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This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | In Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen. |
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| Group B | Experimental | In Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen. |
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| Group C | Experimental | In Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen. |
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| Group D | Experimental | In Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm. |
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| Group E | Experimental | In Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg. |
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| Group F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK716155 subcutaneous injections | Drug | GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic measurements for different injection sites after one dose. | Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic measurements at three different times after one dose. | Up to Day 29 |
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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 | Long Beach | California | 90806 | 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. |
| Label | URL |
|---|---|
| Results for study GLP107724 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| GLP107724 | Informed Consent Form | 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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In Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen. |
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| Group G | Experimental | In Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm. |
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| Group H | Experimental | In Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg. |
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| Walnut Creek |
| California |
| 94598 |
| United States |
| GSK Investigational Site | Miramar | Florida | 33025 | United States |
| GSK Investigational Site | Orlando | Florida | 32809 | United States |
| GSK Investigational Site | Morrisville | North Carolina | 27560 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| 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 |
| GLP107724 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP107724 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP107724 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP107724 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP107724 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP107724 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D004700 | Endocrine System Diseases |