Inhaled insulin using AERx insulin Diabetes Management System (AERx iDMS).

Diabetes is a chronic, debilitating disease that afflicts millions of people worldwide and poor glycemic control in this disease leads to numerous microvascular and macrovascular complications. There is growing evidence that tight glycemic control prevents the development, and delays the progression, of microvascular complications and possibly macrovascular disease in patients with diabetes. All patients with Type 1 diabetes and many patients with Type 2 diabetes require intensive insulin therapy to achieve optimal glucose control. Although subcutaneous insulin therapy is the mainstay of insulin therapy, there are patients who fear needles and often refuse to start insulin therapy despite suboptimal glucose control. In these patients, inhaled insulin represents a non-invasive, painless method to administer intensive insulin treatment. The Novo Nordisk AS AERx iDMS (insulin Diabetes Management System) for inhaled insulin is a novel device that administers an aerosol of liquid insulin into the deep lung with dose adjustments as precise as one subcutaneous unit. Initial pharmacokinetic and pharmacodynamic studies demonstrate that the device delivers liquid insulin in a clear dose-response manner and with a rapid onset of action similar to the fast-acting analog insulins. At present, large, long-term Phase III studies are in progress to document not only the efficacy, but also the safety and feasibility of this device in the treatment of patients with diabetes.