Amylin, Eli Lilly and Alkermes, announced results from long-term extensions of the DURATION-1 and 3 studies evaluating Bydureon (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes. The studies will be presented at the 71st Scientific Sessions of the American Diabetes Association.
Data from the DURATION-1 study showed that after three years, patients receiving Bydureon experienced a significant reduction in A1c (1.6 percentage points) and weight (5.1 pounds) compared to baseline. Bydureon-treated patients also experienced improvements from baseline in several cardiometabolic risk markers, including systolic blood pressure (-2.1 mmHg), total cholesterol (-9.9 mg/dL), LDL cholesterol (-7.0 mg/dL) and triglycerides (-12 percent).
Separately, results from the DURATION-3 study showed that at 84 weeks, patients treated with Bydureon experienced significantly greater A1c reduction from baseline, sustained weight loss and a lower risk of hypoglycemia than patients treated with Lantus (insulin glargine). A1c reduction was 1.2 percentage points for Bydureon compared with 1.0 percentage points for Lantus. Also, significantly more patients taking Bydureon achieved an A1c of less than or equal to 6.5 percent. Patients on Bydureon lost an average of 4.5 pounds while those on Lantus gained an average of 5.3 pounds, a difference of 9.8 pounds between the treatments.
The studies also showed Bydureon was not associated with clinically relevant QT prolongation in patients with type 2 diabetes. The QT interval represents the amount of time the heart’s electrical system takes to repolarize, or recharge, after each beat. Drugs that substantially prolong the QT interval have been associated with cardiac arrhythmias.