Pharmacokinetics/Pharmacodynamics of Albiglutide

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01357889
• Date of registration: 19/05/2011
• Primary sponsor: GlaxoSmithKline
• Public title: Pharmacokinetics/Pharmacodynamics of Albiglutide
• Scientific title: A Multidose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Pharmacokinetics and Pharmacodynamics of Albiglutide
• Date of first enrolment: July 2011
• Target sample size: 240
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01357889
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with a historical diagnosis of type 2 diabetes mellitus who are experiencing
inadequate glycemic control on their current regimen of diet and exercise or on a
stable dose of metformin

- Body mass index =20 kg/m2 and =45 kg/m2

- Fasting C-peptide =0.8 ng/mL (=0.26 nmol/L)

- Thyroid-stimulating hormone level is normal or clinically euthyroid

- Female subjects of childbearing potential (i.e., not surgically sterile and/or not
postmenopausal) must be practicing adequate contraception.

Exclusion Criteria:

- Current ongoing symptomatic biliary disease or history of pancreatitis

- History of significant GI surgery

- Recent clinically significant cardiovascular and/or cerebrovascular disease

- History of human immunodeficiency virus infection

- History of, or current hepatic disease

- History of alcohol or substance abuse

- Female subject is pregnant, lactating, or <6 weeks postpartum

- History of type 1 diabetes

- Receipt of any investigational drug 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 any GLP-1 agents
including albiglutide

- History of, or family history of thyroid disease



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Biological: albiglutide (GSK716155)

Primary Outcome(s)

Area under the plasma concentration versus time curve (AUC) and maximum observed plasma concentration (Cmax) of albiglutide [Time Frame: 0, 24, 48, 96, 216, 312, 480 and 672 hours post-dose]

Secondary Outcome(s)

Anti-albiglutide antibody formation [Time Frame: pre-dose at weeks 5, 9, 13 and 17]

Number of participants with adverse events [Time Frame: 12 weeks]

Trough (pre-dose) plasma concentrations of albiglutide [Time Frame: pre-dose at weeks 5, 9, 13 and 17]

Secondary ID(s)

114856

Source(s) of Monetary Support

Please refer to primary and secondary sponsors