Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-04-11 @ 8:56 PM
Study NCT ID:
NCT00601250
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2008-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}], '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'}]}}, '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 day of first dose until 7 days after last dose', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo', 'otherNumAtRisk': 177, 'otherNumAffected': 34, 'seriousNumAtRisk': 177, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg', 'otherNumAtRisk': 523, 'otherNumAffected': 54, 'seriousNumAtRisk': 523, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hepatitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Avulsion fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Snake bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '513', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'Linagliptin vs. Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], '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 percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.'}, {'type': 'SECONDARY', 'title': 'HbA1c Change From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '513', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.069', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '-0.363', 'spread': '0.027', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.431', 'ciLowerLimit': '-0.530', 'ciUpperLimit': '-0.333', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.050', 'groupDescription': 'Linagliptin vs. Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.'}, {'type': 'SECONDARY', 'title': 'HbA1c Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '513', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.096', 'spread': '0.056', 'groupId': 'OG000'}, {'value': '-0.499', 'spread': '0.034', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.596', 'ciLowerLimit': '-0.721', 'ciUpperLimit': '-0.471', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.064', 'groupDescription': 'Linagliptin vs. Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.'}, {'type': 'SECONDARY', 'title': 'HbA1c Change From Baseline at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '513', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.147', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-0.502', 'spread': '0.037', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.648', 'ciLowerLimit': '-0.785', 'ciUpperLimit': '-0.512', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.069', 'groupDescription': 'Linagliptin vs. Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. 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': '159', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '10.46', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-10.68', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-21.13', 'ciLowerLimit': '-27.3', 'ciUpperLimit': '-14.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.14', 'groupDescription': 'Linagliptin vs. Placebo', '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. 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': '159', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.58', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-11.94', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-16.52', 'ciLowerLimit': '-21.76', 'ciUpperLimit': '-11.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.67', 'groupDescription': 'Linagliptin vs. Placebo', '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': '159', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '3.86', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-12.86', 'spread': '1.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-16.73', 'ciLowerLimit': '-22.44', 'ciUpperLimit': '-11.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.91', 'groupDescription': 'Linagliptin vs. Placebo', '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': '159', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '10.32', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '-10.51', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-20.83', 'ciLowerLimit': '-26.81', 'ciUpperLimit': '-14.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.05', 'groupDescription': 'Linagliptin vs. Placebo', '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': '163', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '26.2', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.395', 'ciLowerLimit': '2.410', 'ciUpperLimit': '8.013', 'groupDescription': 'Linagliptin vs. Placebo\n\nThe odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 24', 'description': 'The percentage of patients with an HbA1c value below 7.0% 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 \\>= 7.0%. Only patients with baseline HbA1c \\>= 7%', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes the FAS 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': '175', 'groupId': 'OG000'}, {'value': '513', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '28.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 24', 'description': 'The percentage of patients with an HbA1c value below 7.0% 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 \\>= 7.0%.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes the Full Analysis Set (FAS). 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': '171', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '5.456', 'ciLowerLimit': '1.907', 'ciUpperLimit': '15.614', 'groupDescription': 'Linagliptin vs. Placebo\n\nThe odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', '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 \\>= 6.5%. Only patients with baseline HbA1c \\>= 6.5%', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes the FAS 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': '175', 'groupId': 'OG000'}, {'value': '513', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}]}]}], '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 \\>= 6.5%.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '513', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '49.7', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.754', 'ciLowerLimit': '2.486', 'ciUpperLimit': '5.669', 'groupDescription': 'Linagliptin vs. Placebo\n\nThe odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 24', 'description': 'The percentage of patients with an HbA1c reduction from baseline \\>= 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 Full Analysis Set (FAS) included all 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 Blood Glucose (PPG) Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '18.27', 'spread': '12.85', 'groupId': 'OG000'}, {'value': '-48.86', 'spread': '7.