AstraZeneca, Bristol-Myers Squibb’s dapagliflozin meets endpoints in Phase III study

Results from a late-stage trial demonstrated that AstraZeneca and Bristol-Myers Squibb’s investigational drug dapagliflozin, when added to metformin, significantly reduced HbA1c levels in patients with type 2 diabetes, compared to placebo plus metformin. The 24-week data, presented at the European Association for the Study of Diabetes meeting, also showed that the SGLT2 inhibitor reduced fasting plasma glucose compared to placebo.

The Phase III study enrolled 546 patients aged 18 years to 77 years with type 2 diabetes that was inadequately controlled with metformin. The patients were randomised to receive one of three doses of dapagliflozin or placebo, all in combination with metformin. The companies said that all doses of dapagliflozin met the primary study endpoint, reduction in HbA1c. Additionally, it was noted that individuals receiving the SGLT2 inhibitor had statistically greater mean reductions in body weight compared to those taking placebo.

According to the drugmakers, dapagliflozin is a potential first-in-class compound, and could be filed for approval in late 2010 or early 2011. In response to the news, UBS analysts remarked that the drug's "unprecedented efficacy offering for an oral anti-diabetic agent -- with what we see as a manageable safety profile -- puts it on a trajectory to be a risk-adjusted global blockbuster." The firm increased sales forecasts for the drug to $705 million from $433 million by 2014.

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