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news.AtheroGenics has announced positive results from its Andes Phase III clinical trial of AGI-1067 for the treatment of Type 2 diabetes. The study demonstrated that doses, 75mg and 150mg of AGI-1067 met the primary efficacy endpoint of the reduction in glycosylated hemoglobin compared to placebo at the end of the study's six month dosing regimen.
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Andes, an international, double-blind trial, showed a dose-dependent, statistically significant drop in glycosylated hemoglobin (A1c) of 0.6% and 0.4% in the 150mg and 75mg arms, respectively, at six months, compared to baseline. The placebo group decreased 0.2% from baseline.
In the trial, a regional variation was observed in the placebo arm. Eastern Europe showed a significant decrease of 0.5% for A1c in the placebo arm versus baseline. The other study regions showed an increase of 0.1% in A1c in the placebo arm versus baseline. Importantly, A1c reductions in both AGI-1067 treatment arms were similar across all of the regions in the study.
The study analysis plan was prospectively designed to detect and analyze the effect of regional differences. AtheroGenics will continue to analyze the trial data, including the impact of regional differences.
Based on a preliminary review of the safety data, AGI-1067 was well-tolerated and was not associated with weight gain or hypoglycemia in either of the treatment groups. There was no difference in discontinuations between the groups receiving active drug and placebo.