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

Trial ID or NCT#

NCT02465515

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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.
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Investigator(s)

Marilyn Tan
Marilyn Tan
Endocrinologist
Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism

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Contact

SPECTRUM
6507211300

View on ClinicalTrials.gov