Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-26 @ 4:55 AM
Study NCT ID:
NCT00798161
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2008-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'South Africa']}, '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': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'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': 'Day of first dose until day of last dose plus 7 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo', 'otherNumAtRisk': 72, 'otherNumAffected': 20, 'seriousNumAtRisk': 72, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'M500 BID', 'description': 'Patients treated with Metformin 500 mg BID', 'otherNumAtRisk': 144, 'otherNumAffected': 27, 'seriousNumAtRisk': 144, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'M1000 BID', 'description': 'Patients treated with Metformin 1000 mg bis in die (BID)', 'otherNumAtRisk': 147, 'otherNumAffected': 27, 'seriousNumAtRisk': 147, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Lina 5', 'description': 'Patients treated with Linagliptin 5 mg once daily (OD)', 'otherNumAtRisk': 142, 'otherNumAffected': 31, 'seriousNumAtRisk': 142, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'L2.5+M500 BID', 'description': 'Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID)', 'otherNumAtRisk': 143, 'otherNumAffected': 31, 'seriousNumAtRisk': 143, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'L2.5 + M1000 BID', 'description': 'Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)', 'otherNumAtRisk': 143, 'otherNumAffected': 36, 'seriousNumAtRisk': 143, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'OL: L2.5+M1000 BID', 'description': 'Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)', 'otherNumAtRisk': 66, 'otherNumAffected': 18, 'seriousNumAtRisk': 66, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG003', 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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{'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg 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Last observation carried forward (LOCF) was used as the imputation rule.'}, {'type': 'SECONDARY', 'title': 'FPG Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}, {'value': '136', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '-15.8', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '-32.2', 'spread': '3.6', 'groupId': 'OG002'}, {'value': '-8.6', 'spread': '3.6', 'groupId': 'OG003'}, {'value': '-33.2', 'spread': '3.5', 'groupId': 'OG004'}, {'value': '-49.4', 'spread': '3.5', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-17.4', 'ciLowerLimit': '-27.2', 'ciUpperLimit': '-7.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.0', 'groupDescription': 'Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-17.2', 'ciLowerLimit': '-27.1', 'ciUpperLimit': '-7.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.0', 'groupDescription': 'Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-24.6', 'ciLowerLimit': '-34.4', 'ciUpperLimit': '-14.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.0', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-40.8', 'ciLowerLimit': '-50.6', 'ciUpperLimit': '-31.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.0', 'groupDescription': 'Linagliptin 5mg vs. linagliptin 2.5mg with metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'This change from baseline reflects the Week 24 FPG minus the baseline FPG. 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Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.'}, {'type': 'SECONDARY', 'title': 'FPG Change From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}, {'value': '136', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-20.8', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '-31.6', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '-10.8', 'spread': '3.2', 'groupId': 'OG003'}, {'value': '-38.7', 'spread': '3.2', 'groupId': 'OG004'}, {'value': '-48.3', 'spread': '3.2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-17.9', 'ciLowerLimit': '-26.7', 'ciUpperLimit': '-9.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.5', 'groupDescription': 'Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-16.8', 'ciLowerLimit': '-25.6', 'ciUpperLimit': '-7.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.5', 'groupDescription': 'Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-27.9', 'ciLowerLimit': '-36.7', 'ciUpperLimit': '-19.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.5', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-37.6', 'ciLowerLimit': '-46.4', 'ciUpperLimit': '-28.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.5', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 6', 'description': 'This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.'}, {'type': 'SECONDARY', 'title': 'FPG Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}, {'value': '136', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-21.8', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '-31.9', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '-8.4', 'spread': '3.4', 'groupId': 'OG003'}, {'value': '-36.2', 'spread': '3.4', 'groupId': 'OG004'}, {'value': '-49.9', 'spread': '3.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0024', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-14.4', 'ciLowerLimit': '-23.7', 'ciUpperLimit': '-5.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.7', 'groupDescription': 'Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-18.0', 'ciLowerLimit': '-27.4', 'ciUpperLimit': '-8.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.8', 'groupDescription': 'Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-27.8', 'ciLowerLimit': '-37.1', 'ciUpperLimit': '-18.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.7', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-41.5', 'ciLowerLimit': '-50.8', 'ciUpperLimit': '-32.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.7', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.'