Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Biological: placebo

Biological: albiglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01475734

108372

Details and patient eligibility

About

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.

Full description

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.

Enrollment

44 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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