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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 normal renal function | Experimental | Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min) |
|
| Stage 1 moderate/severe renal function | Experimental | Subject with estimated GFR >= 20 mL/min and less than 50 mL/min |
|
| Stage 2 normal renal function | Experimental | Subject with GFR greater than 80 mL/min |
|
| Stage 2 moderate renal impairment | Experimental | Subject with estimated GFR >= 30 mL/min and less than 50 mL/min |
|
| Stage 2 subjects requiring hemodialysis | Experimental | Subjects who require hemodialysis |
|
| Stage 2 severe renal impairment not requiring hemodialysis | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albiglutide | Biological | single dose of subcutaneously injected albiglutide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the PK of albiglutide in subjects with varying degrees of proteinuria | 42 days | |
| To assess the effects of hemodialysis on the overall PK profile of albiglutide | 42 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anniston | Alabama | 36207 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25387217 | Derived | 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. | |
| 24918790 | Derived | 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. |
| Label | URL |
|---|---|
| Results for study 108370 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 108370 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C534611 | rGLP-1 protein |
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Subjects with GFR less than 30 mL/min
|
| Stage 2 mild renal impairment | Experimental | Subjects with GFR >= 50 mL/min and <= 80 mL/min |
|
| 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 |
| 42 days |
| Miami |
| Florida |
| 33169 |
| United States |
| GSK Investigational Site | Orlando | Florida | 32809 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70806 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| GSK Investigational Site | Parktown | Gauteng | 2193 | South Africa |
| GSK Investigational Site | Somerset West | 07129 | South Africa |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 108370 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108370 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108370 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108370 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108370 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108370 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D004700 | Endocrine System Diseases |