©2022 Stanford Medicine
Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
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.
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
- 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.
- 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
- 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
School of Medicine
300 Pasteur Drive
Stanford, CA 94305