}, {'type': 'SECONDARY', 'title': 'FPG Change From Baseline at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}, {'value': '136', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-13.7', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '-30.3', 'spread': '3.5', 'groupId': 'OG002'}, {'value': '-9.2', 'spread': '3.4', 'groupId': 'OG003'}, {'value': '-34.6', 'spread': '3.4', 'groupId': 'OG004'}, {'value': '-48.1', 'spread': '3.4', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-20.9', 'ciLowerLimit': '-30.4', 'ciUpperLimit': '-11.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.8', 'groupDescription': 'Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-17.9', 'ciLowerLimit': '-27.4', 'ciUpperLimit': '-8.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.9', 'groupDescription': 'Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-25.4', 'ciLowerLimit': '-35.0', 'ciUpperLimit': '-15.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.9', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-39.0', 'ciLowerLimit': '-48.5', 'ciUpperLimit': '-29.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.9', 'groupDescription': 'Linagliptin 5 mg vs. Linagliptin 2.5 mg with Metformin 1000 mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 18', 'description': 'This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c <7.0% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}, {'value': '138', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '0', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '0', 'groupId': 'OG001'}, {'value': '30.7', 'spread': '0', 'groupId': 'OG002'}, {'value': '10.4', 'spread': '0', 'groupId': 'OG003'}, {'value': '30.1', 'spread': '0', 'groupId': 'OG004'}, {'value': '53.6', 'spread': '0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0062', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.372', 'ciLowerLimit': '1.278', 'ciUpperLimit': '4.402', 'groupDescription': 'Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.163', 'ciLowerLimit': '2.343', 'ciUpperLimit': '7.397', 'groupDescription': 'Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.854', 'ciLowerLimit': '2.363', 'ciUpperLimit': '9.973', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '17.094', 'ciLowerLimit': '8.238', 'ciUpperLimit': '35.471', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS treated and randomised patients with baseline HbA1c \\>= 7.0%. Non-completers were considered as failure imputation (NCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c<7.0 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}, {'value': '31.2', 'groupId': 'OG002'}, {'value': '10.4', 'groupId': 'OG003'}, {'value': '30.7', 'groupId': 'OG004'}, {'value': '54.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c <6.5% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '0', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '0', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '0', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '0', 'groupId': 'OG003'}, {'value': '13.1', 'spread': '0', 'groupId': 'OG004'}, {'value': '27.1', 'spread': '0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0102', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.465', 'ciLowerLimit': '1.342', 'ciUpperLimit': '8.943', 'groupDescription': 'Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.521', 'ciLowerLimit': '1.747', 'ciUpperLimit': '7.094', 'groupDescription': 'Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '0.0053', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.521', 'ciLowerLimit': '1.564', 'ciUpperLimit': '13.069', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '11.947', 'ciLowerLimit': '4.314', 'ciUpperLimit': '33.080', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =\\< 6.5%', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS treated and randomised patients with baseline HbA1c \\>= 6.5%. Non-completers were considered as failure imputation (NCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c < 6.5% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '12.3', 'groupId': 'OG002'}, {'value': '3.7', 'groupId': 'OG003'}, {'value': '13.1', 'groupId': 'OG004'}, {'value': '27.1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c Lowering by 0.5% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '0', 'groupId': 'OG000'}, {'value': '46.1', 'spread': '0', 'groupId': 'OG001'}, {'value': '65.9', 'spread': '0', 'groupId': 'OG002'}, {'value': '42.2', 'spread': '0', 'groupId': 'OG003'}, {'value': '71.5', 'spread': '0', 'groupId': 'OG004'}, {'value': '81.4', 'spread': '0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.181', 'ciLowerLimit': '1.903', 'ciUpperLimit': '5.316', 'groupDescription': 'Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '0.0027', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.382', 'ciLowerLimit': '1.352', 'ciUpperLimit': '4.196', 'groupDescription': 'Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.622', 'ciLowerLimit': '2.153', 'ciUpperLimit': '6.093', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '6.529', 'ciLowerLimit': '3.724', 'ciUpperLimit': '11.445', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 24', 'description': 'The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).'}, {'type': 'SECONDARY', 'title': 'Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.4', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '-82.9', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '-87.2', 'spread': '14.8', 'groupId': 'OG002'}, {'value': '-35.3', 'spread': '16.1', 'groupId': 'OG003'}, {'value': '-86.0', 'spread': '17.5', 'groupId': 'OG004'}, {'value': '-109.2', 'spread': '16.2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.8893', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-48.5', 'ciUpperLimit': '42.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.7', 'groupDescription': 'Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3234', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-22.0', 'ciLowerLimit': '-66.2', 'ciUpperLimit': '22.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.1', 'groupDescription': 'Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0373', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-50.8', 'ciLowerLimit': '-98.5', 'ciUpperLimit': '-3.