Clinical trial NCT00838903: Efficacy and Safety of Albiglutide in Treatment of 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 When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo 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: 1049
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 if albiglutide is safe and effective in the treatment of 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
* current symptomatic heart failure (NYHA Class III or IV)

Primary outcomes:
measure: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104
timeFrame: Baseline and Week 104
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 156
timeFrame: Baseline and Week 156
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104
timeFrame: Baseline and Week 104
measure: Change From Baseline in 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 104
timeFrame: Week 104
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: 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 Body Weight at Week 104
timeFrame: Baseline and Week 104
measure: Change From Baseline in Body Weight at Week 156
timeFrame: Baseline and Week 156
Other outcomes:
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country: United States
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state: Alabama
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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: Bountiful
country: United States
facility: GSK Investigational Site
state: Utah
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: 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: 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: 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: Lewisburg
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Alabaster
country: Albania
facility: GSK Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
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: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Berlin
country: Germany
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: Tijuana
country: Mexico
facility: GSK Investigational Site
state: Baja California Norte
city: Torreon
country: Mexico
facility: GSK Investigational Site
state: Coahuila
city: Pachuca
country: Mexico
facility: GSK Investigational Site
state: Hidalgo
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Morelia
country: Mexico
facility: GSK Investigational Site
state: Michoacán
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Distrito Federal
country: Mexico
facility: GSK Investigational Site
city: Durango
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: 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: Piura
country: Peru
facility: GSK Investigational Site
city: Cebu 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: Arkhangelsk
country: Russian Federation
facility: GSK Investigational Site
city: Irkutsk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Boksburg North
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Lenasia
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Parktown
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Kempton Park
country: South Africa
facility: GSK Investigational Site
city: Parow
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Soweto
country: South Africa
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Plymouth
country: United Kingdom
facility: GSK Investigational Site
state: Devon
city: Canterbury
country: United Kingdom
facility: GSK Investigational Site
state: Kent
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Sunbury-on-Thames
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Port Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Renfrewshire
city: Coventry
country: United Kingdom
facility: GSK Investigational Site
state: West Midlands
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
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.