Lilly/Alkermes begin PhIII insulin study

USA-based firms Eli Lilly and Alkermes say they have begun a Phase III registration trial for their co-developed AIR inhaled insulin system, in the treatment of type II diabetes. The assessment will compare the average A1C (blood glucose) achieved with the product and injectable pre-meal insulin, over a three-month period.

The companies say that the inhaled system could remove some of the drawbacks associated with regular injection for the estimated 194 million diabetics around the world, 90-95% of whom suffer from the type II form.

The trial, which is designed as an open-label noninferiority study, will enroll approximately 400 insulin-naive patients with type II diabetes who are taking at least one oral antidiabetic medication. Subjects will be randomized to receive insulin via the AIR system or injection for a period of 18 months which will incorporate a full safety and tolerability assessment, the firms note.