Home
Search
Study Topics
Glossary
|
Study 12 of 4179 for search of: | United States, Tennessee |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00518115 |
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Albiglutide (GSK716155) or exenatide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 318 |
Study Start Date: | April 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | GLP110125 |
Study First Received: | August 17, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00518115 |
Health Authority: | United States: Food and Drug Administration |
GSK716155, pharmacodynamics, pharmacokinetics, GLP-1, |
Type 2 Diabetes, metformin, exenatide |
Metabolic Diseases Exenatide Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Glucagon-Like Peptide 1 |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |