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www.fdanews.com/articles/73342-data-support-exubera-efficacy-safety-profile-in-type-1-and-type-2-diabetes

Data Support Exubera Efficacy, Safety Profile in Type 1 and Type 2 Diabetes

June 14, 2005

Results from three two-year studies show that Exubera, an inhalable, short-acting, dry powder insulin, provided effective, sustained glycemic control and was well-tolerated over two years in adults with Type 2 diabetes.

A fourth study showed that three months of Exubera therapy was well-tolerated and as effective as subcutaneous (injectable) short-acting insulin in achieving tight glycemic control in adults with Type 1 diabetes.

A pooled analysis of two Phase III studies involving 304 adults with Type 2 diabetes showed that people who added Exubera to their treatment regimen maintained glycemic control for the two-year period and experienced no clinically important effects on pulmonary function compared to patients treated with oral agents alone. An additional analysis from a third study of 384 adults treated with Exubera during a two-year, open-label extension further supported these findings.

A separate study involving 226 adults with Type 1 diabetes showed that Exubera was well-tolerated and as effective as subcutaneous, short-acting insulin in achieving tight glycemic control. Those who received Exubera for three months demonstrated improved glycemic control from baseline and experienced no clinically important effects on pulmonary function compared to adults treated with subcutaneous insulin alone.

The most common adverse events reported in the trials were hypoglycemia and cough.