Eli Lilly, Alkermes say inhaled insulin studies yield promising results

By E. Janene Geiss

Philadelphia, June 12 - Eli Lilly and Co. and Alkermes, Inc. reported Saturday new study results of the companies' investigational AIR Inhaled Insulin System that demonstrated promising results in patients.

In a phase 1 study of patients with chronic obstructive pulmonary disease (COPD), absorption and action of the inhaled insulin was reduced by a consistent amount, according to a company news release.

AIR insulin was able to deliver similar results on different days in patients with or without COPD and was generally well-tolerated, officials said.

These study findings, along with other findings, were presented at the American Diabetes Association's annual scientific sessions.

The phase 1 study of COPD patients was designed to evaluate the impact compromised lung function has on inhaled insulin dose delivery.

According to the National Heart, Lung, and Blood Institute, more than 12 million people in the United States have been diagnosed with COPD - a progressive condition made up of emphysema and chronic bronchitis, both inflammatory diseases of the lungs. It is speculated that COPD may also be a risk factor, particularly among women, for developing type 2 diabetes, officials said.

In another study, the company evaluated the impact on blood glucose levels after training people to use the product.

The phase 2 study was designed to compare two levels of training intensity, either standard/patient-directed training, or intensive/provider-coached training for the AIR insulin system on overall blood glucose levels.

In this four-week, multi-center, single-blind noninferiority trial, 102 patients with type 2 diabetes were randomized to receive preprandial AIR insulin plus metformin and one of two different levels of training intensity, either standard/patient-directed training or intensive/provider-coached training. Standard training consisted of written directions and a call-in number for assistance, officials said.

Intensive training included standard training in addition to observation and coaching feedback from a clinician as well as inhalation spirometry training.

The impact of the level of training on blood sugar control was evaluated based on measures of two-hour postprandial blood glucose and HbA1c and the impact the level of training has on safety and blood sugar control.

Results demonstrated that the AIR insulin system is easy to use and can be supported by simple, patient-driven training while helping patients manage blood sugar levels, officials said.

Both training methods had similar rates of compliance with training directions and similar safety profiles.

As noted in previous studies, cough was the most commonly reported adverse event and was reported by 8% of all subjects in the study, officials said.

AIR insulin exposure also was similar between groups and there were no discontinuations due to difficulty of use or dislike of the system.

Lilly and Alkermes are conducting phase 3 clinical trials for AIR, an inhaled insulin system that delivers insulin via inhalation based on Alkermes' AIR pulmonary drug delivery technology.

The Lilly/Alkermes program is focused on developing a treatment option that can help address the challenges associated with managing type 1 and type 2 diabetes.

Alkermes is a Cambridge, Mass., pharmaceutical company.

Eli Lilly is a Indianapolis pharmaceutical products company.

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