Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT01924767
Status:
COMPLETED
Last Update Posted:
2014-07-04
First Post:
2013-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'day1 to day21', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.', 'otherNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.', 'otherNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.', 'otherNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.', 'otherNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.', 'otherNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Injection site thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'Investigations: Hepatic enzyme increased', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 1 to day 21', 'description': 'Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Clinically relevant', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'Clinically irrelevant', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 1 to day 21', 'description': 'Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'PRIMARY', 'title': 'Micturition Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Micturition day frequency', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '4.4', 'spread': '2.1', 'groupId': 'OG004'}]}]}, {'title': 'Micturition night frequency', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG004'}]}]}, {'title': 'Micturition total frequency', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '2.4', 'groupId': 'OG003'}, {'value': '5.1', 'spread': '2.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 9', 'description': 'Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.', 'unitOfMeasure': 'frequency of micturition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'PRIMARY', 'title': 'Assessment of Tolerability by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Good', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'Not satisfactory', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'Bad', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 21', 'description': 'Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Concentration of the Analyte in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Cmax after first dose', 'categories': [{'measurements': [{'value': '61.3', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '240', 'spread': '21.2', 'groupId': 'OG001'}, {'value': '592', 'spread': '23.7', 'groupId': 'OG002'}, {'value': '2670', 'spread': '26.1', 'groupId': 'OG003'}]}]}, {'title': 'Cmax at steady-state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '66.6', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '272', 'spread': '30.1', 'groupId': 'OG001'}, {'value': '622', 'spread': '17.4', 'groupId': 'OG002'}, {'value': '2700', 'spread': '20.9', 'groupId': 'OG003'}]}]}, {'title': 'Cmin at steady-state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '4.41', 'spread': '36.9', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '31.5', 'groupId': 'OG001'}, {'value': '47.1', 'spread': '35.3', 'groupId': 'OG002'}, {'value': '243', 'spread': '32.0', 'groupId': 'OG003'}]}]}, {'title': 'Cavg at steady-state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '19.2', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '83.5', 'spread': '17.4', 'groupId': 'OG001'}, {'value': '204', 'spread': '21.5', 'groupId': 'OG002'}, {'value': '922', 'spread': '28.7', 'groupId': 'OG003'}]}]}, {'title': 'C24,8 (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '4.55', 'spread': '36.8', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '31.7', 'groupId': 'OG001'}, {'value': '47.2', 'spread': '35.2', 'groupId': 'OG002'}, {'value': '249', 'spread': '27.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric Mean of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.661', 'ciLowerLimit': '27.520', 'ciUpperLimit': '69.269', 'groupDescription': 'This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax (single dose) was analysed.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric Mean of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.234', 'ciLowerLimit': '12.193', 'ciUpperLimit': '80.011', 'groupDescription': 'This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax,ss (Multiple dose) was analysed.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Maximum concentration of the analyte in plasma (Cmax) after first dose, Maximum, minimum (Cmin) and average (Cavg) concentration of the analyte in plasma at steady-state, Concentration of analyte in plasma at 24 h after administration of the 8th dose (at steady-state) (C24,8)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PK set) contains of all patients who received study medication and have evaluable pharmacokinetic parameter data. The PK set will not contain placebo patients.