Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-28 @ 1:36 AM
Study NCT ID:
NCT00740051
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2008-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Sponsor:
Organization:
Raw JSON
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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}, 'limitationsAndCaveats': {'description': 'Primary analysis (at interim) was rerun using final study database'}}, 'adverseEventsModule': {'timeFrame': '52 weeks + 7 days', 'description': 'These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo/Glimepiride', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)', 'otherNumAtRisk': 76, 'otherNumAffected': 40, 'seriousNumAtRisk': 76, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)', 'otherNumAtRisk': 151, 'otherNumAffected': 59, 'seriousNumAtRisk': 151, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c Change From Baseline at Week 18 (Interim Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '-0.29', 'pValueComment': 'No adjustment of p-values', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Linagliptin versus 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 Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule.'}, {'type': 'PRIMARY', 'title': 'HbA1c Change From Baseline at Week 18 (Final Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.32', 'pValueComment': 'No adjustment of p-values', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Linagliptin versus Placebo. The primary analysis performed at the interim was re-run at the end of the study to accommodate changes made to the final study database.', '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 Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule.'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-20.5', 'ciLowerLimit': '-31.1', 'ciUpperLimit': '-9.9', 'pValueComment': 'No adjustment of p-values', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.4', 'groupDescription': 'Linagliptin versus 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 Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0374', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.576', 'ciLowerLimit': '1.057', 'ciUpperLimit': '6.279', 'pValueComment': 'No adjustment of p-values', 'groupDescription': 'Linagliptin versus Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 18', 'description': 'Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.', 'unitOfMeasure': 'percent of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) patients with baseline HbA1c \\>= 7.0%. Patients without a value at week 18 were analysed as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.285', 'ciLowerLimit': '0.710', 'ciUpperLimit': '15.196', 'pValueComment': 'No adjustment of p-values', 'groupDescription': 'Linagliptin vs. Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 18', 'description': 'Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.', 'unitOfMeasure': 'percent of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS patients with baseline HbA1c \\>= 6.5%. Patients without a value at Week 18 were analysed as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.801', 'ciLowerLimit': '1.374', 'ciUpperLimit': '5.711', 'pValueComment': 'No adjustment of p-values', 'groupDescription': 'Linagliptin versus Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 18', 'description': 'Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.', 'unitOfMeasure': 'percent of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders.'}, {'type': 'SECONDARY', 'title': 'The Change in HbA1c From Baseline by Visit Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Glimepiride', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'classes': [{'title': 'Change from baseline at week 6 (N=64, 136)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 12 (N=57, 129)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 18 (N=47, 118)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 22 (N=46, 113)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 26 (N=50, 110)', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 30 (N=49, 98)', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 34 (N=50, 96)', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 40 (N=49, 94)', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 46 (N=45, 92)', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 52 (N=45, 92)', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52', 'description': 'HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (OC)'}, {'type': 'SECONDARY', 'title': 'The Change in FPG From Baseline by Visit Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Glimepiride', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'OG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'classes': [{'title': 'Change from baseline at week 6 (N=63, 134)', 'categories': [{'measurements': [{'value': '9.7', 'spread': '30.7', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '41.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 12 (N=55,92)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '-14.3', 'spread': '37.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 18 (N=47, 115)', 'categories': [{'measurements': [{'value': '5.0', 'spread': '32.4', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '35.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 22 (N=46, 110)', 'categories': [{'measurements': [{'value': '-19.3', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '-14.0', 'spread': '41.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 26 (N=50, 108)', 'categories': [{'measurements': [{'value': '-22.6', 'spread': '33.8', 'groupId': 'OG000'}, {'value': '-17.0', 'spread': '37.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 30 (N=48, 95)', 'categories': [{'measurements': [{'value': '-31.4', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '39.