Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT01383356
Status:
COMPLETED
Last Update Posted:
2014-03-28
First Post:
2011-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Period 1 (36 hours)+ Washout (35 days) +Period 2 (36 hours)', 'eventGroups': [{'id': 'EG000', 'title': 'Lina/Met 2.5mg/500mg', 'description': 'Combination tablet', 'otherNumAtRisk': 52, 'otherNumAffected': 17, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lina 2.5mg Plus Met 500mg', 'description': 'Single tablets', 'otherNumAtRisk': 50, 'otherNumAffected': 21, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lina/Met 2.5mg/500mg', 'description': 'Combination tablet'}, {'id': 'OG001', 'title': 'Lina 2.5mg Plus Met 500mg', 'description': 'Single tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '901.82', 'spread': '262.45', 'groupId': 'OG000'}, {'value': '770.52', 'spread': '189.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (GMR) in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '118', 'ciLowerLimit': '111', 'ciUpperLimit': '125', 'estimateComment': 'Lina/Met 2.5mg/500mg versus (vs.) Lina 2.5mg plus Met 500mg.', 'groupDescription': 'The two formulations are shown to be bioequivalent if the geometric mean ratio is contained within the 80 to 125 percent range both on measured data (statistical analysis 1) and on potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR, potency corrected (percent)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '122', 'ciLowerLimit': '114', 'ciUpperLimit': '130', 'estimateComment': 'Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.', 'groupDescription': 'ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of drug potency (DP) of Met in single tablet and DP of Met in combination tablet).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period', 'description': 'Maximum measured concentration of metformin in plasma, per period.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve 0 to Last Measurable Value (AUC0-t)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lina/Met 2.5mg/500mg', 'description': 'Combination tablet'}, {'id': 'OG001', 'title': 'Lina 2.5mg Plus Met 500mg', 'description': 'Single tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '7079.65', 'spread': '1688.14', 'groupId': 'OG000'}, {'value': '6808.27', 'spread': '1708.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (percent)', 'ciPctValue': '90', 'paramValue': '105', 'ciLowerLimit': '101', 'ciUpperLimit': '108', 'estimateComment': 'Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.', 'groupDescription': 'The two formulations are shown to be bioequivalent if the 90 percent confidence interval of geometric mean ratio is entirely contained within the 80 to125 percent range both on measured data (statistical analysis 1) and potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR, potency corrected (percent)', 'ciPctValue': '90', 'paramValue': '108', 'ciLowerLimit': '105', 'ciUpperLimit': '112', 'estimateComment': 'Lina/Met 2.5mg/500mg vs.Lina 2.5mg plus Met 500mg.', 'groupDescription': 'ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period', 'description': 'AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve 0 to Inf (AUC0-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lina/Met 2.5mg/500mg', 'description': 'Combination tablet'}, {'id': 'OG001', 'title': 'Lina 2.5mg Plus Met 500mg', 'description': 'Single tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '7198.79', 'spread': '1689.89', 'groupId': 'OG000'}, {'value': '6923.79', 'spread': '1714.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (percent)', 'ciPctValue': '90', 'paramValue': '105', 'ciLowerLimit': '101', 'ciUpperLimit': '108', 'estimateComment': 'Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.', 'groupDescription': 'ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence (BE), AUC0-inf was no BE criteria'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR, potency corrected (percent)', 'ciPctValue': '90', 'paramValue': '108', 'ciLowerLimit': '105', 'ciUpperLimit': '112', 'estimateComment': 'Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.', 'groupDescription': 'ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'BE, AUC0-inf was no BE criteria'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period', 'description': 'AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg', 'description': 'Combination tablet Linagliptin (Lina) /Metformin (Met) 2.5mg/500mg followed by single tablets Linagliptin 2.5mg plus Metformin 500mg'}, {'id': 'FG001', 'title': 'Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg', 'description': 'Single tablets Linagliptin 2.5mg plus Metformin 500mg followed by combination tablet Linagliptin/Metformin 2.5mg/500mg'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Entered and treated.', 'groupId': 'FG000', 'numSubjects': '29'}, {'comment': 'Entered and treated.', 'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed period 1.', 'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'Completed period 1.', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Out of Range Mid-study-Test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Personal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Washout Period (at Least 35 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Entered and treated.', 'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'Entered and treated.', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed period 2.', 'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'Completed period 2.', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '18 subjects were enrolled in the original study (June 2011 to July 2011) and 40 in the add-on study (November 2011 to December 2011) which was an option provided by protocol to increase the subject number. As no significant STUDY and STUDY-by-TREATMENT effect was revealed in analysis of pooled data, final analysis was performed on pooled data.', 'preAssignmentDetails': 'This is a 2 period, 2 sequence, 2 treatment crossover. Subjects were randomized to one of the two sequences AB or BA. The duration of washout was at least 35 days between dosing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Total number of subjects randomised and treated in the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Dosed participants from combined studies'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2011-06-27', 'resultsFirstSubmitDate': '2012-12-18', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-18', 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period', 'description': 'Maximum measured concentration of metformin in plasma, per period.'}, {'measure': 'Area Under the Curve 0 to Last Measurable Value (AUC0-t)', 'timeFrame': 'Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period', 'description': 'AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve 0 to Inf (AUC0-inf)', 'timeFrame': 'Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period', 'description': 'AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1\\. Healthy male and female subjects.\n\nExclusion criteria:\n\n1\\. Any relevant deviation from healthy conditions.'}, 'identificationModule': {'nctId': 'NCT01383356', 'briefTitle': 'Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Single Dose Comparative Bioavailability Study of Linagliptin/Metformin hydrochloride2.5mg/500mg Combination Tablets Versus Linagliptin 2.5mg Tablets Administered With Glucophage 500mg Tablets Under Fasting Conditions', 'orgStudyIdInfo': {'id': '1288.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linagliptin/Metformin medium dosecombo', 'description': 'patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily', 'interventionNames': ['Drug: Linagliptin/Metformin Combo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Linagliptin plus Metformin medium dose', 'description': 'patient to receive two individual tablets: Linagliptin and Metformin (medium dose)', 'interventionNames': ['Drug: Metformin Single Tablet', 'Drug: Linagliptin Single Tablet']}], 'interventions': [{'name': 'Metformin Single Tablet', 'type': 'DRUG', 'description': 'Metformin medium doseTablet', 'armGroupLabels': ['Linagliptin plus Metformin medium dose']}, {'name': 'Linagliptin/Metformin Combo', 'type': 'DRUG', 'description': 'Fixed dose combination', 'armGroupLabels': ['Linagliptin/Metformin medium dosecombo']}, {'name': 'Linagliptin Single Tablet', 'type': 'DRUG', 'description': 'Linagliptin Single medium dose Tablet', 'armGroupLabels': ['Linagliptin plus Metformin medium dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': '1288.19.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}