Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-31 @ 11:08 PM
Study NCT ID:
NCT01370005
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2011-06-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': 'From drug administration until last drug administration plus seven days, up to 171 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.', 'otherNumAtRisk': 272, 'otherNumAffected': 43, 'seriousNumAtRisk': 272, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.', 'otherNumAtRisk': 276, 'otherNumAffected': 42, 'seriousNumAtRisk': 276, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.', 'otherNumAtRisk': 276, 'otherNumAffected': 55, 'seriousNumAtRisk': 276, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 17}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'seriousEvents': [{'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Carotid artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Acute vestibular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Electrocardiogram T wave inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Traumatic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '0.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '-0.52', 'pValueComment': 'Hierarchical testing, no adjustment of p-values.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'estimateComment': 'Difference calculated as empa 10mg minus placebo', 'groupDescription': 'Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.55', 'pValueComment': 'Hierarchical testing, no adjustment of p-values', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'estimateComment': 'Difference calculated as empa 25mg minus placebo', 'groupDescription': 'Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in HbA1c after 12 weeks of treatment.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS), which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.'}, {'type': 'PRIMARY', 'title': 'Mean 24-hour Systolic Blood Pressure Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '8.25', 'groupId': 'OG000'}, {'value': '-2.99', 'spread': '8.86', 'groupId': 'OG001'}, {'value': '-3.59', 'spread': '9.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.44', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '-2.09', 'pValueComment': 'Hierarchical testing, no adjustment of p-values.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'estimateComment': 'Difference calculated as empa 10mg minus placebo', 'groupDescription': 'Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.16', 'ciLowerLimit': '-5.50', 'ciUpperLimit': '-2.83', 'pValueComment': 'Hierarchical testing, no adjustment of p-values.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.68', 'estimateComment': 'Difference calculated as empa 25mg minus placebo', 'groupDescription': 'Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline of mean 24-hour systolic blood pressure (SBP).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Mean 24-hour Diastolic Blood Pressure Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '5.06', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '4.96', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '4.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.36', 'ciLowerLimit': '-2.15', 'ciUpperLimit': '-0.56', 'pValueComment': 'Hierarchical testing, no adjustment of p-values.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'estimateComment': 'Difference calculated as empa 10mg minus placebo', 'groupDescription': 'Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.72', 'ciLowerLimit': '-2.51', 'ciUpperLimit': '-0.93', 'pValueComment': 'Hierarchical testing, no adjustment of p-values.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'estimateComment': 'Difference calculated as empa 25mg minus placebo', 'groupDescription': 'Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With HbA1c <7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.26', 'ciLowerLimit': '3.51', 'ciUpperLimit': '11.18', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.59', 'ciLowerLimit': '3.70', 'ciUpperLimit': '11.75', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Proportion of patients with HbA1c \\<7% after 12 weeks.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Patients in the full analysis set (FAS) and with baseline HbA1c \\>= 7%. Treatment assignment as randomised.\n\nNon-completers (missing data due to early discontinuation or values after start of rescue medication) considered 'failure' was used as the imputation rule."}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose (FPG) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.19', 'spread': '38.29', 'groupId': 'OG000'}, {'value': '-15.23', 'spread': '33.32', 'groupId': 'OG001'}, {'value': '-24.45', 'spread': '35.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.76', 'ciLowerLimit': '-28.91', 'ciUpperLimit': '-18.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.63', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.20', 'ciLowerLimit': '-35.32', 'ciUpperLimit': '-25.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.61', 'estimateComment': 'Difference calculated as empa 25mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in FPG after 12 weeks of treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Body Weight Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '-2.16', 'spread': '2.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.49', 'ciLowerLimit': '-1.85', 'ciUpperLimit': '-1.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.98', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '-1.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in body weight after 12 weeks of treatment.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '8.74', 'groupId': 'OG000'}, {'value': '-3.40', 'spread': '9.55', 'groupId': 'OG001'}, {'value': '-4.12', 'spread': '9.55', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.94', 'ciLowerLimit': '-5.37', 'ciUpperLimit': '-2.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, N of antihypertensive medications, baseline HbA1c and baseline daytime SBP', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.78', 'ciLowerLimit': '-6.20', 'ciUpperLimit': '-3.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.72', 'estimateComment': 'Difference calculated as empa 25mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime SBP', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in daytime mean SBP after 12 weeks of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '5.41', 'groupId': 'OG001'}, {'value': '-1.58', 'spread': '5.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.56', 'ciLowerLimit': '-2.42', 'ciUpperLimit': '-0.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.98', 'ciLowerLimit': '-2.84', 'ciUpperLimit': '-1.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': 'Difference calculated as empa 25mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in daytime mean DBP after 12 weeks of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '10.21', 'groupId': 'OG001'}, {'value': '-2.47', 'spread': '11.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.50', 'ciLowerLimit': '-4.09', 'ciUpperLimit': '-0.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.90', 'ciLowerLimit': '-4.48', 'ciUpperLimit': '-1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'estimateComment': 'Difference calculated as empa 25mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in nighttime mean SBP after 12 weeks of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '6.80', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '6.21', 'groupId': 'OG001'}, {'value': '-0.75', 'spread': '6.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0566', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-1.93', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP', 'testedNonInferiority': False}, {'pValue': '0.0208', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'estimateComment': 'Difference calculated as empa 25mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in nighttime mean DBP after 12 weeks of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'spread': '11.92', 'groupId': 'OG000'}, {'value': '-4.73', 'spread': '12.54', 'groupId': 'OG001'}, {'value': '-5.45', 'spread': '12.43', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.92', 'ciLowerLimit': '-5.86', 'ciUpperLimit': '-1.