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'AUC0-∞ after first dose', 'categories': [{'measurements': [{'value': '468', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '1890', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '4780', 'spread': '23.7', 'groupId': 'OG002'}, {'value': '23300', 'spread': '19.4', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-24 after first dose', 'categories': [{'measurements': [{'value': '397', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '1620', 'spread': '13.5', 'groupId': 'OG001'}, {'value': '4200', 'spread': '23.6', 'groupId': 'OG002'}, {'value': '19700', 'spread': '17.6', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-tau at steady state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '460', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '2000', 'spread': '17.4', 'groupId': 'OG001'}, {'value': '4890', 'spread': '21.5', 'groupId': 'OG002'}, {'value': '22100', 'spread': '28.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.707', 'ciLowerLimit': '33.490', 'ciUpperLimit': '73.776', 'groupDescription': 'This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, single dose) was analysed.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.632', 'ciLowerLimit': '15.429', 'ciUpperLimit': '91.789', 'groupDescription': 'This was non confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, at steady state, day 9) was analysed.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'AUC0-∞: from 0 extrapolated to infinity after first dose AUCtau,1: over a uniform dosing interval tau after first dose AUCtau,ss: over a uniform dosing interval tau at steady-state AUCs were computed using the linear up/log down algorithm. If an analyte concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was to be used. If the analyte concentration was smaller than the preceding concentration, the logarithmic method was to be used.', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration of the Analyte in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'tmax after first dose', 'categories': [{'measurements': [{'value': '1.50', 'spread': '27.5', 'groupId': 'OG000', 'lowerLimit': '0.667', 'upperLimit': '1.50'}, {'value': '1.50', 'spread': '18.2', 'groupId': 'OG001', 'lowerLimit': '0.983', 'upperLimit': '2.00'}, {'value': '1.50', 'spread': '38.5', 'groupId': 'OG002', 'lowerLimit': '0.983', 'upperLimit': '4.00'}, {'value': '3.00', 'spread': '77.8', 'groupId': 'OG003', 'lowerLimit': '0.983', 'upperLimit': '4.00'}]}]}, {'title': 'tmax at steady-state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '1.50', 'spread': '27.4', 'groupId': 'OG000', 'lowerLimit': '0.983', 'upperLimit': '2.00'}, {'value': '1.50', 'spread': '24.3', 'groupId': 'OG001', 'lowerLimit': '0.983', 'upperLimit': '2.00'}, {'value': '2.00', 'spread': '62.6', 'groupId': 'OG002', 'lowerLimit': '0.667', 'upperLimit': '4.20'}, {'value': '1.50', 'spread': '62.3', 'groupId': 'OG003', 'lowerLimit': '0.983', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Time from last dosing to maximum concentration of the analyte in plasma (tmax) after first dose and at steady-state', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Terminal Rate Constant in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Terminal rate after first dose', 'categories': [{'measurements': [{'value': '0.0618', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '0.0586', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '0.0654', 'spread': '19.9', 'groupId': 'OG002'}, {'value': '0.0527', 'spread': '26.8', 'groupId': 'OG003'}]}]}, {'title': 'Terminal rate at steady-state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '0.0686', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '0.0491', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '0.0658', 'spread': '18.8', 'groupId': 'OG002'}, {'value': '0.0409', 'spread': '48.4', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Terminal rate constant in plasma after first dose and at steady-state', 'unitOfMeasure': '1/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Half-life and Mean Residence Time of the Analyte in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 't1/2 after first dose', 'categories': [{'measurements': [{'value': '11.2', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '19.9', 'groupId': 'OG002'}, {'value': '13.2', 'spread': '26.8', 'groupId': 'OG003'}]}]}, {'title': 't1/2 at steady state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '10.1', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '18.8', 'groupId': 'OG002'}, {'value': '17.0', 'spread': '48.4', 'groupId': 'OG003'}]}]}, {'title': 'MRT po after first dose', 'categories': [{'measurements': [{'value': '12.2', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '13.5', 'groupId': 'OG002'}, {'value': '12.7', 'spread': '19.7', 'groupId': 'OG003'}]}]}, {'title': 'MRT po at steady-state (9,8,9,8)', 'categories': [{'measurements': [{'value': '10.7', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '22.7', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '13.7', 'groupId': 'OG002'}, {'value': '14.6', 'spread': '20.