The phase II study was designed to evaluate whether inhaled insulin delivered through the Lilly/Alkermes system and injected insulin showed similar effectiveness at controlling blood sugar based on dosing regimens commonly used in the every day management of diabetes.
A total of 259 participants were recruited onto the trial which used the standard measure of blood sugar, A1C, to assess the amount of blood sugar in each patient following administration of either injected or inhaled insulin.
Patients using the inhalation method achieved an average level of 7.9 on the A1C blood sugar count compared to 8.0 in the injected insulin group. In addition, 80% of patients in the study expressed a preference for the Lilly/Alkermes inhaled insulin system at mealtime over injected insulin.
Although the research is very positive, the companies are not the first to investigate a product of this nature. Pfizer, Nektar Therapeutics and Sanofi-Aventis are working in collaboration to gain FDA approval for their inhaled insulin product, Exubera. Trials of Exubera also find the product to be similarly effective to injected insulin. FDA approval is anticipated as early as October 2005, whereas Lilly’s product is unlikely to gain marketing approval until at least 2008.
Lilly and Alkermes established an alliance in 2001 to develop an inhaled insulin system that delivers human insulin inhalation powder (known as HIIP), based on Alkermes’ AIR pulmonary drug delivery technology. The Lilly/Alkermes program is focused on developing an innovative treatment option that can address the challenges associated with managing type 1 and type 2 diabetes.