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.99', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.80', 'ciLowerLimit': '-6.73', 'ciUpperLimit': '-2.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.98', 'estimateComment': 'Difference calculated as empa 25mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.02', 'spread': '6.58', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '7.10', 'groupId': 'OG001'}, {'value': '-3.01', 'spread': '7.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.93', 'ciLowerLimit': '-3.01', 'ciUpperLimit': '-0.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'estimateComment': 'Difference calculated as empa 10mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.89', 'ciLowerLimit': '-2.97', 'ciUpperLimit': '-0.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'estimateComment': 'Difference calculated as empa 25mg minus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in trough mean seated DBP after 12 weeks of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.\n\nValues after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Reaching Blood Pressure <130/80 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.49', 'ciLowerLimit': '1.39', 'ciUpperLimit': '4.45', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '0.0088', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.20', 'ciLowerLimit': '1.22', 'ciUpperLimit': '3.96', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Proportion of patients reaching blood pressure \\<130/80 mmHg after 12 weeks of treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Patients in the FAS without blood pressure control at baseline. Blood pressure control is defined as DBP\\<80 mmHg and SBP \\<130 mmHg. Treatment assignment as randomised.\n\nNon-completers (missing data due to early disc, values after start of rescue medication or changes in antihyp. therapy) considered 'failure' was used as the imputation rule."}, {'type': 'SECONDARY', 'title': 'Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'title': 'Number fulfilled', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Number not fulfilled', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks', 'description': 'A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure \\> 3 mmHg from baseline and reduction of weight from baseline \\> 2%', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Patients in the full analysis set (FAS). Treatment assignment as randomised.\n\nNon-completers (missing data due to early discontinuation, values after start of rescue medication or changes in antihypertensive therapy) considered 'failure' was used as the imputation rule."}, {'type': 'SECONDARY', 'title': 'Orthostatic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline: Positive', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Negative', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Positive', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Negative', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set for patients with available measurements at baseline and week 12. Treatment assignment as first medication taken.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Confirmed Hypoglycaemic Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From drug administration until last drug administration plus seven days, up to 171 days', 'description': 'Number of participants with confirmed hypoglycaemic adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'FG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '276'}, {'groupId': 'FG002', 'numSubjects': '277'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '265'}, {'groupId': 'FG002', 'numSubjects': '266'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non compliant with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Patient refusal to continue,not due toAE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '823', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Empa 10mg', 'description': 'Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Empa 25mg', 'description': 'Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '60.2', 'spread': '9.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '328', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}, {'value': '495', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h SBP value. Treatment assignment as randomized'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 825}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-22', 'studyFirstSubmitDate': '2011-06-08', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Confirmed Hypoglycaemic Adverse Events', 'timeFrame': 'From drug administration until last drug administration plus seven days, up to 171 days', 'description': 'Number of participants with confirmed hypoglycaemic adverse events'}], 'primaryOutcomes': [{'measure': 'HbA1c Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in HbA1c after 12 weeks of treatment.'}, {'measure': 'Mean 24-hour Systolic Blood Pressure Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline of mean 24-hour systolic blood pressure (SBP).'}], 'secondaryOutcomes': [{'measure': 'Mean 24-hour Diastolic Blood Pressure Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.'}, {'measure': 'Proportion of Patients With HbA1c <7%', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Proportion of patients with HbA1c \\<7% after 12 weeks.'}, {'measure': 'Fasting Plasma Glucose (FPG) Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in FPG after 12 weeks of treatment.'}, {'measure': 'Body Weight Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in body weight after 12 weeks of treatment.'}, {'measure': 'Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in daytime mean SBP after 12 weeks of treatment.'}, {'measure': 'Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in daytime mean DBP after 12 weeks of treatment.'}, {'measure': 'Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in nighttime mean SBP after 12 weeks of treatment.'}, {'measure': 'Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in nighttime mean DBP after 12 weeks of treatment.'}, {'measure': 'Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.'}, {'measure': 'Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in trough mean seated DBP after 12 weeks of treatment.'}, {'measure': 'Proportion of Patients Reaching Blood Pressure <130/80 mmHg', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Proportion of patients reaching blood pressure \\<130/80 mmHg after 12 weeks of treatment'}, {'measure': 'Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight', 'timeFrame': 'Baseline and 12 weeks', 'description': 'A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure \\> 3 mmHg from baseline and reduction of weight from baseline \\> 2%'}, {'measure': 'Orthostatic Blood Pressure', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '38770818', 'type': 'DERIVED', 'citation': 'Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.'}, {'pmid': '35472672', 'type': 'DERIVED', 'citation': 'Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.'}, {'pmid': '27977392', 'type': 'DERIVED', 'citation': 'Mancia G, Cannon CP, Tikkanen I, Zeller C, Ley L, Woerle HJ, Broedl UC, Johansen OE. Impact of Empagliflozin on Blood Pressure in Patients With Type 2 Diabetes Mellitus and Hypertension by Background Antihypertensive Medication. Hypertension. 2016 Dec;68(6):1355-1364. doi: 10.1161/HYPERTENSIONAHA.116.07703. Epub 2016 Oct 10.'}, {'pmid': '25271206', 'type': 'DERIVED', 'citation': 'Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ; EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015 Mar;38(3):420-8. doi: 10.2337/dc14-1096. Epub 2014 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients \\>=18 years with type 2 diabetes\n2. HbA1c of \\>= 7.0% (53 mmol/mol) and =\\< 10% (86 mmol/mol)\n3. Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg\n\nExclusion criteria:\n\n1. Uncontrolled hyperglycaemia with a glucose level \\>240 mg/dl (\\>13.3 mmol/L) after an overnight fast before randomization\n2. Known or suspected secondary hypertension\n3. 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