A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
NCT ID: NCT00839527
Last Updated: 2017-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
685 participants
INTERVENTIONAL
2009-02-28
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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metformin + glimepiride + pioglitazone + albiglutide placebo
Metformin + glimepiride + pioglitazone + matching albiglutide placebo
placebo to match albiglutide
albiglutide matching placebo weekly subcutaneous injection
metformin
metformin
glimepiride
glimepiride
pioglitazone
pioglitazone
metformin + glimepiride + pioglitazone placebo + albiglutide
Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
albiglutide
albiglutide weekly subcutaneous injection
metformin
metformin
glimepiride
glimepiride
placebo to match pioglitazone
pioglitazone matching placebo
met + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
placebo to match albiglutide
albiglutide matching placebo weekly subcutaneous injection
metformin
metformin
glimepiride
glimepiride
placebo to match pioglitazone
pioglitazone matching placebo
Interventions
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placebo to match albiglutide
albiglutide matching placebo weekly subcutaneous injection
albiglutide
albiglutide weekly subcutaneous injection
metformin
metformin
glimepiride
glimepiride
pioglitazone
pioglitazone
placebo to match pioglitazone
pioglitazone matching placebo
Eligibility Criteria
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Inclusion Criteria
* BMI 20-45kg/m2 inclusive
Exclusion Criteria
* current symptomatic heart failure (NYHA Class II-IV)
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Alabaster, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Countries
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References
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Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.
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.
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.
Study Documents
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Document Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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112757
Identifier Type: -
Identifier Source: org_study_id
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