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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Glucagon-Like Peptide 1; Liraglutide; rGLP-1 protein

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
• 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