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AtheroGenics Reports Positive Results of Phase III Diabetes Trial

Posted on: Tuesday, 15 April 2008, 12:00 CDT

AtheroGenics has reported topline results from a planned interim analysis of its ongoing Andes Phase III clinical trial of AGI-1067 for the treatment of Type 2 diabetes.

The interim analysis of 806 patients who completed three months in the study showed dose-related, statistically significant reductions in A1c. The mean changes for patients in the 150mg, 75mg, and placebo arms were 0.5%, 0.3%, and 0.1% respectively, (p < 0.001 for 150mg versus placebo, p=0.001 for 75mg versus placebo).

Based on a preliminary review of the safety data, AGI-1067 was well-tolerated. The interim analysis showed no difference in discontinuations between groups receiving active drug and placebo. An independent data safety and monitoring board reviewed these and other data from the clinical trial and recommended that the trial continue to completion.

Andes is evaluating two dose levels of AGI-1067 given once daily over six months. The primary efficacy endpoint is change in hemoglobin A1c (A1c) from baseline compared to placebo in patients with Type 2 diabetes.

Russell Medford, president and CEO of AtheroGenics, said: "These interim results reinforce our belief that AGI-1067 may have the potential to introduce a new therapeutic approach for the treatment of patients with diabetes. We plan to work with the FDA to gain their concurrence on the design of the next study."

Source: Datamonitor

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