A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Key facts

Study ID

NCT01128894

Run by

GlaxoSmithKline

People needed

841

Starts

2010-05-01

Expected to finish

2011-09-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
• BMI >/=20kg/m2 and </=45 kg/m2
• Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
• HbA1c between 7.0% and 10.0%, inclusive
• Female subjects of childbearing potential must be practicing adequate contraception.

You may not qualify if…

• History of cancer
• History of treated diabetic gastroparesis
• Current biliary disease or history of pancreatitis
• History of significant GI surgery
• Recent clinically significant cardiovascular and/or cerebrovascular disease
• Hypertension
• History of human immunodeficiency virus infection
• History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
• History of alcohol or substance abuse
• Female subject is pregnant, lactating, or <6 weeks postpartum
• Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
• History of type 1 diabetes mellitus
• Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
• Receipt of any investigational drug or liraglutide 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 albiglutide in previous studies
• History or family history of thyroid disease

Where it is running

• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Gilbert, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Searcy, Arkansas, United States
• GSK Investigational Site — Chula Vista, California, United States
• GSK Investigational Site — Escondido, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Indio, California, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Mission Viejo, California, United States
• GSK Investigational Site — Orange, California, United States
• GSK Investigational Site — Palm Desert, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Satna Monica, California, United States
• GSK Investigational Site — Spring Valley, California, United States
• GSK Investigational Site — Tarzana, California, United States
• GSK Investigational Site — Tustin, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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