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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Biological: Albiglutide 30 mg; Biological: Albiglutide matching placebo; Biological: Albiglutide 50 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02465515

116174

2014-001824-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 9,463 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

9,463 participants in 2 patient groups, including a placebo group

Albiglutide

Experimental group

Description:

Albiglutide once weekly by subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed. Albiglutide will be administered in addition to standard therapy for diabetes and cardiovascular health.

Treatment:

Biological: Albiglutide 50 mg

Biological: Albiglutide 30 mg

Placebo

Placebo Comparator group

Description:

Placebo once weekly by subcutaneous injection. Placebo will be administered in addition to standard therapy for diabetes and cardiovascular health.

Treatment:

Biological: Albiglutide matching placebo