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 34 (N=48, 95)', 'categories': [{'measurements': [{'value': '-25.6', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '-15.8', 'spread': '36.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 40 (N=47, 92)', 'categories': [{'measurements': [{'value': '-19.5', 'spread': '33.2', 'groupId': 'OG000'}, {'value': '-19.0', 'spread': '36.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 46 (N=47, 92)', 'categories': [{'measurements': [{'value': '-22.8', 'spread': '32.3', 'groupId': 'OG000'}, {'value': '-18.1', 'spread': '38.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at week 52 (N=43, 86)', 'categories': [{'measurements': [{'value': '-19.1', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '-14.0', 'spread': '37.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52', 'description': 'This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (OC)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Glimepiride', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'FG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Other reason (not specified)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/Glimepiride', 'description': 'Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)'}, {'id': 'BG001', 'title': 'Linagliptin', 'description': 'Patients treated with Linagliptin 5mg once daily (up to 52 weeks)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '10.6', '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': '43', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI) continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.19', 'spread': '4.97', 'groupId': 'BG000'}, {'value': '29.09', 'spread': '5.62', 'groupId': 'BG001'}, {'value': '29.46', 'spread': '5.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated hemoglobin (HbA1c) - Interim Analysis', 'classes': [{'categories': [{'measurements': [{'value': '8.06', 'spread': '0.89', 'groupId': 'BG000'}, {'value': '8.11', 'spread': '0.95', 'groupId': 'BG001'}, {'value': '8.09', 'spread': '0.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline HbA1c was determined for the Full Analysis Set with a total of 73 patients treated with Placebo and 147 patients treated with Linagliptin (220 in total).', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting blood plasma (FPG) glucose', 'classes': [{'categories': [{'measurements': [{'value': '180.5', 'spread': '44.7', 'groupId': 'BG000'}, {'value': '183.3', 'spread': '46.4', 'groupId': 'BG001'}, {'value': '182.4', 'spread': '45.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline fasting blood plasma glucose was determined for the Full Analysis Set with a total of 73 patients treated with Placebo and 147 patients treated with Linagliptin (220 in total).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Number of participants and other baseline values taken from interim analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2008-08-21', 'resultsFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2008-08-21', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-19', 'studyFirstPostDateStruct': {'date': '2008-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c Change From Baseline at Week 18 (Interim Analysis)', '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 Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.'}, {'measure': 'HbA1c Change From Baseline at Week 18 (Final Analysis)', '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 Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.'}], 'secondaryOutcomes': [{'measure': 'Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)', 'timeFrame': 'Baseline and week 18', 'description': 'This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).'}, {'measure': 'Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)', 'timeFrame': 'Week 18', 'description': 'Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.'}, {'measure': 'Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)', 'timeFrame': 'Week 18', 'description': 'Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.'}, {'measure': 'Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)', 'timeFrame': 'Week 18', 'description': 'Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.'}, {'measure': 'The Change in HbA1c From Baseline by Visit Over Time', 'timeFrame': 'Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52', 'description': 'HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.'}, {'measure': 'The Change in FPG From Baseline by Visit Over Time', 'timeFrame': 'Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52', 'description': 'This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22974280', 'type': 'DERIVED', 'citation': 'Barnett AH, Patel S, Harper R, Toorawa R, Thiemann S, von Eynatten M, Woerle HJ. Linagliptin monotherapy in type 2 diabetes patients for whom metformin is inappropriate: an 18-week randomized, double-blind, placebo-controlled phase III trial with a 34-week active-controlled extension. Diabetes Obes Metab. 2012 Dec;14(12):1145-54. doi: 10.1111/dom.12011. Epub 2012 Oct 1.'}, {'pmid': '22234149', 'type': 'DERIVED', 'citation': 'Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.'}], 'seeAlsoLinks': [{'url': 'http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.50_Literature.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). 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Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)', 'orgStudyIdInfo': {'id': '1218.50'}, 'secondaryIdInfos': [{'id': '2007-007485-38', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linagliptin', 'description': '52 week treatment', 'interventionNames': 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