Astra and Bristol-Myers hail diabetes test results

27th Jun 2011 06:40

Drugs giants AstraZeneca and Bristol-Myers Squibb announced over the week-end that an extension to the phase 3 trial of their jointly developed dapagliflozin drug indicated that the drug, when added to metformin, provides a new therapeutic option for treatment of type 2 diabetes in patients who have inadequate glycaemic control with metformin alone.The reductions seen in the study ranged from -0.48% in patients receiving dapagliflozin 2.5 milligrams (mg) plus metformin to -0.78% in patients receiving dapagliflozin 10 mg plus metformin, as compared to +0.02% in patients taking placebo plus metformin. Efficacy was evaluated only as an exploratory endpoint; the extension of the trial was primarily designed to assess safety. Adverse events, serious adverse events and adverse events leading to discontinuation reported in the study were balanced across treatment groups, with events suggestive of genital infections and urinary tract infections more common in the dapagliflozin groups. "This study of dapagliflozin added to metformin over 102 weeks suggests that this drug has greater and sustained improvements in glycaemic control and sustained reductions in body weight compared to placebo," said Cliff Bailey, Professor of Clinical Science and Head of Diabetes Research at Birmingham's Aston University. "This information adds to the body of dapagliflozin knowledge and could help the medical community better understand the SGLT2 inhibitor mechanism," he added. --jh