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Terminal half life of the analyte in plasma (t1/2) and mean residence time of the analyte in the body after single oral administration (MRTpo) after first dose and at steady-state.', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Set'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution During the Terminal Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Vz/F after first dose', 'categories': [{'measurements': [{'value': '192', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '200', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '177', 'spread': '27.9', 'groupId': 'OG002'}, {'value': '181', 'spread': '35.1', 'groupId': 'OG003'}]}]}, {'title': 'Vz/F at steady state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '176', 'spread': '25.0', 'groupId': 'OG000'}, {'value': '225', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '172', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '245', 'spread': '56.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Apparent volume of distribution during the terminal phase (Vz/F) after first dose and at steady state. Apparent volume is defined as CL/F divided by the terminal rate constant in plasma (either after first dose or at steady-state).', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Amount of Analyte Eliminated in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Ae0-48 after first dose', 'categories': [{'measurements': [{'value': '706', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '2570', 'spread': '42.2', 'groupId': 'OG001'}, {'value': '5250', 'spread': '52.0', 'groupId': 'OG002'}, {'value': '18500', 'spread': '32.7', 'groupId': 'OG003'}]}]}, {'title': 'Ae0-48 at steady-state (N=9,8,8,9)', 'categories': [{'measurements': [{'value': '941', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '4530', 'spread': '23.5', 'groupId': 'OG001'}, {'value': '8450', 'spread': '42.7', 'groupId': 'OG002'}, {'value': '22400', 'spread': '145', 'groupId': 'OG003'}]}]}, {'title': 'Ae0-24 after first dose', 'categories': [{'measurements': [{'value': '613', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '2250', 'spread': '42.7', 'groupId': 'OG001'}, {'value': '4770', 'spread': '54.6', 'groupId': 'OG002'}, {'value': '16600', 'spread': '34.3', 'groupId': 'OG003'}]}]}, {'title': 'Ae0-24 at steady-state (N=9,8,8,9)', 'categories': [{'measurements': [{'value': '820', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '4040', 'spread': '26.7', 'groupId': 'OG001'}, {'value': '7520', 'spread': '43.6', 'groupId': 'OG002'}, {'value': '19300', 'spread': '153', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9', 'description': 'Amount of analyte that is eliminated in urine after first dose and at steady state from the time interval 0 to 24 h (Ae0-24) and 0 to 48 h (Ae0-48)', 'unitOfMeasure': 'nmol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Fraction of Analyte Excreted Unchanged in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'fe0-12 after first dose', 'categories': [{'measurements': [{'value': '8.50', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '8.43', 'spread': '39.8', 'groupId': 'OG001'}, {'value': '6.30', 'spread': '78.2', 'groupId': 'OG002'}, {'value': '6.17', 'spread': '37.6', 'groupId': 'OG003'}]}]}, {'title': 'fe0-12 at steady-state (N=9,8,8,9)', 'categories': [{'measurements': [{'value': '10.6', 'spread': '47.0', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '26.5', 'groupId': 'OG001'}, {'value': '9.22', 'spread': '54.0', 'groupId': 'OG002'}, {'value': '6.68', 'spread': '154', 'groupId': 'OG003'}]}]}, {'title': 'fe0-24 after first dose', 'categories': [{'measurements': [{'value': '11.1', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '42.7', 'groupId': 'OG001'}, {'value': '7.38', 'spread': '73.0', 'groupId': 'OG002'}, {'value': '7.48', 'spread': '34.3', 'groupId': 'OG003'}]}]}, {'title': 'fe0-24 at steady-state (N=9,8,8,9)', 'categories': [{'measurements': [{'value': '14.8', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '26.7', 'groupId': 'OG001'}, {'value': '11.4', 'spread': '53.6', 'groupId': 'OG002'}, {'value': '8.71', 'spread': '153', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9', 'description': 'Fraction of analyte excreted unchanged in urine in the time interval 0 to 12 h (fe0-12) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-12 by the Dose and multiply it with 100.\n\nFraction of analyte excreted unchanged in urine in the time interval 0 to 24 h (fe0-24) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-24 by the Dose and multiply it with 100.', 'unitOfMeasure': 'percent of analyte', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Apparent and Renal Clearance of the Analyte in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'CL/F after first dose', 'categories': [{'measurements': [{'value': '198', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '195', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '193', 'spread': '23.7', 'groupId': 'OG002'}, {'value': '159', 'spread': '19.4', 'groupId': 'OG003'}]}]}, {'title': 'CL/F at steady-state (N=9,8,9,8)', 'categories': [{'measurements': [{'value': '201', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '184', 'spread': '17.4', 'groupId': 'OG001'}, {'value': '189', 'spread': '21.5', 'groupId': 'OG002'}, {'value': '167', 'spread': '28.7', 'groupId': 'OG003'}]}]}, {'title': 'CLR (0-48h) after first dose', 'categories': [{'measurements': [{'value': '26.7', 'spread': '42.9', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '33.0', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '53.1', 'groupId': 'OG002'}, {'value': '13.9', 'spread': '44.1', 'groupId': 'OG003'}]}]}, {'title': 'CLR (0-24h) at steady-state (N=9,8,8,9)', 'categories': [{'measurements': [{'value': '29.7', 'spread': '52.0', 'groupId': 'OG000'}, {'value': '33.6', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '21.7', 'spread': '47.1', 'groupId': 'OG002'}, {'value': '22.2', 'spread': '83.