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news.Akesis Pharmaceuticals has announced positive results of its preliminary analysis from its placebo-controlled Phase IIa trial designed to test the safety and efficacy of AKP-020, a novel vanadium compound, in patients with Type 2 diabetes.
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In this single blinded study seven Type 2 diabetic subjects were dosed with AKP-020 and two with placebo for 28 days. Over the 28-day period, both placebo subjects showed an increase in fasting plasma glucose (FPG) levels.
In contrast, in five out of the seven subjects on active drug treatment, there was a consistent decrease in FPG (range between subjects: 10%-43%); two of the treated subjects showed variable responses (range: +20% to -9%).
The average change of the group was significant compared to the group average baseline (p<0.05). Similarly, the average reduction in the area under the curve (AUC) for the 2h oral glucose tolerance test was over 10% (p<0.05). The levels of glycosylated hemoglobin (HbA1c) are usually measured over three months for definitive demonstration of anti-diabetic activity. Evaluating the trend out to day 28, in the two placebo subjects there was a consistent increase up to 0.5% in absolute terms, or a variable response, respectively. In the treatment arm, in two subjects there was a consistent decrease of 0.5% and 1.1%, in three subjects essentially no change, and in the final two subjects an increase of 0.2% and 0.3%, respectively. After treatment the average HbA1c continued to decline in the treatment group. Akesis plans to determine the statistical significance of these results in future trials.