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news.AtheroGenics has started enrollment of the first patients in a Phase III clinical trial of its oral anti-diabetic agent with anti-inflammatory and antioxidant properties.
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The double-blind, placebo controlled study will be conducted at sites in the US, South Africa, Eastern Europe and India. The trial is designed to randomly assign approximately 1,200 patients with confirmed type II diabetes mellitus to one of three doses of AGI-1067 (75, 150, and 300mg) or placebo for 25 weeks.
All patients enrolled in the trial will be on one or no anti-diabetic medication. The key objective of the trial is to compare the effects three doses of AGI-1067 versus placebo on glycemic endpoints. AtheroGenics is planning to conduct an interim analysis in mid-2008, and the study is expected to conclude before the end of 2008.