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-67.13', 'ciLowerLimit': '-94.69', 'ciUpperLimit': '-39.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.88', 'groupDescription': 'Linagliptin vs. Placebo', '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 PPG and previous anti-diabetic medication.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)'}, {'type': 'SECONDARY', 'title': '2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '10.90', 'spread': '9.23', 'groupId': 'OG000'}, {'value': '-30.90', 'spread': '5.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.80', 'ciLowerLimit': '-61.71', 'ciUpperLimit': '-21.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.02', 'groupDescription': 'Linagliptin vs. Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'FG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'number who started treatment', 'groupId': 'FG000', 'numSubjects': '177'}, {'comment': 'number who started treatment. One additional patient was randomised but not treated.', 'groupId': 'FG001', 'numSubjects': '523'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'number who completed treatment', 'groupId': 'FG000', 'numSubjects': '163'}, {'comment': 'number who completed treatment', 'groupId': 'FG001', 'numSubjects': '484'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Other incl. lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '523', 'groupId': 'BG001'}, {'value': '700', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'BG001', 'title': 'Linagliptin', 'description': 'Patients randomized to receive treatment with Linagliptin 5 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '56.5', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI) continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.05', 'spread': '5.01', 'groupId': 'BG000'}, {'value': '29.85', 'spread': '4.84', 'groupId': 'BG001'}, {'value': '29.90', 'spread': '4.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated haemoglobin A1 (HbA1C)', 'classes': [{'categories': [{'measurements': [{'value': '8.02', 'spread': '0.88', 'groupId': 'BG000'}, {'value': '8.09', 'spread': '0.86', 'groupId': 'BG001'}, {'value': '8.08', 'spread': '0.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting blood plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '166.42', 'spread': '41.89', 'groupId': 'BG000'}, {'value': '169.62', 'spread': '43.51', 'groupId': 'BG001'}, {'value': '168.81', 'spread': '43.10', 'groupId': 'BG002'}]}]}], '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': 701}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2008-01-15', 'resultsFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-13', 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', '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 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 7.0% 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 \\>= 7.0%. Only patients with baseline HbA1c \\>= 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 7.0% 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 \\>= 7.0%.'}, {'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 \\>= 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 \\>= 6.5%.'}, {'measure': 'Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'The percentage of patients with an HbA1c reduction from baseline \\>= 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 Blood 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 PPG and previous anti-diabetic medication.'}, {'measure': '2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '27484756', 'type': 'DERIVED', 'citation': 'Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug\n2. Diagnosis of type 2 diabetes prior to informed consent\n3. Glycosylated haemoglobin A1 (HbA1c)at screening:\n\n For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%\n4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in\n5. Age 18 -80 years\n6. BMI (Body Mass Index) less than 40 kg/m2\n7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation\n\nExclusion criteria:\n\n1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent\n2. Impaired hepatic function\n3. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo\n4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent\n5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent\n6. Treatment with insulin within 3 months prior to informed consent\n7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent\n8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse\n9. Participation in another trial with an investigational drug within 2 months prior to informed consent\n10. Pre-menopausal women who:\n\n * are nursing or pregnant,\n * or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.\n11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.\n12. Renal failure or renal impairment\n13. Unstable or acute congestive heart failure\n14. Acute or chronic metabolic acidosis (present in patient history)\n15. Hereditary galactose intolerance'}, 'identificationModule': {'nctId': 'NCT00601250', 'briefTitle': 'Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy', 'orgStudyIdInfo': {'id': '1218.17'}, 'secondaryIdInfos': [{'id': '2007-002457-24', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linagliptin', 'description': 'Patients receive linagliptin 5 mg tablets once daily', 'interventionNames': ['Drug: linagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive placebo tablets matching linagliptin 5 mg tablets once daily', 'interventionNames': ['Drug: linagliptin']}], 'interventions': [{'name': 'linagliptin', 'type': 'DRUG', 'description': 'Patients receive linagliptin 5 mg tablets once daily', 'armGroupLabels': ['Placebo']}, {'name': 'linagliptin', 'type': 'DRUG', 'description': 'Patients receive linagliptin 5 mg tablets once daily', 'armGroupLabels': ['Linagliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': '1218.17.10003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': '1218.17.10014 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': '1218.17.10001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Northglenn', 'state': 'Colorado', 'country': 'United States', 'facility': '1218.17.10021 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.88554, 'lon': -104.9872}}, {'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': '1218.17.10010 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': '1218.17.10011 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': '1218.17.10008 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 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