Eli Lilly, Alkermes complete enrollment for phase 3 safety study for inhaled insulin

New York, June 5 - Eli Lilly and Co. and Alkermes, Inc. announced that they completed enrollment of patients for the pivotal safety study required for registration for their Air Inhaled Insulin System, which is being investigated as an innovative treatment option for diabetes.

The goal of the research is to more fully define the safety and efficacy of the AIR insulin system in patients with type 1 diabetes.

Phase 3 studies began in July 2005 and also include pivotal efficacy studies and additional long-term safety studies in both type 1 and type 2 diabetes patients.

In the trial which just completed enrollment, the AIR system is being compared to injected pre-meal insulin in nearly 400 non-smoking patients with type 1 diabetes. Patients are being treated for 24 months with a two-month follow-up period. Pulmonary safety tests are used to assess safety. The trial will also evaluate the noninferiority of AIR insulin to injected insulin lispro with respect to A1C levels, the average measure of blood glucose over a three month period.

Patients have been enrolled at 66 locations in the United States, Canada, Belgium, Croatia, Hungary and India.

Eli Lilly is an Indianapolis pharmaceutical company, while Alkermes is a Cambridge, Mass., pharmaceutical company.

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