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news.Alkermes and Eli Lilly have begun a mid-stage clinical trial for their inhaled insulin system, which is being investigated as an alternative to intravenous insulin injection for patients with diabetes.
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The goal of the study is to more fully define the safety and efficacy of the Lilly/Alkermes inhaled insulin system in patients with diabetes. The phase III programme will include pivotal efficacy studies and additional long-term safety studies in both type 1 and type 2 patients.
“We and Lilly are highly encouraged by the clinical data compiled from our inhaled insulin studies conducted to date and are committed to conducting the additional studies needed to further establish the safety and efficacy of inhaled insulin.” said Richard Pops, CEO of Alkermes.
The study seeks to evaluate the developmental inhaled insulin system, compared to injected pre-meal insulin in 400 patients with type 1 diabetes. Patients will be treated for 24 months with a two-month follow-up period. The 70-site study began July 18, in the US and will enrol patients in the US, Canada, Belgium, Croatia, Hungary and India.
A second multi-center, global safety study is set to begin in August.