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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:40 - Any
Updated:3/8/2019
Start Date:July 1, 2015
End Date:March 14, 2018

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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

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.


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.
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Adrogue, Buenos Aires
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