Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.

Key facts

Study ID

NCT02465515

Run by

GlaxoSmithKline

People needed

9463

Starts

2015-07-01

Expected to finish

2018-03-14

Last updated by the study team

2019-03-06

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
• Diagnosis of type 2 diabetes.
• Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
• HbA1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
• Able and willing to provide informed consent.

You may not qualify if…

• Severely reduced kidney function: eGFR <30 ml/min/1.73 m\^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
• Use of a GLP-1 receptor agonist at Screening.
• Severe gastroparesis
• History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
• Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
• Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
• Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
• Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
• Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
• Any other reason the investigator deems the subject to be unsuitable for the study.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Glendale, Arizona, United States
• GSK Investigational Site — Goodyear, Arizona, United States
• GSK Investigational Site — Tempe, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Searcy, Arkansas, United States
• GSK Investigational Site — Chula Vista, California, United States
• GSK Investigational Site — Lancaster, California, United States
• GSK Investigational Site — Lomita, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Moreno Valley, California, United States
• GSK Investigational Site — Northridge, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Marino, California, United States
• GSK Investigational Site — San Ramon, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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