week 26', 'description': 'This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) \\<54 milligram per deciliter (mg/dL) (\\<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG \\<54 mg/dL \\[\\<3.0 mmol/L\\] with symptoms reported and all severe hypoglycaemia events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate.'}, {'measure': 'Change From Baseline in Body Weight at Week 26', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in body weight is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline."}, {'measure': 'Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26', 'timeFrame': 'Week 23 to 26', 'description': 'Change from baseline in the percentage of time spent in target glucose range of \\>70 to ≤180 mg/dL (\\>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate.'}, {'measure': 'Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26', 'timeFrame': 'Week 23 to 26', 'description': 'Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate.'}, {'measure': 'Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline."}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26', 'timeFrame': 'Baseline to week 26', 'description': "Change from baseline in SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline."}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '37616393', 'type': 'DERIVED', 'citation': 'Song C, Dhaliwal S, Bapat P, Scarr D, Bakhsh A, Budhram D, Verhoeff NJ, Weisman A, Fralick M, Ivers NM, Cherney DZI, Tomlinson G, Lovblom LE, Mumford D, Perkins BA. Point-of-Care Capillary Blood Ketone Measurements and the Prediction of Future Ketoacidosis Risk in Type 1 Diabetes. Diabetes Care. 2023 Nov 1;46(11):1973-1977. doi: 10.2337/dc23-0840.'}, {'pmid': '30287422', 'type': 'DERIVED', 'citation': 'Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Male or female patient receiving insulin for the treatment of documented diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1\n* Fasting C-peptide value of \\< 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory\n* Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either:\n\n * Multiple Daily Injections (MDI) of insulin consisting of at least one basal insulin injection and at least three daily bolus injections OR\n * Continuous Subcutaneous Insulin Infusion (CSII) of any insulin type, with at least 5 months experience of using CSII prior to Visit 1\n* HbA1c \\>/= 7.5% and \\</= 10.0% at Visit 5 measured by the central laboratory\n* Age \\>/= 18 years at Visit 1\n\nAdditional inclusion criteria may apply\n\nExclusion criteria:\n\n* History of Type 2 Diabetes Mellitus (T2DM), maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis\n* Pancreas, pancreatic islet cells or renal transplant recipient\n* T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, Glucagon-like-peptide 1 (GLP-1) analogues, Sodium-Glucose Co-Transporter (SGLT-2) inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1\n* Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1 and until randomisation\n* Occurence of Diabetic Ketoacidosis (DKA) within 3 months prior to Visit 1 and until randomisation\n\nAdditional exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT02414958', 'briefTitle': 'Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to inSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)', 'orgStudyIdInfo': {'id': '1245.69'}, 'secondaryIdInfos': [{'id': '2014-001922-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin low dose', 'description': 'Empagliflozin tablets once daily', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Empagliflozin high dose', 'description': 'Empagliflozin tablets once daily', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets matching empagliflozin once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'armGroupLabels': ['Empagliflozin low dose']}, {'name': 'Empagliflozin', 'type': 'DRUG', 'armGroupLabels': ['Empagliflozin high dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute, Inc.', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes/Lipid Management and Research Center', 'geoPoint': {'lat': 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