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news.Eli Lilly and Alkermes have initiated a phase III clinical trial required for registration for their AIR inhaled insulin system, which is being investigated as an innovative treatment option for type 1 and type 2 diabetes.
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The AIR system delivers insulin via inhalation based on Alkermes’ AIR pulmonary drug delivery technology. The system uses a small, simple inhaler that fits in the palm of a hand.
This study in type 2 diabetes patients is designed to compare A1C, an average measure of (glucose) over a three-month period, between the AIR system and injectable pre-meal insulin. The study is part of the comprehensive phase III pivotal program that began in July 2005.
The phase III open-label, noninferiority study is designed to evaluate whether the AIR system is at least as effective in improving glucose control as injected pre-meal insulin. Approximately 400 insulin-naive patients with type 2 diabetes who are taking at least one oral antidiabetic medication will be randomized to one of the two treatment groups.
The efficacy of the AIR system will be assessed for six months, and the safety of the AIR system will continue to be evaluated during an additional six and 18-month period.