None listed
Conditions
Interventions
Treatment with albiglutide or placebo will be randomly allocated in a 1:1 ratio. The starting dose of albiglutide is 30 mg weekly which may be up-titrated to 50mg weekly if further improvement of glyc
Sponsors
GlaxoSmithKline,
Eligibility
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Men or women at least 40 years old with a diagnosis of type 2 diabetes. 2. Established cardiovascular disease, including at least 1 of the following: a. Coronary artery disease with EITHER of the following: • Documented history of spontaneous myocardial infarction, at least 30 days prior to Screening. • Documented coronary artery disease (CAD) ≥ 50% stenosis in 1 or more major epicardial coronary arteries, determined by invasive angiography, or history of surgical or percutaneous (balloon and/or stent) coronary revascularization procedure (at least 30 days prior to Screening for percutaneous procedures and at least 5 years prior to Screening for coronary artery bypass graft (CABG)). b. Cerebrovascular disease – ANY of the following: • Documented history of ischaemic stroke, at least 90 days prior to study entry. • Carotid arterial disease with 50% stenosis documented by carotid ultrasound, magnetic resonance imaging or angiography, with or without symptoms of neurologic deficit. • Carotid vascular procedure (e.g. stenting or surgical revascularisation), at least 30 days prior to Screening. c. Peripheral arterial disease (PAD) with EITHER of the following: • intermittent claudication and ankle:brachial index < 0.9 in at least one ankle
Exclusion criteria
Exclusion criteria: 1. eGFR calculated using MDRD formula <30mL/min/1.73m2 (based on the most recent documented serum creatinine laboratory assessment measured no more than 6 months prior to randomization. Local laboratory creatinine values taken as part of usual care are permitted) or renal replacement therapy. 2. Use of a GLP-1 receptor agonist at Screening. 3. Severe gastroparesis requiring therapy within 6 months prior to Screening. 4. History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones, excess alcohol use). 5. Personal or family history of medullary carcinoma of the thyroid or subject with MEN-2. Personal history of pancreatic neuroendocrine tumours. In the opinion of the investigator, the subject has a medical history which might affect his / her ability to remain in the study for its entire duration, or which might limit management, such as life expectancy of <5 years (e.g. due to active malignancy). 6. Subject has a medical history which in the opinion of the investigator might limit the individual’s ability to take trial treatments for the duration of the study or to otherwise complete the study.
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Korea South, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactMilagros Mercedes Cardenas
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed