Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-01 @ 11:57 PM
Study NCT ID:
NCT00938158
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2009-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C534611', 'term': 'rGLP-1 protein'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2011-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2009-07-09', 'studyFirstSubmitQcDate': '2009-07-09', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to characterize the PK of albiglutide in subjects with type 2 diabetes and varying degrees of renal impairment, including subjects requiring hemodialysis, and in age, gender and BMI-matched subjects.', 'timeFrame': '42 days'}], 'secondaryOutcomes': [{'measure': 'To assess the PK of albiglutide in subjects with varying degrees of proteinuria', 'timeFrame': '42 days'}, {'measure': 'To assess the effects of hemodialysis on the overall PK profile of albiglutide', 'timeFrame': '42 days'}, {'measure': 'To assess the safety and tolerability of a single dose of albiglutide in subjects with varying degrees of renal impairment and in age, gender and BMI-matched subjects with normal renal function', 'timeFrame': '42 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['albiglutide', 'hemodialysis', 'pharmacokinetics', 'renal'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': '108370', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108370', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108370', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108370', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108370', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108370', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108370', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '25387217', 'type': 'DERIVED', 'citation': 'Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.'}, {'pmid': '24918790', 'type': 'DERIVED', 'citation': 'Young MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med. 2014 May;126(3):35-46. doi: 10.3810/pgm.2014.05.2754.'}], 'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/108370?search=study&search_terms=108370#rs', 'label': 'Results for study 108370 can be found on the GSK Clinical Study Register.'}, {'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function, including subjects requiring hemodialysis.', 'detailedDescription': 'This adaptive design, non-randomized, open-label, staggered parallel group study evaluates the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function. During Stage 1, a single dose of albiglutide will be administered to subjects with normal renal function and subjects with moderate-to-severe renal impairment not requiring hemodialysis. In addition to subjects with normal renal function and moderate renal impairment, Stage 2 of the study will also include cohorts of subjects requiring hemodialysis, subjects with severe renal impairment not requiring hemodialysis, and potentially subjects with mild renal impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal renal function or renal impairment\n* stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of \\>200mL/min (cohort 3 only)\n* neither pregnant nor lactating\n* HbA1c 6-10.5% inclusive\n* females of childbearing potential must be practicing adequate contraception.\n\nExclusion Criteria:\n\n* inability to meet the PK objectives of the study\n* history of hypoglycemia unawareness or severe hypoglycemia\n* liver function tests greater than or equal to 2 times the ULN\n* clinically significant cardiovascular and/or cerebrovascular disease\n* positive test results for hepatitis B, hepatitis C, or HIV\n* documented hypertension or hypotension at screening\n* known hepatic or biliary abnormalities\n* current use of sulfonylureas\n* active history of tobacco use within 6 months before screening\n* donation of blood in excess of 500mL within 56 days before albiglutide dosing\n* receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing\n* previous or current receipt of exenatide or any other GLP-1 agonist'}, 'identificationModule': {'nctId': 'NCT00938158', 'briefTitle': 'A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Adaptive Design Study for the Assessment of the Pharmacokinetics of Albiglutide in Subjects With Normal Renal Function and Subjects With Moderate-to-severe Renal Impairment and Hemodialysis.', 'orgStudyIdInfo': {'id': '108370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1 normal renal function', 'description': 'Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min)', 'interventionNames': ['Biological: albiglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 moderate/severe renal function', 'description': 'Subject with estimated GFR \\>= 20 mL/min and less than 50 mL/min', 'interventionNames': ['Biological: albiglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 normal renal function', 'description': 'Subject with GFR greater than 80 mL/min', 'interventionNames': ['Biological: albiglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 moderate renal impairment', 'description': 'Subject with estimated GFR \\>= 30 mL/min and less than 50 mL/min', 'interventionNames': ['Biological: albiglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 subjects requiring hemodialysis', 'description': 'Subjects who require hemodialysis', 'interventionNames': ['Biological: albiglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 severe renal impairment not requiring hemodialysis', 'description': 'Subjects with GFR less than 30 mL/min', 'interventionNames': ['Biological: albiglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 mild renal impairment', 'description': 'Subjects with GFR \\>= 50 mL/min and \\<= 80 mL/min', 'interventionNames': ['Biological: albiglutide']}], 'interventions': [{'name': 'albiglutide', 'type': 'BIOLOGICAL', 'description': 'single dose of subcutaneously injected albiglutide', 'armGroupLabels': ['Stage 1 moderate/severe renal function', 'Stage 1 normal renal function', 'Stage 2 mild renal impairment', 'Stage 2 moderate renal impairment', 'Stage 2 normal renal function', 'Stage 2 severe renal impairment not requiring hemodialysis', 'Stage 2 subjects requiring hemodialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '70806', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '2193', 'city': 'Parktown', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -26.18205, 'lon': 28.02671}}, {'zip': '07129', 'city': 'Somerset West', 'country': 'South Africa', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.08401, 'lon': 18.82113}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}