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Apparent clearance of the analyte in plasma (CL/F) after first dose and at steady-state, Renal clearance of the analyte in plasma after extravascular administration (CLR) after first dose and at steady-state.\n\nApparent clearance after first dose is defined as the dose divided by AUC0-∞; apparent clearance at steady-state is defined as the dose divided by AUC0-tau at steady-state.\n\nRenal clearance CLR(0-t) is defined as Ae0-t divided by AUC0-t.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Peak Trough Fluctuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '323', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '294', 'spread': '28.4', 'groupId': 'OG001'}, {'value': '281', 'spread': '26.4', 'groupId': 'OG002'}, {'value': '265', 'spread': '31.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Peak trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state', 'unitOfMeasure': 'PTF(%) of Empagliflozin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Linearity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.983', 'spread': '8.42', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '2.39', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '11.4', 'groupId': 'OG002'}, {'value': '0.962', 'spread': '19.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'The linearity index is defined as AUC0-tau divided by AUC0-∞ both at steady state.', 'unitOfMeasure': 'Fraction', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratios', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Accumulation ratio based on Cmax', 'categories': [{'measurements': [{'value': '1.09', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '20.9', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '22.3', 'groupId': 'OG002'}, {'value': '0.972', 'spread': '36.8', 'groupId': 'OG003'}]}]}, {'title': 'Accumulated ratio based on AUC0-tau', 'categories': [{'measurements': [{'value': '1.16', 'spread': '8.39', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '6.17', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '11.9', 'groupId': 'OG002'}, {'value': '1.12', 'spread': '20.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Accumulation ratio based on Cmax (RA,Cmax) and Accumulated ratio based on AUC0-tau (RA,AUC) at steady-state.\n\nAccumulation ratio for the respective doses were calculated using below mentioned equations:\n\nRA,Cmax = Cmax,ss/Cmax\n\nRA,AUC= AUCtau,ss/AUCtau', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 8 in Urinary Glucose Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3254.43', 'spread': '8250.43', 'groupId': 'OG000'}, {'value': '34638.37', 'spread': '16226.22', 'groupId': 'OG001'}, {'value': '78709.87', 'spread': '53463.52', 'groupId': 'OG002'}, {'value': '74030.40', 'spread': '35378.01', 'groupId': 'OG003'}, {'value': '88040.32', 'spread': '20265.87', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37645.43', 'ciLowerLimit': '11021.57', 'ciUpperLimit': '64269.30', 'pValueComment': 'This was non-confirmatory testing.', 'groupDescription': 'The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '82898.20', 'ciLowerLimit': '55344.83', 'ciUpperLimit': '110451.6', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo is calculated.', 'groupDescription': 'The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '79982.89', 'ciLowerLimit': '53087.22', 'ciUpperLimit': '106878.6', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean Difference to placebo is calculated.', 'groupDescription': 'The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '91306.96', 'ciLowerLimit': '64685.41', 'ciUpperLimit': '117928.5', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean Difference to placebo was calculated', 'groupDescription': 'The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '-2-0 hours(h) before drug administration and 0-2, 2-4, 4-6, 6-8, 8-12,12-16 and 16-24 h after drug administration on day -2 and day 8', 'description': 'Change from baseline to day 8 in urinary glucose excretion. Baseline is defined as Day -2.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) analysis set (PDS) contains of all patients who received study medication and have evaluable pharmacodynamic parameter data.'