LILLY, ALKERMES INITIATE PHASE III STUDY FOR INHALED INSULIN
Eli Lilly and Alkermes initiated a Phase III clinical trial required for registration for their inhaled insulin system, which is being investigated as an innovative treatment option for diabetes. The study will explore the safety and efficacy of the Lilly/Alkermes inhaled insulin system in patients with diabetes.
This Phase III open-label, randomized study is designed to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in 400 non-smoking patients with Type 1 diabetes. Patients will be treated for 24 months with a two-month follow-up period. A second multicenter, global safety study to support registration will begin in August. The study is designed to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in 600 Type 1 and Type 2 diabetes patients with mild-to-moderate asthma or mild-to-moderate chronic obstructive lung disease. Patients will be treated for 12 months with a two-month follow-up period.
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