Evolution of a Pulmonary Insulin Delivery System ( Exubera) for Patients With Diabetes

Priscilla A. Hollander, MD


March 05, 2007


Regardless of the recognition of optimal glycemic control as a key component for improving clinical outcomes and quality of life in patients with diabetes, a large proportion of patients with diabetes fail to meet the recommended glycemic goals. In one survey conducted by the American Association of Clinical Endocrinologists (AACE), data were collected from more than 157,000 people with type 2 diabetes over a 2-year period (2003-2004), and were measured against the AACE target glycated hemoglobin (HbA1c) goal of ≤ 6.5%.[1] Two thirds of patients (67%) failed to meet that goal.[1] These findings are consistent with those of earlier cross-sectional surveys, such as the Third National Health and Nutrition Survey (NHANES III, conducted 1994-1998) and NHANES 1999-2000, which revealed that 57% to 63% of patients with diabetes failed to achieve the American Diabetes Association (ADA) recommended target HbA1c of < 7%.[2] Clearly, improved strategies are urgently needed for the optimal management of diabetes.

Both patient- and physician-related barriers contribute to the delay in initiation of insulin therapy, which has a negative impact on the achievement and maintenance of optimal glycemic control. The reluctance to start insulin treatment encompasses a wide range of patient misconceptions about injection anxiety, risk for side effects and weight gain, and feelings of being more seriously ill or having failed to control the disease.[3,4,5] Physician-related barriers to treatment also contribute to delayed insulin use; for example, physicians may be concerned about the potential side effects of insulin (ie, weight gain, hypoglycemia) as well as the challenges involved in educating their patients about proper insulin administration techniques.[6,7] Results from a recent cross-sectional study indicated that many healthcare providers delay insulin therapy until absolutely necessary, but that the delay is significantly less likely when insulin is viewed as more efficacious and the provider believes that the patient is more adherent to treatment.[4] Taken together, these findings suggest that elimination of the patient- and physician-related barriers to insulin therapy would have a substantial benefit in terms of improving glycemic control and patient outcomes.

Similarly, patient satisfaction with diabetes treatment may improve glycemic control, which has been associated with better quality of life.[8] Thus, diabetes treatments that eliminate treatment barriers and are well accepted by patients are expected to improve outcomes and quality of life. There is an unmet need for an alternative insulin therapy that provides optimal glycemic control, is well tolerated, and improves patient adherence.


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