}, {'type': 'SECONDARY', 'title': 'Mean Daily Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.85', 'spread': '21.39', 'groupId': 'OG000'}, {'value': '-27.03', 'spread': '24.59', 'groupId': 'OG001'}, {'value': '-34.04', 'spread': '19.43', 'groupId': 'OG002'}, {'value': '-25.89', 'spread': '18.00', 'groupId': 'OG003'}, {'value': '-30.96', 'spread': '25.03', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0449', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.456', 'ciLowerLimit': '-30.543', 'ciUpperLimit': '-0.369', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo was calculated.', 'groupDescription': 'The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '0.0042', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.467', 'ciLowerLimit': '-39.085', 'ciUpperLimit': '-7.848', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo was calculated.', 'groupDescription': 'The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '0.0521', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.956', 'ciLowerLimit': '-30.057', 'ciUpperLimit': '0.145', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo was calculated.', 'groupDescription': 'The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '0.1676', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.602', 'ciLowerLimit': '-25.848', 'ciUpperLimit': '4.644', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo was calculated', 'groupDescription': 'The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0:00, 2:00, 5:00, 7:00, 10:00, 12:00,13:30 and 24:00 hours(h) after drug administration on day -2 and -0.05, 2:30, 5:00, 7:00, 10:00, 12.00, 13:30 and 24:00 hours (h) after drug administration on day 8', 'description': 'Change from baseline to Day 8 in mean daily glucose. Baseline is defined as Day -2.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PDS'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.88', 'spread': '12.88', 'groupId': 'OG000'}, {'value': '-21.01', 'spread': '6.38', 'groupId': 'OG001'}, {'value': '-25.69', 'spread': '9.88', 'groupId': 'OG002'}, {'value': '-14.21', 'spread': '26.00', 'groupId': 'OG003'}, {'value': '-24.85', 'spread': '8.18', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2239', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.269', 'ciLowerLimit': '-19.162', 'ciUpperLimit': '4.624', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo was calculated.', 'groupDescription': 'The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '0.0421', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-12.844', 'ciLowerLimit': '-25.205', 'ciUpperLimit': '-0.484', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo was calculated', 'groupDescription': 'The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '0.6527', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.719', 'ciLowerLimit': '-14.842', 'ciUpperLimit': '9.403', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo was calculated.', 'groupDescription': 'The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}, {'pValue': '0.1318', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.998', 'ciLowerLimit': '-20.818', 'ciUpperLimit': '2.822', 'pValueComment': 'This was non-confirmatory testing.', 'estimateComment': 'Mean difference to placebo was calculated.', 'groupDescription': 'The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline value has been used a continuous covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '-0:30 (Pre dose samples)', 'description': 'Percentage change from baseline to Day 8 in fasting plasma glucose. Baseline is defined as Day -2.', 'unitOfMeasure': 'percentage of fasting plasma glucose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PDS'}, {'type': 'SECONDARY', 'title': 'Serum Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'AUEC0-5 (12,9,9,9,9) on day-2', 'categories': [{'measurements': [{'value': '134', 'spread': '52.5', 'groupId': 'OG000'}, {'value': '185', 'spread': '79.2', 'groupId': 'OG001'}, {'value': '175', 'spread': '70.7', 'groupId': 'OG002'}, {'value': '137', 'spread': '64.7', 'groupId': 'OG003'}, {'value': '119', 'spread': '35.9', 'groupId': 'OG004'}]}]}, {'title': 'AUEC0-12 (12,9,9,9,9) on day-2', 'categories': [{'measurements': [{'value': '300', 'spread': '111', 'groupId': 'OG000'}, {'value': '474', 'spread': '149', 'groupId': 'OG001'}, {'value': '471', 'spread': '143', 'groupId': 'OG002'}, {'value': '336', 'spread': '161', 'groupId': 'OG003'}, {'value': '282', 'spread': '41.6', 'groupId': 'OG004'}]}]}, {'title': 'AUEC0-5 (11,9,8,9,9) on day8', 'categories': [{'measurements': [{'value': '122', 'spread': '52.0', 'groupId': 'OG000'}, {'value': '174', 'spread': '80.9', 'groupId': 'OG001'}, {'value': '180', 'spread': '74.7', 'groupId': 'OG002'}, {'value': '117', 'spread': '103', 'groupId': 'OG003'}, {'value': '101', 'spread': '37.2', 'groupId': 'OG004'}]}]}, {'title': 'AUEC0-12 (11,9,7,9,8) on day8', 'categories': [{'measurements': [{'value': '288', 'spread': '97.1', 'groupId': 'OG000'}, {'value': '417', 'spread': '132', 'groupId': 'OG001'}, {'value': '387', 'spread': '154', 'groupId': 'OG002'}, {'value': '266', 'spread': '193', 'groupId': 'OG003'}, {'value': '275', 'spread': '72.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8', 'description': 'Serum insulin measured for on day -2 and day 8 for AUEC0-5 and AUEC0-12. AUEC0-5: The area under the effect concentration-time curve over the time interval 0 to 5.