Clinical trial NCT01128894: A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
Official title: A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: GSK716155
liraglutide
albiglutide
open-label
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 841
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: This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Detailed description: This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
* BMI \>/=20kg/m2 and \</=45 kg/m2
* Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L)
* HbA1c between 7.0% and 10.0%, inclusive
* Female subjects of childbearing potential must be practicing adequate contraception.

Exclusion Criteria:

* History of cancer
* History of treated diabetic gastroparesis
* Current biliary disease or history of pancreatitis
* History of significant GI surgery
* Recent clinically significant cardiovascular and/or cerebrovascular disease
* Hypertension
* History of human immunodeficiency virus infection
* History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
* History of alcohol or substance abuse
* Female subject is pregnant, lactating, or \<6 weeks postpartum
* Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
* History of type 1 diabetes mellitus
* Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
* Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
* History or family history of thyroid disease

Primary outcomes:
measure: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32
timeFrame: Baseline and Week 32
Secondary outcomes:
measure: Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26
timeFrame: Baseline, Weeks 4, 6, 12, 18 and 26
measure: Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32
timeFrame: Baseline and Week 32
measure: Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26
measure: Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32
timeFrame: Week 32
measure: Time to Hyperglycemia Rescue at Week 32
timeFrame: Week 32
measure: Mean Change From Baseline in Body Weight at Week 32
timeFrame: Baseline and Week 32
Other outcomes:
Locations:
city: Birmingham
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: Phoenix
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state: Arizona
city: Tucson
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state: Arizona
city: Searcy
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state: Arkansas
city: Chula Vista
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state: California
city: Escondido
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city: Blue Ridge
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city: Shreveport
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city: Bloomfield Hills
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city: Dearborn
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city: Detroit
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city: Kalamazoo
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city: St Clair Shores
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state: Missouri
city: St. Louis
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city: Lincoln
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state: Nebraska
city: Omaha
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city: Las Vegas
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city: Haddon Heights
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city: Herston
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city: Box Hill
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country: Australia
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country: Australia
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country: Australia
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country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
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city: Nahariya
country: Israel
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city: Goyang
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam-si,
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Callao
country: Peru
facility: GSK Investigational Site
state: Lima
city: Huacho
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: 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: Iloilo City
country: Philippines
facility: GSK Investigational Site
city: Makati City
country: Philippines
facility: GSK Investigational Site
city: Marikina City
country: Philippines
facility: GSK Investigational Site
city: Pasay
country: Philippines
facility: GSK Investigational Site
city: Pasig City
country: Philippines
facility: GSK Investigational Site
city: Pasig
country: Philippines
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: Majadahonda (Madrid)
country: Spain
facility: GSK Investigational Site
city: Modulo H
country: Spain
facility: GSK Investigational Site
city: Sabadell
country: Spain
facility: GSK Investigational Site
city: Torrevieja (Alicante)
country: Spain
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Hertfordshire
country: United Kingdom
facility: GSK Investigational Site
city: Livingston
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Swansea
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pratley RE, Nauck MA, Barnett AH, Feinglos MN, Ovalle F, Harman-Boehm I, Ye J, Scott R, Johnson S, Stewart M, Rosenstock J; HARMONY 7 study group. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014 Apr;2(4):289-297. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6.