Clinical trial NCT00839527: A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
Official title: A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2 inclusive

Exclusion Criteria:

* females who are pregnant, lactating, or less than 6 weeks post-partum
* current symptomatic heart failure (NYHA Class II-IV)

Primary outcomes:
measure: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 104 and Week 156
timeFrame: Baseline, Week 104, and Week 156
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in FPG at Week 104 and Week 156
timeFrame: Baseline, Week 104, and Week 156
measure: Time to Hyperglycemia Rescue
timeFrame: From the start of study medication until the end of the treatment (up to Week 156)
measure: Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52
timeFrame: Week 52
measure: Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156
timeFrame: Week 156
measure: Change From Baseline in Body Weight at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Body Weight at Week 104 and Week 156
timeFrame: Baseline, Week 104, and Week 156
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Dothan
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Gilbert
country: United States
facility: GSK Investigational Site
state: Arizona
city: Green Valley
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Bull Shoals
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Harrisburg
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Hot Springs
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state: Arkansas
city: Jonesboro
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state: Arkansas
city: Searcy
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state: Arkansas
city: Buena Park
country: United States
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state: California
city: Chino
country: United States
facility: GSK Investigational Site
state: California
city: Chula Vista
country: United States
facility: GSK Investigational Site
state: California
city: Commerce
country: United States
facility: GSK Investigational Site
state: California
city: Escondido
country: United States
facility: GSK Investigational Site
state: California
city: Foothill Ranch
country: United States
facility: GSK Investigational Site
state: California
city: Fountain Valley
country: United States
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state: California
city: Fresno
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state: California
city: Fullerton
country: United States
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state: California
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country: United States
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country: United States
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country: United States
facility: GSK Investigational Site
state: California
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facility: GSK Investigational Site
state: California
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country: United States
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state: California
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country: United States
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city: San Diego
country: United States
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country: United States
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country: United States
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country: United States
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country: United States
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country: United States
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country: United States
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city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
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country: United States
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state: Georgia
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country: United States
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state: Georgia
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country: United States
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city: Stone Mountain
country: United States
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country: United States
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state: Georgia
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country: United States
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country: United States
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state: Hawaii
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country: United States
facility: GSK Investigational Site
state: Idaho
city: Idaho Falls
country: United States
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state: Idaho
city: Aurora
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Evergreen Park
country: United States
facility: GSK Investigational Site
state: Illinois
city: Gurnee
country: United States
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state: Illinois
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country: United States
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state: Illinois
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country: United States
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country: United States
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facility: GSK Investigational Site
state: Indiana
city: Evansville
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state: Indiana
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state: Indiana
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state: Indiana
city: Lafayette
country: United States
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state: Indiana
city: South Bend
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state: Indiana
city: Council Bluffs
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state: Iowa
city: Des Moines
country: United States
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state: Iowa
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country: United States
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state: Iowa
city: Iowa City
country: United States
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state: Iowa
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state: Iowa
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country: United States
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country: United States
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state: Maryland
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country: United States
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state: Massachusetts
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country: United States
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state: Michigan
city: Benzonia
country: United States
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state: Michigan
city: Bloomfield Hills
country: United States
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state: Michigan
city: Cadillac
country: United States
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state: Michigan
city: Dearborn
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kalamazoo
country: United States
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state: Michigan
city: St Clair Shores
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Gulfport
country: United States
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state: Mississippi
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country: United States
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state: Mississippi
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country: United States
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state: Mississippi
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country: United States
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state: Missouri
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country: United States
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state: Missouri
city: Kansas City
country: United States
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state: Missouri
city: Kansas City
country: United States
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state: Missouri
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country: United States
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state: Missouri
city: St. Louis
country: United States
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state: Missouri
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country: United States
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state: Missouri
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state: Missouri
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state: Montana
city: Butte
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state: Montana
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country: United States
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state: Montana
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country: United States
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state: Nebraska
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state: Nebraska
city: Omaha
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state: Nebraska
city: Omaha
country: United States
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state: Nebraska
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state: Nebraska
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state: Texas
city: Midland
country: United States
facility: GSK Investigational Site
state: Texas
city: North Richland Hills
country: United States
facility: GSK Investigational Site
state: Texas
city: Odessa
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Schertz
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugarland
country: United States
facility: GSK Investigational Site
state: Texas
city: Temple
country: United States
facility: GSK Investigational Site
state: Texas
city: Orem
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: West Valley City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Hampton
country: United States
facility: GSK Investigational Site
state: Virginia
city: Manassas
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Suffolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Virgina Beach
country: United States
facility: GSK Investigational Site
state: Virginia
city: Weber City
country: United States
facility: GSK Investigational Site
state: Virginia
city: Federal Way
country: United States
facility: GSK Investigational Site
state: Washington
city: Renton
country: United States
facility: GSK Investigational Site
state: Washington
city: Richland
country: United States
facility: GSK Investigational Site
state: Washington
city: Selah
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Lewisburg
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Villingen-Schwenningen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kuenzing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kelkheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rotenburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Bad Lauterberg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Chaiwan
country: Hong Kong
facility: GSK Investigational Site
city: Kwun Tong, Kowloon
country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Tai Po,
country: Hong Kong
facility: GSK Investigational Site
city: Aurangabad
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Callao
country: Peru
facility: GSK Investigational Site
state: Lima
city: Ica
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Marikina City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: San Juan
country: Philippines
facility: GSK Investigational Site
city: Taytay Rizal
country: Philippines
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Alzira/Valencia
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Coventry
country: United Kingdom
facility: GSK Investigational Site
state: West Midlands
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.