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Analyses Find Type 2 Diabetes Patients Treated with BYDUREON™ Experienced Reduction in Cardiovascular Risk Factors: Results Presented at EASD 2011
Date:9/12/2011

elease for injectable suspension. It is an investigational medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA, which has been available in the U.S. since June 2005 and is used in more than 70 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON received marketing authorization in the European Union in June 2011 and is currently under review in the U.S., with a Prescription Drug User Fee Action (PDUFA) date of January 28, 2012. It is available in the UK and will launch in other major European countries as soon as possible.

Study and Presentation Details:
DURATION-3
Presentation Number 778
Poster Session 062--Exenatide: twice daily to once weekly
Tuesday, Sept. 13, 2011, 1:30-2:30 p.m. Western European Summer TimeThe initial trial was an open-label study of 467 patients not achieving adequate glucose control using metformin therapy alone or in combination with a sulfonylurea. Subjects were randomized to receive treatment with BYDUREON or titrated doses of Lantus. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, safety endpoints including hypoglycemia, cardiovascular risk biomarkers and patient-reported outcomes.

The comparator-controlled extension study evaluated sustained use of BYDUREON or Lantus and is ongoing. Interim results include data from patients (n=346) who entered the extension study and remained on their initial therapy for a total of 84 weeks. Post-hoc analyses examined changes in systolic blood pressure, diastolic blood pressure, LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol and high-sensitivity C-reactive protein in patients with abnormal baseline values; correlat
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
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