\n\nAUEC0-12: The area under the effect concentration-time curve over the time interval 0 to 12.', 'unitOfMeasure': 'µU*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PDS'}, {'type': 'SECONDARY', 'title': 'Serum Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily (qd) in the morning.'}, {'id': 'OG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'OG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'classes': [{'title': 'Emax,0-5 (12,9,9,9,9) on day-2', 'categories': [{'measurements': [{'value': '38.1', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '55.2', 'spread': '29.9', 'groupId': 'OG001'}, {'value': '51.2', 'spread': '23.4', 'groupId': 'OG002'}, {'value': '40.2', 'spread': '19.4', 'groupId': 'OG003'}, {'value': '35.2', 'spread': '15.5', 'groupId': 'OG004'}]}]}, {'title': 'Emax,0-12 (12,9,9,9,9) on day-2', 'categories': [{'measurements': [{'value': '45.4', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '68.5', 'spread': '25.3', 'groupId': 'OG001'}, {'value': '72.1', 'spread': '27.7', 'groupId': 'OG002'}, {'value': '48.7', 'spread': '30.9', 'groupId': 'OG003'}, {'value': '45.3', 'spread': '11.3', 'groupId': 'OG004'}]}]}, {'title': 'Emin,0-5 (12,9,9,9,9) on day-2', 'categories': [{'measurements': [{'value': '10.3', 'spread': '5.46', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '5.45', 'groupId': 'OG001'}, {'value': '13.7', 'spread': '4.62', 'groupId': 'OG002'}, {'value': '9.16', 'spread': '7.59', 'groupId': 'OG003'}, {'value': '7.86', 'spread': '2.18', 'groupId': 'OG004'}]}]}, {'title': 'Emin,0-12 (12,9,9,9,9) on day-2', 'categories': [{'measurements': [{'value': '9.98', 'spread': '4.86', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '5.45', 'groupId': 'OG001'}, {'value': '13.5', 'spread': '4.37', 'groupId': 'OG002'}, {'value': '9.16', 'spread': '7.59', 'groupId': 'OG003'}, {'value': '7.86', 'spread': '2.18', 'groupId': 'OG004'}]}]}, {'title': 'Emax,0-5 (11,9,8,9,9) on day8', 'categories': [{'measurements': [{'value': '35.6', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '56.0', 'spread': '32.1', 'groupId': 'OG001'}, {'value': '56.3', 'spread': '25.4', 'groupId': 'OG002'}, {'value': '36.2', 'spread': '37.3', 'groupId': 'OG003'}, {'value': '29.6', 'spread': '11.7', 'groupId': 'OG004'}]}]}, {'title': 'Emax,0-12 (11,9,8,9,9) on day8', 'categories': [{'measurements': [{'value': '42.6', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '70.2', 'spread': '26.1', 'groupId': 'OG001'}, {'value': '68.6', 'spread': '31.1', 'groupId': 'OG002'}, {'value': '44.4', 'spread': '35.5', 'groupId': 'OG003'}, {'value': '37.3', 'spread': '8.10', 'groupId': 'OG004'}]}]}, {'title': 'Emin,0-5 (11,9,8,9,9) on day8', 'categories': [{'measurements': [{'value': '7.55', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '8.63', 'spread': '3.39', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '5.60', 'groupId': 'OG002'}, {'value': '5.33', 'spread': '3.14', 'groupId': 'OG003'}, {'value': '3.96', 'spread': '2.79', 'groupId': 'OG004'}]}]}, {'title': 'Emin,0-12 (11,9,8,9,9) on day8', 'categories': [{'measurements': [{'value': '7.41', 'spread': '3.90', 'groupId': 'OG000'}, {'value': '8.53', 'spread': '3.46', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '5.60', 'groupId': 'OG002'}, {'value': '5.17', 'spread': '3.19', 'groupId': 'OG003'}, {'value': '3.96', 'spread': '2.79', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8', 'description': 'Serum insulin measured for on day -2 and day 8 for Emax0-5, Emax0-12, Emin0-5 and Emin0-12.\n\nEmax: Maximum effect (maximum measured concentration of glucose or insulin in plasma) \\& Emin: Minimum effect (minimum measured concentration of glucose or insulin in plasma)', 'unitOfMeasure': 'µU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PDS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily (qd) in the morning.'}, {'id': 'FG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'FG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'FG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.'}, {'id': 'FG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This Phase I trial was randomised, double-blind, and placebo-controlled within dose groups. It was to be performed in 48 female and male patients with type 2 diabetes in 4 sequential groups of 12 patients each. Within each dose group, 9 patients were to receive active drug and 3 were to receive placebo.', 'preAssignmentDetails': '14 days wash-out of previous antidiabetic therapy followed by 8 days of once daily dosing at each dose level.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients were treated with matching placebo as tablet once daily in the morning.'}, {'id': 'BG001', 'title': 'Empagliflozin 2.5 mg qd', 'description': 'Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.'}, {'id': 'BG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.'}, {'id': 'BG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.'}, {'id': 'BG004', 'title': 'Empagliflozin 100 mg qd', 'description': 'Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '53.9', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '10.7', 'groupId': 'BG002'}, {'value': '58.9', 'spread': '8.8', 'groupId': 'BG003'}, {'value': '60.3', 'spread': '5.6', 'groupId': 'BG004'}, {'value': '56.9', 'spread': '8.