Amylin Pharmaceuticals, Inc. AMLN, Eli Lilly and Company LLY and Alkermes, Inc. ALKS today announced top-line results from DURATION-6, a head-to-head study designed to compare weekly BYDUREON, an investigational type 2 diabetes therapy, to daily Victoza.
Both drugs are members of the class of type 2 diabetes medications known as glucagon-like peptide-1 (GLP-1) receptor agonists.
This open-label 26-week, multicenter clinical study compared BYDUREON (2 mg weekly) to Victoza administered at the maximum approved dose of 1.8 mg daily. The study was designed to measure A1C, an assessment of average blood sugar, and to evaluate safety and tolerability.
Results showed that patients receiving BYDUREON experienced a reduction in A1C of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza. BYDUREON did not meet the pre-specified primary endpoint of non-inferiority to Victoza.
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