Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
With
Duke Clinical Research Institute
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus