A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Key facts

Study ID

NCT01098539

Run by

GlaxoSmithKline

People needed

507

Starts

2010-05-01

Expected to finish

2012-11-01

Last updated by the study team

2017-02-28

Who can join

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

You may qualify if…

• Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
• BMI >/=20 kg/m2 and </=45 kg/m2
• Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
• HbA1c between 7.0% and 10.0%, inclusive.

You may not qualify if…

• History of cancer
• History of treated diabetic gastroparesis
• Current biliary disease or history of pancreatitis
• History of significant gastrointestinal surgery
• Recent clinically significant cardiovascular and/or cerebrovascular disease
• History of human immunodeficiency virus infection
• Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
• Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
• Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
• Receipt of any investigational drug or sitagliptin 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

Where it is running

• GSK Investigational Site — Gulf Shores, Alabama, United States
• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Toney, Alabama, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Gatos, California, United States
• GSK Investigational Site — Orange, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Dimas, California, United States
• GSK Investigational Site — Tarzana, California, United States
• GSK Investigational Site — West Hills, California, United States
• GSK Investigational Site — Whittier, California, United States
• GSK Investigational Site — Whittier, California, United States
• GSK Investigational Site — Doral, Florida, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami Beach, Florida, United States
• GSK Investigational Site — New Port Richey, Florida, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.