Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Albiglutide 30 mg; Albiglutide 50 mg; Albiglutide matching placebo
Intervention description: Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.; Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.; Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.
Intervention MeSH terms: rGLP-1 protein; Glucagon-Like Peptide 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9463.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: cardiovascular events /outcomes; Type 2 diabetes mellitus; albiglutide; glucagon-like peptide-1 receptor agonist

Summary:

      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.
    

Eligibility criteria:

        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.