Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

A Single-site, Randomized, Double-blind, Placebo-controlled, Parallel-group, Stepped Glucose Clamp Study to Assess the Effects of Albiglutide on Counter-regulatory Hormone Responses and Recovery From Hypoglycemia in Subjects With Type 2 Diabetes Mellitus.

This is a stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner.

This is a Phase II, single-site, randomized, double-blind, parallel-group, placebo-controlled, stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given 3 days before employing a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner. In particular, this study is being conducted to ensure that albiglutide does not impair counter-regulatory responses during hypoglycemia.

Inclusion Criteria:

• Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before Screening
• HbA1c <10% at Screening for subjects who do not require washout of existing OAD or <9% at Screening for subjects who do require washout from existing OAD
• Body mass index in range 28 kg/m2 to40 kg/m2

Exclusion Criteria:

• History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
• History of significant gastrointestinal surgery,
• History of significant cardiovascular disease
• History of a seizure disorder
• Documented hypertension or hypotension
• Use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.
• Current hepatic disease or abnormal liver function tests
• Positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus infection 1 or 2
• History of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)
• Female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum
• Known allergy to any GLP-1 analog or excipients of albiglutide, Baker's yeast, or insulin
• History of type 1 diabetes,
• Prior exposure to GLP-1 agents, including albiglutide
• Blood donation over 500 mL within 8 weeks before Screening