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-03', 'studyFirstSubmitDate': '2013-08-09', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2014-07-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-03', 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests', 'timeFrame': 'day 1 to day 21', 'description': 'Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).'}, {'measure': 'Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results', 'timeFrame': 'day 1 to day 21', 'description': 'Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results'}, {'measure': 'Micturition Frequency', 'timeFrame': 'Baseline and Day 9', 'description': 'Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.'}, {'measure': 'Assessment of Tolerability by Investigator', 'timeFrame': 'day 21', 'description': 'Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.'}], 'secondaryOutcomes': [{'measure': 'Concentration of the Analyte in Plasma', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Maximum concentration of the analyte in plasma (Cmax) after first dose, Maximum, minimum (Cmin) and average (Cavg) concentration of the analyte in plasma at steady-state, Concentration of analyte in plasma at 24 h after administration of the 8th dose (at steady-state) (C24,8)'}, {'measure': 'Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'AUC0-∞: from 0 extrapolated to infinity after first dose AUCtau,1: over a uniform dosing interval tau after first dose AUCtau,ss: over a uniform dosing interval tau at steady-state AUCs were computed using the linear up/log down algorithm. If an analyte concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was to be used. If the analyte concentration was smaller than the preceding concentration, the logarithmic method was to be used.'}, {'measure': 'Time to Maximum Concentration of the Analyte in Plasma', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Time from last dosing to maximum concentration of the analyte in plasma (tmax) after first dose and at steady-state'}, {'measure': 'Terminal Rate Constant in Plasma', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Terminal rate constant in plasma after first dose and at steady-state'}, {'measure': 'Half-life and Mean Residence Time of the Analyte in Plasma', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Terminal half life of the analyte in plasma (t1/2) and mean residence time of the analyte in the body after single oral administration (MRTpo) after first dose and at steady-state.'}, {'measure': 'Apparent Volume of Distribution During the Terminal Phase', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Apparent volume of distribution during the terminal phase (Vz/F) after first dose and at steady state. Apparent volume is defined as CL/F divided by the terminal rate constant in plasma (either after first dose or at steady-state).'}, {'measure': 'Amount of Analyte Eliminated in Urine', 'timeFrame': '0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9', 'description': 'Amount of analyte that is eliminated in urine after first dose and at steady state from the time interval 0 to 24 h (Ae0-24) and 0 to 48 h (Ae0-48)'}, {'measure': 'Fraction of Analyte Excreted Unchanged in Urine', 'timeFrame': '0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9', 'description': 'Fraction of analyte excreted unchanged in urine in the time interval 0 to 12 h (fe0-12) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-12 by the Dose and multiply it with 100.\n\nFraction of analyte excreted unchanged in urine in the time interval 0 to 24 h (fe0-24) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-24 by the Dose and multiply it with 100.'}, {'measure': 'Apparent and Renal Clearance of the Analyte in Plasma', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Apparent clearance of the analyte in plasma (CL/F) after first dose and at steady-state, Renal clearance of the analyte in plasma after extravascular administration (CLR) after first dose and at steady-state.\n\nApparent clearance after first dose is defined as the dose divided by AUC0-∞; apparent clearance at steady-state is defined as the dose divided by AUC0-tau at steady-state.\n\nRenal clearance CLR(0-t) is defined as Ae0-t divided by AUC0-t.'}, {'measure': 'Peak Trough Fluctuation', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Peak trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state'}, {'measure': 'Linearity Index', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'The linearity index is defined as AUC0-tau divided by AUC0-∞ both at steady state.'}, {'measure': 'Accumulation Ratios', 'timeFrame': '-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.', 'description': 'Accumulation ratio based on Cmax (RA,Cmax) and Accumulated ratio based on AUC0-tau (RA,AUC) at steady-state.\n\nAccumulation ratio for the respective doses were calculated using below mentioned equations:\n\nRA,Cmax = Cmax,ss/Cmax\n\nRA,AUC= AUCtau,ss/AUCtau'}, {'measure': 'Change From Baseline to Day 8 in Urinary Glucose Excretion', 'timeFrame': '-2-0 hours(h) before drug administration and 0-2, 2-4, 4-6, 6-8, 8-12,12-16 and 16-24 h after drug administration on day -2 and day 8', 'description': 'Change from baseline to day 8 in urinary glucose excretion. Baseline is defined as Day -2.'