Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT01475734
- Run by
- GlaxoSmithKline
- People needed
- 44
- Starts
- 2011-12-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2017-01-11
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- GSK Investigational Site — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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