Eli Lilly, Alkermes start phase 3 study for inhaled insulin

By Lisa Kerner

Erie, Pa., April 26 - Eli Lilly and Co. and Alkermes, Inc. began a phase 3 clinical trial required for registration of their AIR Inhaled Insulin System (AIR system), which is being investigated as a treatment option for type 1 and type 2 diabetes.

The phase 3 open-label, noninferiority study will evaluate the AIR system's effectiveness in improving glucose control compared to injected pre-meal insulin in 400 insulin-naive patients with type 2 diabetes.

Lilly said the efficacy of the AIR system will be assessed for six months, while the safety of the AIR system will be evaluated during an additional six- and 18-month period.

The AIR system delivers insulin via inhalation based on Alkermes' AIR pulmonary drug delivery technology.

Diabetes affects an estimated 194 million adults worldwide and an estimated 20.8 million in the United States.

Lilly is an Indianapolis-based pharmaceutical company.

Alkermes is a Cambridge, Mass., pharmaceutical company that develops products based on drug delivery technologies.

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