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news.Following discussions with the FDA, Amylin, Eli Lilly, and Alkermes have initiated a long-term comparator clinical study of a long-acting release formulation of their type 2 diabetes treatment, Byetta injection.
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This study is designed to generate the type of safety and efficacy data that could form the basis of a new drug application (NDA).
The 30-week open-label, non-inferiority study will assess whether the once-weekly long-acting release formulation of the drug is at least as effective in improving glucose control as twice-daily Byetta.
Approximately 300 subjects with type 2 diabetes who are not achieving adequate glucose control using diet and exercise with or without the use of oral antidiabetic agents will be randomized to one of two treatment groups.
Byetta (twice-daily) was approved by the FDA in April 2005 for the treatment of type 2 diabetes as add-on therapy.
Amylin, Lilly, and Alkermes are working together to develop a sustained release, subcutaneous injection version of Byetta for the treatment of type 2 diabetes based on Alkermes’ proprietary Medisorb technology.