Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT00996658
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2009-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
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}, 'limitationsAndCaveats': {'description': 'During the conduct of this trial, pioglitazone was removed from the market in France due to safety issues, and this resulted in premature termination of a number of French patients.'}}, 'adverseEventsModule': {'timeFrame': 'From drug start up to drug stop (max 24 weeks)+ 7 days', 'description': 'For the analysis of AEs, all events with an onset after the first dose of trial medication up to a period of 7 days after the last dose of trial medication were assigned to the randomised treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet', 'otherNumAtRisk': 89, 'otherNumAffected': 16, 'seriousNumAtRisk': 89, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily', 'otherNumAtRisk': 183, 'otherNumAffected': 31, 'seriousNumAtRisk': 183, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Hepatitis E', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '-0.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline HbA1c and centre', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 24 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline HbA1c and centre', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '-0.28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline HbA1c and centre', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline HbA1c and centre', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 18 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'title': 'Responder (HbA1c < 7.0%)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder (HbA1c >= 7.0%)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.939', 'ciLowerLimit': '1.432', 'ciUpperLimit': '6.032', 'groupDescription': 'Linagliptin vs Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c \\>=7.0% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'title': 'Responder (HbA1c < 6.5%)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder (HbA1c >= 6.5%)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.902', 'ciLowerLimit': '1.440', 'ciUpperLimit': '10.572', 'groupDescription': 'Linagliptin vs Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c \\>=6.5% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'title': 'Responder (reduction in HbA1c >= 0.5%)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder (reduction in HbA1c < 0.5%)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.059', 'ciLowerLimit': '1.216', 'ciUpperLimit': '3.485', 'groupDescription': 'Linagliptin vs. Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication. Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0280', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-10.4', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '-1.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 24 weeks', 'description': 'Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24', 'unitOfMeasure': 'mg/dL (milligrams per deciliter)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-15.7', 'ciLowerLimit': '-24.5', 'ciUpperLimit': '-6.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6', 'unitOfMeasure': 'mg/dL (milligrams per deciliter)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-20.2', 'ciUpperLimit': '-1.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12', 'unitOfMeasure': 'mg/dL (milligrams per deciliter)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'OG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2137', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-16.0', 'ciUpperLimit': '3.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 18 weeks', 'description': 'Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18', 'unitOfMeasure': 'mg/dL (milligrams per deciliter)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Tablet', 'description': 'Placebo matching linagliptin 5 mg tablet'}, {'id': 'FG001', 'title': 'Linagliptin 5 mg Tablet', 'description': 'Linagliptin 5 mg (milligrams) tablet given by mouth once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Non-compliance issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Tablet'}, {'id': 'BG001', 'title': 'Linagliptin 5 mg Tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}]}, {'title': '65 to 74 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'spread': '19.8', 'groupId': 'BG000'}, {'value': '74.4', 'spread': '20.4', 'groupId': 'BG001'}, {'value': '74.4', 'spread': '20.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight categories', 'classes': [{'title': '<= 70 kilograms', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}, {'title': '> 70 to 80 kilograms', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': '> 80 to 90 kilograms', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': '> 90 kilograms', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '28.2', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '28.2', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI) categories', 'classes': [{'title': '< 25 kilograms/square meter', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': '>= 25 and < 30 kilograms/square meter', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': '>= 30 kilograms/square meter', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '162.0', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '161.4', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '161.6', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '97.7', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '98.1', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '98.0', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking status', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Currently smokes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol status', 'classes': [{'title': 'Non drinker', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}, {'title': 'Drinks - no interference with study', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Drinks - investigator opinion/interfere with study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Six participants (three participants per treatment) were excluded from all analyses due to serious site non-compliance. Thus, the total participants in Baseline Measures (272) is six less than total in Participant Flow (278).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2009-10-15', 'resultsFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-13', 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks', 'timeFrame': 'baseline, 24 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks', 'timeFrame': 'baseline, 6 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin'}, {'measure': 'Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin'}, {'measure': 'Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks', 'timeFrame': 'baseline, 18 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin'}, {'measure': 'Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks', 'timeFrame': '24 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin'}, {'measure': 'Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks', 'timeFrame': '24 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin'}, {'measure': 'Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks', 'timeFrame': '24 weeks', 'description': 'Glycosylated hemoglobin is reported as a percentage of the total hemoglobin'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks', 'timeFrame': 'baseline, 24 weeks', 'description': 'Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks', 'timeFrame': 'baseline, 6 weeks', 'description': 'Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks', 'timeFrame': 'baseline, 18 weeks', 'description': 'Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '24824197', 'type': 'DERIVED', 'citation': "Bajaj M, Gilman R, Patel S, Kempthorne-Rawson J, Lewis-D'Agostino D, Woerle HJ. Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. Diabet Med. 2014 Dec;31(12):1505-14. doi: 10.1111/dme.12495. Epub 2014 Jul 7."}]}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Diagnosis of diabetes mellitus prior to informed consent\n2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)\n3. Glycosylated haemoglobin A1 \\>= 7.5% and \\<= 10%\n4. Age between 18 and less than 80\n5. \\- Body Mass index less or equal to 45\n\nExclusion criteria:\n\n1. Uncontrolled hyperglycaemia during run in period\n2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent\n3. Impaired hepatic function\n4. Gastric by pass surgery\n5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent\n6. Treatment with anti-obesity drugs\n7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent\n8. Premenopausal women who are nursing or pregnant 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 during the trial'}, 'identificationModule': {'nctId': 'NCT00996658', 'briefTitle': 'Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone', 'orgStudyIdInfo': {'id': '1218.61'}, 'secondaryIdInfos': [{'id': '2009-013289-20', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 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