A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: albiglutide; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01128894

114179

Details and patient eligibility

About

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Full 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.

Enrollment: 841 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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841 participants in 2 patient groups

albiglutide

Experimental group

Description:

weekly albiglutide subcutaneous injection

Treatment:

Biological: albiglutide

liraglutide

Active Comparator group

Description:

liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

Treatment:

Drug: liraglutide