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '23.8', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0018', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-73.9', 'ciLowerLimit': '-119.3', 'ciUpperLimit': '-28.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.7', 'groupDescription': 'Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Meal tolerance test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)'}, {'type': 'SECONDARY', 'title': 'HbA1c Change From Baseline at Week 24 for Open-label Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL: L2.5+M1000BID', 'description': 'Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.19', 'spread': '2.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with an on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.'}, {'type': 'SECONDARY', 'title': 'FPG Change From Baseline at Week 24 for Open-label Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL: L2.5+M1000BID', 'description': 'Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '-73.58', 'spread': '70.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with a baseline on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.'}, {'type': 'SECONDARY', 'title': 'Use of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'OG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'OG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'OG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'OG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'OG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '13.5', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}, {'value': '11.1', 'groupId': 'OG003'}, {'value': '7.3', 'groupId': 'OG004'}, {'value': '4.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0445', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.326', 'ciLowerLimit': '0.109', 'ciUpperLimit': '0.973', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0151', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.274', 'ciLowerLimit': '0.096', 'ciUpperLimit': '0.779', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0490', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.420', 'ciLowerLimit': '0.177', 'ciUpperLimit': '0.996', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2617', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.598', 'ciLowerLimit': '0.244', 'ciUpperLimit': '1.467', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': "The use of rescue therapy (SUs, thiazolidinediones \\[TZDs\\], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of patients requiring rescue therapy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'FG001', 'title': 'M500 Twice Daily (BID)', 'description': 'Patients treated with Metformin 500 mg BID'}, {'id': 'FG002', 'title': 'M1000 BID', 'description': 'Patients treated with Metformin 1000 mg BID'}, {'id': 'FG003', 'title': 'Lina 5', 'description': 'Patients treated with Linagliptin 5 mg once daily (OD)'}, {'id': 'FG004', 'title': 'L2.5+M500 BID', 'description': 'Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID'}, {'id': 'FG005', 'title': 'L2.5 + M1000 BID', 'description': 'Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID'}, {'id': 'FG006', 'title': 'OL: L2.5+M1000 BID', 'description': 'Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '147'}, {'groupId': 'FG003', 'numSubjects': '142'}, {'groupId': 'FG004', 'numSubjects': '143'}, {'groupId': 'FG005', 'numSubjects': '143'}, {'groupId': 'FG006', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '126'}, {'groupId': 'FG003', 'numSubjects': '121'}, {'groupId': 'FG004', 'numSubjects': '127'}, {'groupId': 'FG005', 'numSubjects': '132'}, {'groupId': 'FG006', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Other reason (incl. lack of efficacy)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}, {'value': '143', 'groupId': 'BG005'}, {'value': '66', 'groupId': 'BG006'}, {'value': '857', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo'}, {'id': 'BG001', 'title': 'M500BID', 'description': 'Patients treated with Metformin 500mg BID'}, {'id': 'BG002', 'title': 'M1000BID', 'description': 'Patients treated with Metformin 1000mg BID'}, {'id': 'BG003', 'title': 'Lina5', 'description': 'Patients treated with Linagliptin 5mg OD'}, {'id': 'BG004', 'title': 'L2.5+M500BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID'}, {'id': 'BG005', 'title': 'L2.5+M1000BID', 'description': 'Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID'}, {'id': 'BG006', 'title': 'L2.5+M1000BID (Open Label)', 'description': 'Open label set: Linagliptin 2.5mg + Metformin 1000mg BID'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '52.9', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '55.2', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '56.2', 'spread': '10.8', 'groupId': 'BG003'}, {'value': '55.6', 'spread': '11.2', 'groupId': 'BG004'}, {'value': '56.4', 'spread': '10.7', 'groupId': 'BG005'}, {'value': '53.5', 'spread': '11.1', 'groupId': 'BG006'}, {'value': '55.2', 'spread': '10.8', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '66', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}, {'value': '405', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '452', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI) continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.62', 'spread': '5.17', 'groupId': 'BG000'}, {'value': '28.92', 'spread': '4.83', 'groupId': 'BG001'}, {'value': '29.52', 'spread': '5.31', 'groupId': 'BG002'}, {'value': '28.95', 'spread': '4.67', 'groupId': 'BG003'}, {'value': '29.66', 'spread': '5.31', 'groupId': 'BG004'}, {'value': '28.55', 'spread': '4.80', 'groupId': 'BG005'}, {'value': '28.81', 'spread': '4.93', 'groupId': 'BG006'}, {'value': '29.07', 'spread': '4.97', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin A1 (HbA1C)', 'classes': [{'categories': [{'measurements': [{'value': '8.67', 'spread': '0.95', 'groupId': 'BG000'}, {'value': '8.66', 'spread': '0.90', 'groupId': 'BG001'}, {'value': '8.52', 'spread': '0.87', 'groupId': 'BG002'}, {'value': '8.70', 'spread': '0.97', 'groupId': 'BG003'}, {'value': '8.71', 'spread': '0.95', 'groupId': 'BG004'}, {'value': '8.68', 