Amylin’s Type 2 Diabetes Drug, BYDUREON, Fails to Meet Primary End Point in New Study

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Amylin Pharmaceuticals, Eli Lilly and Alkermes announced the top-line results from the DURATION-6 study comparing once weekly BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, to Novo Nordisk’s daily Victoza (liraglutide (rDNA origin) injection). Both drugs are members of the class of type 2 diabetes medications known as glucagon-like peptide-1 (GLP-1) receptor agonists.

The 26-week open-label multicenter clinical study compared A1C levels of type 2 diabetes patients taking BYDUREON (2 mg weekly) to patients taking Victoza administered at the maximum approved dose of 1.8 mg daily. The 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.

Gastrointestinal adverse events occurred more frequently among Victoza patients (nausea reported among 20 percent of patients, vomiting 11 percent, diarrhea 13 percent) compared with BYDUREON patients (nausea 9 percent, vomiting 4 percent, diarrhea 6 percent). Injection site nodule occurred more frequently among BYDUREON users (10 percent) compared with Victoza users (1 percent). There were no major hypoglycemia events in either treatment group.

The companies said further evaluation of this data set is underway and, when complete, the companies plan to submit the full study results for publication.

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