Clinical trial NCT00849017: Safety and Efficacy Study of Albiglutide in Type 2 Diabetes
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: placebo
albiglutide
monotherapy
diabetes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-02-23
Enrollment: 309
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 whether albiglutide is effective in the treament of patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* females who are pregnant, lactating, or \<6 weeks post-partum
* CHF NYHA class III-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 Weeks 104 and 156
timeFrame: Baseline and Weeks 104 and 156
measure: Time to Hyperglycemia Rescue
timeFrame: From the start of study medication until the end of the treatment (up to Week 156)
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156
timeFrame: Baseline and 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 156
timeFrame: Baseline and Week 156
measure: Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC
timeFrame: Baseline and Week 52
measure: Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC
timeFrame: Baseline and Week 52
measure: Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC
timeFrame: Baseline and Week 52
measure: Albiglutide Plasma Concentration at Weeks 8 and 24
timeFrame: Weeks 8 and 24
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: Dothan
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: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Bull Shoals
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Searcy
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Carmichael
country: United States
facility: GSK Investigational Site
state: California
city: Chula Vista
country: United States
facility: GSK Investigational Site
state: California
city: Foothill Ranch
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Indio
country: United States
facility: GSK Investigational Site
state: California
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: Lakewood
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Alamitos
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Mission Viejo
country: United States
facility: GSK Investigational Site
state: California
city: Northridge
country: United States
facility: GSK Investigational Site
state: California
city: Palm Desert
country: United States
facility: GSK Investigational Site
state: California
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
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state: California
city: Santa Ana
country: United States
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city: Satna Monica
country: United States
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state: California
city: Spring Valley
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state: California
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state: California
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state: Delaware
city: Clearwater
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state: Florida
city: Cocoa
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city: Panama City
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city: Atlanta
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city: Atlanta
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city: Blue Ridge
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city: Columbus
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state: Georgia
city: Decatur
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state: Georgia
city: Savannah
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state: Georgia
city: Savannah
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state: Georgia
city: Snellville
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state: Georgia
city: Tucker
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state: Georgia
city: Honolulu
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state: Hawaii
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state: Hawaii
city: Idaho Falls
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state: Idaho
city: Chicago
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state: Illinois
city: Evergreen Park
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state: Illinois
city: La Grange
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state: Illinois
city: Naperville
country: United States
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state: Indiana
city: Evansville
country: United States
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state: Indiana
city: Indianapolis
country: United States
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city: La Porte
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city: South Bend
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city: Council Bluffs
country: United States
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state: Iowa
city: Dubuque
country: United States
facility: GSK Investigational Site
state: Iowa
city: Iowa City
country: United States
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city: Waterloo
country: United States
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city: Arkansas City
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city: Newton
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city: Overland Park
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city: Topeka
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city: Crescent Springs
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state: Kentucky
city: Lexington
country: United States
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city: Madisonville
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state: Kentucky
city: Paducah
country: United States
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state: Kentucky
city: Covington
country: United States
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state: Louisiana
city: Lake Charles
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Baltimore
country: United States
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state: Maryland
city: Oxon Hill
country: United States
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state: Maryland
city: Haverhill
country: United States
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state: Massachusetts
city: Bay City
country: United States
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state: Michigan
city: Benzonia
country: United States
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state: Michigan
city: Dearborn
country: United States
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state: Michigan
city: Interlochen
country: United States
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state: Michigan
city: Kalamazoo
country: United States
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state: Michigan
city: Kalamazoo
country: United States
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state: Michigan
city: St Clair Shores
country: United States
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state: Michigan
city: Picayune
country: United States
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state: Mississippi
city: Rolling Fork
country: United States
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state: Mississippi
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state: Missouri
city: Jefferson City
country: United States
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city: Kansas City
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state: Missouri
city: Springfield
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state: Montana
city: Broken Bow
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state: Nebraska
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city: Omaha
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city: Las Vegas
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state: New York
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state: North Carolina
city: Burlington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Calabash
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state: North Carolina
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state: North Carolina
city: Fayetteville
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state: North Carolina
city: Greensboro
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state: North Carolina
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country: United States
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state: North Carolina
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state: North Carolina
city: Mint Hill
country: United States
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state: North Carolina
city: Morehead City
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Tabor City
country: United States
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state: North Carolina
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country: United States
facility: GSK Investigational Site
state: Ohio
city: Canal Fulton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Kettering
country: United States
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state: Ohio
city: Mason
country: United States
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state: Ohio
city: Maumee
country: United States
facility: GSK Investigational Site
state: Ohio
city: Thornville
country: United States
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state: Ohio
city: Zanesville
country: United States
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state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Ashland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Bensalem
country: United States
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state: Pennsylvania
city: Downington
country: United States
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state: Pennsylvania
city: Harrisburg
country: United States
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state: Pennsylvania
city: Lansdale
country: United States
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state: Pennsylvania
city: Melrose Park
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Tipton
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
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state: Pennsylvania
city: East Providence
country: United States
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state: Rhode Island
city: Columbia
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Greenville
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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state: South Carolina
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country: United States
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country: United States
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state: South Carolina
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city: Clarksville
country: United States
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state: Tennessee
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state: Tennessee
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state: Tennessee
city: Nashville
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state: Tennessee
city: Tullahoma
country: United States
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state: Tennessee
city: Arlington
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state: Texas
city: Cleburne
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state: Texas
city: Dallas
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facility: GSK Investigational Site
state: Texas
city: Dallas
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facility: GSK Investigational Site
state: Texas
city: Dallas
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state: Texas
city: Dallas
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state: Texas
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state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
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country: United States
facility: GSK Investigational Site
state: Texas
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country: United States
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state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
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facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
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state: Texas
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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
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Schertz
country: United States
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state: Texas
city: Sugar Land
country: United States
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state: Texas
city: Sugarland
country: United States
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state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
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state: Utah
city: Salt Lake City
country: United States
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state: Utah
city: West Jordan
country: United States
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state: Utah
city: West Valley City
country: United States
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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: Manassas
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
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: 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: Lewisburg
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Tijuana
country: Mexico
facility: GSK Investigational Site
state: Baja California Norte
city: Pachuca
country: Mexico
facility: GSK Investigational Site
state: Hidalgo
city: Zapopan
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Morelia
country: Mexico
facility: GSK Investigational Site
state: Michoacán
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
city: Distrito Federal
country: Mexico
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Nezahualcoyotl
country: Mexico
facility: GSK Investigational Site
city: Puebla
country: Mexico
facility: GSK Investigational Site
city: Torreón
country: Mexico
facility: GSK Investigational Site
city: Parow
country: South Africa
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: Nauck MA, Stewart MW, Perkins C, Jones-Leone A, Yang F, Perry C, Reinhardt RR, Rendell M. Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetologia. 2016 Feb;59(2):266-74. doi: 10.1007/s00125-015-3795-1. Epub 2015 Nov 17.
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.