UNMET NEED

Current Guidelines

Lifestyle modification and metformin, an inexpensive noninsulin therapy, are preferred in the early stages of type 2 diabetes treatment [9]. Over time, additional medications become necessary and combinations of drugs, including metformin plus other oral agents, GLP-1 receptor agonists, or injectable insulin, can be effective. In patients with chronically high blood glucose levels, oral medication alone is unlikely to adequately control blood glucose, and insulin therapy is often recommended. Studies indicate that insulin is the most effective way to treat type 2 diabetes as it has durable effects in all patients, offers the greatest reduction in blood glucose, and reduces the decline of insulin-producing cell function [9].

INSULIN TREATMENT NOW RECOMMENDED EARLIER IN THE TREATMENT REGIME

Traditional treatment guidelines following diagnoses of type 2 diabetes recommended that patients start insulin therapy approximately 10 years after initial diagnosis. However, the latest ADA and European Association for the Study of Diabetes guidelines in 2009 recommend earlier use of insulin by patients who are unable to adequately maintain appropriate blood glucose with noninsulin therapy [10]. In 2013, the American Association of Clinical Endocrinologists recommended that if patients present with blood glucose above a certain concentration and are showing symptoms of diabetes complications, they should be placed on insulin immediately [11].

Patient preference studies have concluded that most diabetes patients strongly prefer inhaled insulin to injections. According to the multiple studies conducted at the Harvard School of Public Health, people with type 2 diabetes were almost three times as likely to choose insulin therapy if inhaled insulin was available than if they could only select injectable insulins [12-14]. The preference for inhaled insulin was also strong among type 1 diabetes patients [15].

Several studies have been conducted showing strong patient preference for Exubera inhaled insulin over insulin injections among patients who had experience with both modes of therapy. The graph in Figure 2.1 summarizes the results of a 2002 study demonstrating satisfaction with Exubera over injectable insulin after 6 months and across 298 type 2 diabetes patients [14].

 
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