Issue 212 Item 4 Inhaled Insulin Formulations Continue to Show Promise After 4 Y

Encouraging findings from two new studies suggest that in the near future (2005) inhaled insulin formulations will supplant or at least supplement injectable insulin therapy. Dr. Jay Skyler, from the University of Miami, and colleagues presented the long-term follow-up results for a phase II study of Exubera, an inhaled insulin formulation being developed by Pfizer. The study involved 204 diabetic patients who had participated in 3-month clinical trials and elected to continue in an extension phase. Of these patients, 89 received at least 4 years of Exubera therapy.

In early studies, there was some limited evidence that the drug might produce a slight deterioration in pulmonary function. Therefore there was interest in assessing Exubera’s long-term safety and efficacy.

"Among patients who participated in the extension phase there was no loss in the drug’s effectiveness in achieving glycemic control," Dr. Skyler said. After treatment with Exubera for 4 years, the mean HbA1c value was 8.23%, not significantly different from the 8.71% seen when it was first started.

Moreover, "there was no change in pulmonary function, which suggests that initial concerns may have been unfounded," Dr. Skyler said. Still, the full answer to this safety question will not come until later this year when the much larger phase III trial is completed, he added.

If Exubera continues to perform well in clinical trials, Dr. Skyler said it is possible that the drug could appear on the market in 2005, although he said a 2006 release was more likely.

In the second study, Dr. Wayman W. Cheatham, from MannKind Biopharmaceuticals in Danbury, Connecticut, and colleagues describe an inhaled insulin formulation called Technosphere/Insulin that could reduce postprandial stress on beta cells by mimicking the first phase insulin response.

The therapy involves the inhalation of tiny particles that are loaded with regular insulin after the start of meals. The reduced postprandial stress achieved with the therapy could lead to improvements in beta cell function and, as a result, better endogenous glucose hemostasis, the authors note.

Both reports were presented last weekend at the 64th annual scientific session of the American Diabetes Association in Orlando, Florida.

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