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

Not Recruiting

Trial ID: NCT02465515


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.

Official Title

A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

Stanford Investigator(s)

Marilyn Tan
Marilyn Tan

Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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.


biological: Albiglutide 30 mg

biological: Albiglutide 50 mg

biological: Albiglutide matching placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305