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Interim Analysis of Initial Pulmonary Insulin Phase 3 Trial Released

HAYWARD, Calif., April 30 /PRNewswire-FirstCall/ -- Aradigm Corporation (NASDAQ:ARDM) today announced safety and efficacy results from the 12-month interim analysis of the first Phase 3 trial of the AERx(R) iDMS pulmonary insulin product. The trial met its primary safety endpoints with no change in pulmonary function tests and no adverse effects reported from examinations of chest x-rays. Antibody production, while expected to increase in the AERx group due to the new pulmonary route of administration, was not associated with any adverse clinical outcomes. In addition, the main efficacy endpoint of the trial, HbA1c levels, was statistically the same in the AERx and subcutaneous groups.

Although earlier phase 2 data had indicated good mealtime glucose profiles in type 2 patients, the current interim analysis showed delayed post-meal plasma glucose suppression in type 1 diabetics. In the immediate post-meal period, plasma glucose levels were higher, and during the nighttime, plasma glucose levels were lower in the AERx iDMS group compared to the subcutaneous group. Patients in the subcutaneous group received a newer, faster acting insulin (insulin aspart), while AERx patients received a formulation of regular human insulin. Because of the unexpected nature of these observations, Novo Nordisk has decided to amend the current trial protocol to conclude the study in the next few weeks, with approximately 19 months of maximum patient exposure, instead of the planned 24 months patient exposure.

"It is clear that the post-meal glucose effects seen in this study are not caused by the method of insulin delivery. All analysis shows that the AERx System is performing as expected," said Richard Thompson, Chairman and Chief Executive Officer of Aradigm. "We will be working closely with Novo Nordisk to further understand the ramifications of the mealtime results and decide on the next steps for the product."

Bryan Lawlis, Aradigm President and COO added: "Novo Nordisk has committed to maintaining their current level of support for the AERx iDMS project. While we are disappointed that the efficacy outcome was not optimal for type 1 patients, we believe that the market potential in type 2 patients is likely to remain a significant opportunity, especially considering the recent change in diagnostic criteria that has classified 41 million Americans at risk in addition to the more than 16 million with type 2 diabetes."

Source: Aradigm Corporation

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