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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00839527 |
The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo Drug: metformin + glimepiride + pioglitazone + albiglutide placebo Biological: metformin + glimepiride + pioglitazone placebo + albiglutide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone. |
Estimated Enrollment: | 600 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
metformin + glimepiride + pioglitazone + albiglutide placebo: Active Comparator
Metformin + glimepiride + pioglitazone + matching albiglutide placebo
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Drug: metformin + glimepiride + pioglitazone + albiglutide placebo
metformin + open-label glimepiride + pioglitazone + albiglutide matching placebo
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met + glimepiride + pioglitazone placebo + albiglutide placebo: Active Comparator
metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
|
Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide matching placebo
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metformin + glimepiride + pioglitazone placebo + albiglutide: Experimental
Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
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Biological: metformin + glimepiride + pioglitazone placebo + albiglutide
metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112757 |
Study First Received: | February 5, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00839527 History of Changes |
Health Authority: | United States: Food and Drug Administration |
diabetes |
Metabolic Diseases Pioglitazone Immunologic Factors Metformin Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents |
Glimepiride Hypoglycemic Agents Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Pioglitazone Immunologic Factors Metformin Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents |
Immunosuppressive Agents Pharmacologic Actions Glimepiride Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Glucose Metabolism Disorders |