Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-01 @ 11:48 PM
Study NCT ID:
NCT00789035
Status:
COMPLETED
Last Update Posted:
2014-06-18
First Post:
2008-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
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'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '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': 'From first drug administration until 7 days after last intake of study medication, up to 121 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.', 'otherNumAtRisk': 82, 'otherNumAffected': 1, 'seriousNumAtRisk': 82, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.', 'otherNumAtRisk': 81, 'otherNumAffected': 3, 'seriousNumAtRisk': 81, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Empagliflozin 10 mg qd', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.', 'otherNumAtRisk': 81, 'otherNumAffected': 5, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Empagliflozin 25 mg qd', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.', 'otherNumAtRisk': 82, 'otherNumAffected': 1, 'seriousNumAtRisk': 82, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.', 'otherNumAtRisk': 80, 'otherNumAffected': 7, 'seriousNumAtRisk': 80, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Intestinal functional disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': '0.09', 'groupId': 'OG003'}, {'value': '-0.75', 'spread': '0.09', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '-0.29', 'pValueComment': 'No formal testing so adjustment for multiple comparisons was not necessary.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': 'Difference calculated as empa 5mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.35', 'pValueComment': 'No formal testing so adjustment for multiple comparisons was not necessary.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': 'Difference calculated as empa 10mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.50', 'pValueComment': 'No formal testing so adjustment for multiple comparisons was not necessary.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': 'Difference calculated as empa 25mg minus placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change of HbA1c from baseline after 12 weeks of treatment.\n\nNote, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consists of all randomised patients who were treated with at least 1 dose of study drug and had a baseline measurement of the primary endpoint. Modified last observation carried forward was used as the imputation method (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change of FPG From Baseline After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '-23.26', 'spread': '3.59', 'groupId': 'OG001'}, {'value': '-28.92', 'spread': '3.59', 'groupId': 'OG002'}, {'value': '-31.08', 'spread': '3.59', 'groupId': 'OG003'}, {'value': '-29.96', 'spread': '4.02', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.\n\nNote, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (LOCF)'}, {'type': 'SECONDARY', 'title': 'Change of HbA1c From Baseline Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '-0.39', 'spread': '0.06', 'groupId': 'OG003'}, {'value': '-0.26', 'spread': '0.07', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '-0.58', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.59', 'spread': '0.08', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '-0.66', 'spread': '0.08', 'groupId': 'OG003'}, {'value': '-0.78', 'spread': '0.08', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 4, 8 and 12', 'description': 'Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, classical last observation carried forward (CLOCF) was used as the imputation method.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '29.6', 'groupId': 'OG002'}, {'value': '45.1', 'groupId': 'OG003'}, {'value': '45.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (CLOCF)'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}, {'value': '59.3', 'groupId': 'OG002'}, {'value': '59.8', 'groupId': 'OG003'}, {'value': '71.3', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (CLOCF)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.95', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '-1.02', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '-0.90', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '-0.01', 'spread': '0.54', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Results for change of FPI from baseline at week 12 based on ANCOVA.', 'unitOfMeasure': 'mU/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (CLOCF)'}, {'type': 'SECONDARY', 'title': 'Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '-0.79', 'spread': '0.25', 'groupId': 'OG003'}, {'value': '-0.37', 'spread': '0.27', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.', 'unitOfMeasure': 'mU/L x mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (CLOCF)'}, {'type': 'SECONDARY', 'title': 'Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.20', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '2.54', 'groupId': 'OG002'}, {'value': '2.13', 'spread': '2.43', 'groupId': 'OG003'}, {'value': '6.69', 'spread': '2.58', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.', 'unitOfMeasure': 'mU / mmol', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (CLOCF)'}, {'type': 'SECONDARY', 'title': 'Change of Body Weight After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'OG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-2.33', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '-2.03', 'spread': '0.26', 'groupId': 'OG003'}, {'value': '-1.32', 'spread': '0.26', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Results for change of body weight after 12 weeks of treatment based on ANCOVA.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (CLOCF)'}, {'type': 'SECONDARY', 'title': 'Trough Concentrations of Empagliflozin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}], 'classes': [{'title': 'Day 28 (N=67, 75, 77)', 'categories': [{'measurements': [{'value': '31.6', 'spread': '158', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '169', 'groupId': 'OG001'}, {'value': '117', 'spread': '154', 'groupId': 'OG002'}]}]}, {'title': 'Day 56 (N=69, 73, 75)', 'categories': [{'measurements': [{'value': '20.3', 'spread': '128', 'groupId': 'OG000'}, {'value': '51.6', 'spread': '190', 'groupId': 'OG001'}, {'value': '127', 'spread': '140', 'groupId': 'OG002'}]}]}, {'title': 'Day 84 (N=70, 77, 75)', 'categories': [{'measurements': [{'value': '22.9', 'spread': '132', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '156', 'groupId': 'OG001'}, {'value': '118', 'spread': '179', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 28, 56 and 84', 'description': 'Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'FG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'FG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'FG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'FG004', 'title': 'Metformin OL', 'description': 'Patients were to take a open-label (OL) dose of 500 mg Metformin twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '81'}, {'groupId': 'FG003', 'numSubjects': '82'}, {'groupId': 'FG004', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '81'}, {'groupId': 'FG004', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '406', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.'}, {'id': 'BG001', 'title': 'Empagliflozin 5 mg', 'description': 'Patients receive 5 mg Empagliflozin in tablets once daily.'}, {'id': 'BG002', 'title': 'Empagliflozin 10 mg', 'description': 'Patients receive 10 mg Empagliflozin in tablets once daily.'}, {'id': 'BG003', 'title': 'Empagliflozin 25 mg', 'description': 'Patients receive 25 mg Empagliflozin in tablets once daily.'}, {'id': 'BG004', 'title': 'Metformin OL', 'description': 'Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '56.4', 'spread': '10.3', 'groupId': 'BG003'}, {'value': '57.0', 'spread': '8.9', 'groupId': 'BG004'}, {'value': '57.5', 'spread': '9.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The treated set (TS) consisting of all randomised patients who were treated with at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-16', 'studyFirstSubmitDate': '2008-10-13', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change of HbA1c from baseline after 12 weeks of treatment.\n\nNote, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.'}], 'secondaryOutcomes': [{'measure': 'Change of FPG From Baseline After 12 Weeks of Treatment', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.\n\nNote, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.'}, {'measure': 'Change of HbA1c From Baseline Over Time', 'timeFrame': 'Baseline and weeks 4, 8 and 12', 'description': 'Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.'}, {'measure': 'Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment', 'timeFrame': '12 weeks', 'description': 'Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).'}, {'measure': 'Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment', 'timeFrame': '12 weeks', 'description': 'Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).'}, {'measure': 'Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Results for change of FPI from baseline at week 12 based on ANCOVA.'}, {'measure': 'Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.'}, {'measure': 'Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.'}, {'measure': 'Change of Body Weight After 12 Weeks of Treatment', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Results for change of body weight after 12 weeks of treatment based on ANCOVA.'}, {'measure': 'Trough Concentrations of Empagliflozin in Plasma', 'timeFrame': 'Days 28, 56 and 84', 'description': 'Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '35472672', 'type': 'DERIVED', 'citation': 'Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.'}, {'pmid': '23940010', 'type': 'DERIVED', 'citation': 'Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients with a diagnosis of type 2 diabetes mellitus\n* either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening\n* HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c \\>7.0 to ≤10.0%\n* HbA1c \\>7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients\n* Age between 18 and 80 years\n* BMI less than 40 kg/m2\n* Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation\n\nExclusion Criteria:\n\n1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent\n2. Impaired hepatic function\n3. Renal insufficiency or impaired renal function\n4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation\n5. Chronic or clinically relevant acute infections\n6. Current or chronic urogenital tract infection determined by medical history\n7. History of clinically relevant allergy/hypersensitivity\n8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent\n9. Treatment with anti obesity drugs\n10. Current treatment with systemic steroids\n11. Alcohol abuse\n12. Treatment with an investigational drug within 2 months prior to informed consent\n13. known intolerance to metformin\n14. Dehydration\n15. Unstable or acute CHF\n16. Acute or chronic acidosis\n17. Hereditary galactose intolerance\n18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control'}, 'identificationModule': {'nctId': 'NCT00789035', 'briefTitle': '12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control', 'orgStudyIdInfo': {'id': '1245.9'}, 'secondaryIdInfos': [{'id': 'EudraCT No 2008-000640-14'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'BI 10773', 'type': 'DRUG'}, {'name': 'placebo', 'type': 'DRUG'}, {'name': 'metformin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Capital Federal', 'country': 'Argentina', 'facility': '1245.9.54001 Boehringer Ingelheim Investigational Site'}, {'city': 'Capital Federal', 'country': 'Argentina', 'facility': '1245.9.54002 Boehringer Ingelheim Investigational Site'}, {'city': 'Capital Federal', 'country': 'Argentina', 'facility': '1245.9.54007 Boehringer Ingelheim Investigational Site'}, {'city': 'Capital Federal', 'country': 'Argentina', 'facility': '1245.9.54008 Boehringer Ingelheim Investigational Site'}, {'city': 'Capital Federal', 'country': 'Argentina', 'facility': '1245.9.54009 Boehringer Ingelheim Investigational Site'}, {'city': 'Capital Federal', 'country': 'Argentina', 'facility': '1245.9.54010 Boehringer Ingelheim Investigational Site'}, {'city': 'Mar del Plata', 'country': 'Argentina', 'facility': '1245.9.54004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'city': 'Mendoza', 'country': 'Argentina', 'facility': '1245.9.54003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'city': 'Salta', 'country': 'Argentina', 'facility': '1245.9.54005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'city': 'Salta', 'country': 'Argentina', 'facility': '1245.9.54006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'city': 'Karlovac', 'country': 'Croatia', 'facility': '1245.9.38504 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.49167, 'lon': 15.55}}, {'city': 'Krapinske Toplice', 'country': 'Croatia', 'facility': '1245.9.38503 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.09333, 'lon': 15.84333}}, {'city': 'Osijek', 'country': 'Croatia', 'facility': '1245.9.38506 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}, {'city': 'Varaždin', 'country': 'Croatia', 'facility': '1245.9.38505 Boehringer Ingelheim Investigational 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