Pharmacokinetics/Pharmacodynamics of Albiglutide

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 2

In brief

The first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.

Key facts

Study ID

NCT01357889

Run by

GlaxoSmithKline

People needed

283

Starts

2011-07-01

Expected to finish

2012-10-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Dothan, Alabama, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Hallandale, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Blue Ridge, Georgia, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Paducah, Kentucky, United States
• GSK Investigational Site — Gulfport, Mississippi, United States
• GSK Investigational Site — Picayune, Mississippi, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Greensboro, North Carolina, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Mason, Ohio, United States
• GSK Investigational Site — Bensalem, Pennsylvania, United States
• GSK Investigational Site — Columbia, South Carolina, United States
• GSK Investigational Site — North Myrtle Beach, South Carolina, United States
• GSK Investigational Site — Simpsonville, South Carolina, United States
• GSK Investigational Site — Clarksville, Tennessee, United States
• GSK Investigational Site — McKenzie, Tennessee, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Irving, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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