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This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albiglutide | Active Comparator | albiglutide injection |
|
| albiglutide placebo | Placebo Comparator | placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK716155 subcutaneous injections | Drug | albiglutide subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| blood plasma levels of GSK716155 | on days 2 & 9 |
| Measure | Description | Time Frame |
|---|---|---|
| blood plasma levels of GSK716155 | on days 2 & 9 |
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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 | Miramar | Florida | 33025 | 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 |
|---|---|
| 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 |
| ID | Type | URL | Comment |
|---|---|---|---|
| GLP106073 | Clinical Study Report | 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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| placebo injection |
| Biological |
placebo injection |
|
|
| Orlando |
| Florida |
| 32809 |
| United States |
| GSK Investigational Site | Honolulu | Hawaii | 96814-4224 | United States |
| GSK Investigational Site | Portland | Oregon | 97239 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| GLP106073 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP106073 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP106073 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP106073 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP106073 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GLP106073 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D004700 | Endocrine System Diseases |