Status:
COMPLETED
Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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 di...
Detailed 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-r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01475734
Start Date
December 1 2011
End Date
July 1 2012
Last Update
January 11 2017
Active Locations (1)
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1
GSK Investigational Site
Chula Vista, California, United States, 91911