Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: Albiglutide 30 mg
- biological: Albiglutide 50 mg
- biological: Albiglutide matching placebo
Eligibility
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.
Ages Eligible for Study
40 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
SPECTRUM
6507211300
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.