Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-29 @ 12:27 PM
Study NCT ID:
NCT00716092
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2008-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
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'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, '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, up to 35 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo', 'otherNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg', 'otherNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg', 'otherNumAtRisk': 41, 'otherNumAffected': 6, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weighted Mean Glucose (WMG) Change From Baseline at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'OG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-19.8', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '-26.1', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-19.9', 'ciLowerLimit': '-28.0', 'ciUpperLimit': '-11.9', 'pValueComment': 'There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) was to be considered descriptive.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.0', 'groupDescription': 'BI1356 minus Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for WMG. Sitagliptin results are from model containing all 3 groups'}, {'type': 'PRIMARY', 'title': 'GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'OG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '15.3', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '18.1', 'ciLowerLimit': '12.4', 'ciUpperLimit': '23.9', 'pValueComment': 'There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) will be considered descriptive.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.9', 'groupDescription': 'BI1356 minus Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.', 'unitOfMeasure': 'pmol*h/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. Analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one ontreatment value for GLP-1. Sitagliptin results are from model containing all 3 groups.'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose (FPG) Change From Baseline at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'OG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-10.9', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '-15.6', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0283', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-10.8', 'ciLowerLimit': '-20.4', 'ciUpperLimit': '-1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.8', 'groupDescription': 'BI1356 minus Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for FPG. Sitagliptin results are from model containing all 3 groups'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'OG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '-98.4', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '-119.1', 'spread': '13.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-106.5', 'ciLowerLimit': '-147.0', 'ciUpperLimit': '-66.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.3', 'groupDescription': 'BI1356 minus Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).', 'unitOfMeasure': 'mg*h/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic set (PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo, further restricted to patients who had a baseline and at least one on-treatment value for Glucose AUEC(0-3h). Sitagliptin results from model with all 3 groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'OG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-20.1', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '-26.1', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1274', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '13.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.9', 'groupDescription': 'BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for WMG.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'OG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '15.3', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3130', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '8.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7', 'groupDescription': 'BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.', 'unitOfMeasure': 'pmol*h/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for GLP-1.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'OG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'OG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-15.6', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2281', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '13.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.3', 'groupDescription': 'BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 FPG value minus the baseline FPG value. 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This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.', 'unitOfMeasure': 'mg*h/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for Plasma Glucose AUEC (0-3h).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'FG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'FG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other incl. Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients randomized to receive treatment with matching placebo'}, {'id': 'BG001', 'title': 'BI1356', 'description': 'Patients randomized to receive treatment with BI1356 5 mg'}, {'id': 'BG002', 'title': 'Sitagliptin', 'description': 'Patients randomized to receive treatment with Sitagliptin 100 mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '10.11', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '7.85', 'groupId': 'BG002'}, {'value': '61.1', 'spread': '9.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI) continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '3.83', 'groupId': 'BG000'}, {'value': '31.4', 'spread': '4.48', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '4.56', 'groupId': 'BG002'}, {'value': '30.8', 'spread': '4.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin A1 (HbA1C) continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.47', 'spread': '0.53', 'groupId': 'BG000'}, {'value': '7.32', 'spread': '0.59', 'groupId': 'BG001'}, {'value': '7.17', 'spread': '0.44', 'groupId': 'BG002'}, {'value': '7.32', 'spread': '0.53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG) continuous', 'classes': [{'categories': [{'measurements': [{'value': '172.8', 'spread': '28.81', 'groupId': 'BG000'}, {'value': '166.9', 'spread': '27.65', 'groupId': 'BG001'}, {'value': '160.3', 'spread': '25.35', 'groupId': 'BG002'}, {'value': '166.6', 'spread': '27.55', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-06-18', 'studyFirstSubmitDate': '2008-07-15', 'resultsFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2008-07-15', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-13', 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.'}, {'measure': 'Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.'}, {'measure': 'Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.'}, {'measure': 'Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.'}], 'primaryOutcomes': [{'measure': 'Weighted Mean Glucose (WMG) Change From Baseline at Day 28', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.'}, {'measure': 'GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.'}], 'secondaryOutcomes': [{'measure': 'Fasting Plasma Glucose (FPG) Change From Baseline at Day 28', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.'}, {'measure': 'Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28', 'timeFrame': 'Baseline and day 28', 'description': 'The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug\n* Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in\n\nExclusion criteria:\n\n* Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent\n* Impaired hepatic function\n* Renal insufficiency with a creatinine clearance \\< 50 mL/min\n* Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.'}, 'identificationModule': {'nctId': 'NCT00716092', 'briefTitle': 'The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A 4-week, Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group Study Comparing the Influence of BI 1356 (5 mg) and Sitagliptin (100 mg) Administered Orally Once Daily on Various Biomarkers in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': '1218.37'}, 'secondaryIdInfos': [{'id': '2007-007865-19', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin.', 'interventionNames': ['Drug: Placebo (linagliptin)', 'Drug: Placebo (sitagliptin)']}, {'type': 'EXPERIMENTAL', 'label': 'Linagliptin', 'description': 'Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin.', 'interventionNames': ['Drug: Placebo (sitagliptin)', 'Drug: Linagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': 'Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.', 'interventionNames': ['Drug: Placebo (linagliptin)', 'Drug: Sitagliptin']}], 'interventions': [{'name': 'Placebo (linagliptin)', 'type': 'DRUG', 'description': 'once daily for 28 days', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Placebo (linagliptin)', 'type': 'DRUG', 'description': 'once daily for 28 days', 'armGroupLabels': ['Placebo']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': '100 mg once daily for 28 days', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Placebo (sitagliptin)', 'type': 'DRUG', 'description': 'once daily for 28 days', 'armGroupLabels': ['Linagliptin']}, {'name': 'Placebo (sitagliptin)', 'type': 'DRUG', 'description': 'once daily for 28 days', 'armGroupLabels': ['Placebo']}, {'name': 'Linagliptin', 'type': 'DRUG', 'description': '5mg once daily for 28 days', 'armGroupLabels': ['Linagliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': '1218.37.49003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Mainz', 'country': 'Germany', 'facility': '1218.37.49002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Neuss', 'country': 'Germany', 'facility': '1218.37.49001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}