}, {'measure': 'Mean Daily Glucose', 'timeFrame': '0:00, 2:00, 5:00, 7:00, 10:00, 12:00,13:30 and 24:00 hours(h) after drug administration on day -2 and -0.05, 2:30, 5:00, 7:00, 10:00, 12.00, 13:30 and 24:00 hours (h) after drug administration on day 8', 'description': 'Change from baseline to Day 8 in mean daily glucose. Baseline is defined as Day -2.'}, {'measure': 'Fasting Plasma Glucose', 'timeFrame': '-0:30 (Pre dose samples)', 'description': 'Percentage change from baseline to Day 8 in fasting plasma glucose. Baseline is defined as Day -2.'}, {'measure': 'Serum Insulin', 'timeFrame': '0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8', 'description': 'Serum insulin measured for on day -2 and day 8 for AUEC0-5 and AUEC0-12. AUEC0-5: The area under the effect concentration-time curve over the time interval 0 to 5.\n\nAUEC0-12: The area under the effect concentration-time curve over the time interval 0 to 12.'}, {'measure': 'Serum Insulin', 'timeFrame': '0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8', 'description': 'Serum insulin measured for on day -2 and day 8 for Emax0-5, Emax0-12, Emin0-5 and Emin0-12.\n\nEmax: Maximum effect (maximum measured concentration of glucose or insulin in plasma) \\& Emin: Minimum effect (minimum measured concentration of glucose or insulin in plasma)'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.\n2. Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.\n3. Age \\>21 and Age \\<70 years (male and hysterectomised female patients) Age \\>60 and Age \\<70 years (postmenopausal female patients)\n4. Body Mass Index (BMI) \\>18.5 and \\<40 kg/m2\n5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation\n\nExclusion criteria:\n\n1. Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)\n2. Fasted blood glucose \\> 240 mg/dl (\\>13.3 mmol/L) on two consecutive days during washout.\n3. Glycosylated haemoglobin A1 (HbA1c) \\>8.5% at screening\n4. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:\n\n * Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)\n * Renal insufficiency (calculated creatinine clearance \\< 80 ml/min/1.73m²)\n * Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension \\> 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA (Transistoric ischaemic attack)\n * Neurological disorders (such as epilepsy) or psychiatric disorders\n * Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections)\n * Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder\n5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)\n6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\>450 ms)\n7. A history of additional risk factors for TdP (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)'}, 'identificationModule': {'nctId': 'NCT01924767', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Multiple Rising Oral Doses (2.5 mg to 100 mg) of BI 10773 Tablets in Male and Female Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': '1245.2'}, 'secondaryIdInfos': [{'id': '2007-000654-32', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 10773 (dose group 3)', 'description': 'multiple doses as tablet', 'interventionNames': ['Drug: BI 10773 Placebo', 'Drug: BI 10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 (dose group 4)', 'description': 'multiple doses as tablet', 'interventionNames': ['Drug: BI 10773', 'Drug: BI 10773 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 (dose group 1)', 'description': 'multiple doses as tablet', 'interventionNames': ['Drug: BI 10773 Placebo', 'Drug: BI 10773']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 (dose group 2)', 'description': 'multiple doses as tablet', 'interventionNames': ['Drug: BI 10773 Placebo', 'Drug: BI 10773']}], 'interventions': [{'name': 'BI 10773 Placebo', 'type': 'DRUG', 'description': 'po taken fasting with 240 mL water', 'armGroupLabels': ['BI 10773 (dose group 2)']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'po taken fasting with 240 mL water', 'armGroupLabels': ['BI 10773 (dose group 4)']}, {'name': 'BI 10773 Placebo', 'type': 'DRUG', 'description': 'po taken fasting with 240 mL water', 'armGroupLabels': ['BI 10773 (dose group 3)']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'po taken fasting with 240 mL water', 'armGroupLabels': ['BI 10773 (dose group 3)']}, {'name': 'BI 10773 Placebo', 'type': 'DRUG', 'description': 'po taken fasting with 240 mL water', 'armGroupLabels': ['BI 10773 (dose group 1)']}, {'name': 'BI 10773 Placebo', 'type': 'DRUG', 'description': 'po taken fasting with 240 mL water', 'armGroupLabels': ['BI 10773 (dose group 4)']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'po taken fasting with 240 mL water', 'armGroupLabels': ['BI 10773 (dose group 2)']}, {'name': 'BI 10773', 'type': 'DRUG', 'description': 'po taken fasting with 240 mL water', 'armGroupLabels': ['BI 10773 (dose group 1)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neuss', 'country': 'Germany', 'facility': '1245.2.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}