Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00935220
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2009-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American 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': 'D000074584', 'term': 'WW Domain-Containing Oxidoreductase'}], 'ancestors': [{'id': 'D000074583', 'term': 'Short Chain Dehydrogenase-Reductases'}, {'id': 'D064430', 'term': 'NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases'}, {'id': 'D000429', 'term': 'Alcohol Oxidoreductases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D025521', 'term': 'Tumor Suppressor Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily', 'otherNumAtRisk': 41, 'otherNumAffected': 5, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13,0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'title': 'Patients with any adverse events (AEs)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Patients with severe AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Patients with drug-related AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'description': 'Frequency of patients with AEs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients'}, {'type': 'SECONDARY', 'title': 'Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'title': 'ECG abnormalities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vital signs abnormalities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physical finding abnormalities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Laboratory finding abnormalities', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'description': '12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients'}, {'type': 'PRIMARY', 'title': 'Linagliptin: AUC_τ,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '194', 'spread': '25.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours', 'description': 'area under the concentration time curve (AUC\\_τ) of linagliptin in plasma at steady state over a uniform dosing interval', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'PRIMARY', 'title': 'Linagliptin: C_max,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '40.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours', 'description': 'maximum concentration of linagliptin in plasma at steady state', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'description': 'Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients'}, {'type': 'SECONDARY', 'title': 'Linagliptin: AUC_0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'spread': '32.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours', 'description': 'area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set- All patients with values for the area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose (AUC\\_0-24) for Linagliptin'}, {'type': 'PRIMARY', 'title': 'DPP-4 Inhibition: E_24,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '84.7', 'groupId': 'OG000', 'lowerLimit': '72.2', 'upperLimit': '91.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One single measurement 24 h after drug administration under steady state conditions', 'description': "Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))\\*100%, where 'activity' is the activity of the DPP-IV enzyme.", 'unitOfMeasure': 'Percent (of inhibition)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Linagliptin: C_max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '57.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24h', 'description': 'maximum concentration of linagliptin in plasma on Day 1', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set - All patients with values for the maximum measured concentration of linagliptin in plasma (C\\_max)'}, {'type': 'SECONDARY', 'title': 'DPP-4 Inhibition: E_24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000', 'lowerLimit': '52.0', 'upperLimit': '89.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One single measurement 24 h after drug administration', 'description': "Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))\\*100%, where 'activity' is the activity of the DPP-IV enzyme.", 'unitOfMeasure': 'Percent (of inhibition)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other reason (not specified)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Linagliptin 5mg', 'description': 'Linagliptin 5mg once daily'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black / African American', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI) continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.93', 'spread': '3.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2009-07-01', 'resultsFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-05', 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linagliptin: AUC_τ,ss', 'timeFrame': '24 hours', 'description': 'area under the concentration time curve (AUC\\_τ) of linagliptin in plasma at steady state over a uniform dosing interval'}, {'measure': 'Linagliptin: C_max,ss', 'timeFrame': '24 hours', 'description': 'maximum concentration of linagliptin in plasma at steady state'}, {'measure': 'DPP-4 Inhibition: E_24,ss', 'timeFrame': 'One single measurement 24 h after drug administration under steady state conditions', 'description': "Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))\\*100%, where 'activity' is the activity of the DPP-IV enzyme."}], 'secondaryOutcomes': [{'measure': 'Treatment Emergent Adverse Events', 'timeFrame': '21 days', 'description': 'Frequency of patients with AEs'}, {'measure': 'Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities', 'timeFrame': '21 days', 'description': '12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities'}, {'measure': 'Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event', 'timeFrame': '21 days', 'description': 'Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event'}, {'measure': 'Linagliptin: AUC_0-24', 'timeFrame': '24 hours', 'description': 'area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose'}, {'measure': 'Linagliptin: C_max', 'timeFrame': '24h', 'description': 'maximum concentration of linagliptin in plasma on Day 1'}, {'measure': 'DPP-4 Inhibition: E_24', 'timeFrame': 'One single measurement 24 h after drug administration', 'description': "Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))\\*100%, where 'activity' is the activity of the DPP-IV enzyme."}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Glycosylated haemoglobin \\>=7 and \\<= 10%\n2. Age \\>=21 and \\<= 65\n3. Body Mass Index \\>=18.5 and \\<=38 kg/m2\n4. African American origin\n5. Signed and dated informed consent prior to admission to the study\n\nExclusion criteria:\n\n1. Any finding of the medical examination considered clinically relevant by the Investigator\n2. Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease including hypertension \\>160-100 mmHg (under current treatment), stroke and transient ischemic attack (TIA).\n3. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes\n4. Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy\n5. Diagnosis of sickle cell anemia or known chronic anemia\n6. History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)\n7. History of relevant allergy/hypersensitivity\n8. Intake of drugs with a long half life (\\>24hours) within at least one month or less than 10 half lives of the respective drug prior to administration except allowed co medication\n9. Alcohol abuse, drug abuse\n10. Any laboratory value of clinical relevance that is outside an acceptable range\n11. Change of drug dosing of allowed co medication\n12. Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.\n13. Fasted glucose \\>270 mg/dl or randomly determined blood glucose \\>400 mg/dl on two consecutive days during screening or wash out\n14. Serum creatinine above upper limit normal at screening'}, 'identificationModule': {'nctId': 'NCT00935220', 'briefTitle': 'Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration in Patients With Type 2 Diabetes Mellitus of African American Origin for 7 Days', 'orgStudyIdInfo': {'id': '1218.55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'linagliptin', 'description': 'Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation', 'interventionNames': ['Drug: linagliptin QD (once daily) for 7 days']}], 'interventions': [{'name': 'linagliptin QD (once daily) for 7 days', 'type': 'DRUG', 'description': 'dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration', 'armGroupLabels': ['linagliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': '1218.55.0006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': '1218.55.0008 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': '1218.55.0004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': '1218.55.0005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': '1218.55.0003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': '1218.55.0001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}