'spread': '1.03', 'groupId': 'BG005'}, {'value': '11.84', 'spread': '1.42', 'groupId': 'BG006'}, {'value': '8.91', 'spread': '1.31', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '203.7', 'spread': '51.2', 'groupId': 'BG000'}, {'value': '191.2', 'spread': '46.9', 'groupId': 'BG001'}, {'value': '192.3', 'spread': '52.8', 'groupId': 'BG002'}, {'value': '195.3', 'spread': '50.2', 'groupId': 'BG003'}, {'value': '198.6', 'spread': '60.2', 'groupId': 'BG004'}, {'value': '196.9', 'spread': '51.2', 'groupId': 'BG005'}, {'value': '261.8', 'spread': '80.9', 'groupId': 'BG006'}, {'value': '200.2', 'spread': '57.3', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 857}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2008-11-24', 'resultsFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-11', 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c Change From Baseline at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.'}], 'secondaryOutcomes': [{'measure': 'HbA1c Change From Baseline at Week 6', 'timeFrame': 'Baseline and week 6', 'description': 'HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.'}, {'measure': 'HbA1c Change From Baseline at Week 12', 'timeFrame': 'Baseline and week 12', 'description': 'HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.'}, {'measure': 'HbA1c Change From Baseline at Week 18', 'timeFrame': 'Baseline and week 18', 'description': 'HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.'}, {'measure': 'FPG Change From Baseline at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.'}, {'measure': 'FPG Change From Baseline at Week 2', 'timeFrame': 'Baseline and week 2', 'description': 'This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.'}, {'measure': 'FPG Change From Baseline at Week 6', 'timeFrame': 'Baseline and week 6', 'description': 'This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.'}, {'measure': 'FPG Change From Baseline at Week 12', 'timeFrame': 'Baseline and week 12', 'description': 'This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.'}, {'measure': 'FPG Change From Baseline at Week 18', 'timeFrame': 'Baseline and week 18', 'description': 'This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.'}, {'measure': 'Percentage of Patients With HbA1c <7.0% at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.'}, {'measure': 'Percentage of Patients With HbA1c<7.0 at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.'}, {'measure': 'Percentage of Patients With HbA1c <6.5% at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =\\< 6.5%'}, {'measure': 'Percentage of Patients With HbA1c < 6.5% at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%'}, {'measure': 'Percentage of Patients With HbA1c Lowering by 0.5% at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.'}, {'measure': 'Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.'}, {'measure': 'HbA1c Change From Baseline at Week 24 for Open-label Patients', 'timeFrame': 'Baseline and week 24', 'description': 'HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.'}, {'measure': 'FPG Change From Baseline at Week 24 for Open-label Patients', 'timeFrame': 'Baseline and week 24', 'description': 'This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.'}, {'measure': 'Use of Rescue Therapy', 'timeFrame': '24 weeks', 'description': "The use of rescue therapy (SUs, thiazolidinediones \\[TZDs\\], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast."}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '32328953', 'type': 'DERIVED', 'citation': 'Lv Q, Shen J, Miao L, Ye B, Schepers C, Plat A, Shi Y. Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c </= 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials. Diabetes Ther. 2020 Jun;11(6):1317-1330. doi: 10.1007/s13300-020-00819-9. Epub 2020 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm\n\nExclusion criteria:\n\nMyocardial infarction, stroke or transient ischemic attack (TIA), unstable or acute congestive heart failure, impaired hepatic function, treatment with rosiglitazone or pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with systemic steroids, renal failure or impairment, gastric bypass'}, 'identificationModule': {'nctId': 'NCT00798161', 'briefTitle': 'Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control', 'orgStudyIdInfo': {'id': '1218.46'}, 'secondaryIdInfos': [{'id': '2008-001640-40', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 1356 + metformin', 'description': 'BI 1356 low dose + metformin 500 mg, twice daily', 'interventionNames': ['Drug: BI 1356 + metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'matching placebo', 'description': 'matching placebo', 'interventionNames': ['Drug: matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BI 1356+ Metformin', 'description': 'BI 1356 low dose + metformin 1000 mg, twice daily', 'interventionNames': ['Drug: Bi 1356 + metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Metformin 500 mg, twice daily', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metformin', 'description': 'Metformin 1000 mg, twice daily', 'interventionNames': ['Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': 'BI 1356', 'description': 'BI 1356 high dose, once daily', 'interventionNames': ['Drug: BI 1356']}], 'interventions': [{'name': 'BI 1356', 'type': 'DRUG', 'description': 'BI 1356 high dose tablet, once daily', 'armGroupLabels': ['BI 1356']}, {'name': 'BI 1356 + metformin', 'type': 'DRUG', 'description': 'BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily', 'armGroupLabels': ['BI 1356 + metformin']}, {'name': 'Bi 1356 + metformin', 'type': 'DRUG', 'description': 'BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily', 'armGroupLabels': ['BI 1356+ Metformin']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin 500 mg tablet, twice daily', 'armGroupLabels': ['Metformin']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'metformin 1000 mg tablet, twice daily', 'armGroupLabels': ['metformin']}, {'name': 'matching placebo', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': '1218.46.11005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 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