AstraZeneca and Bristol-Myers Squibb have presented promising late-stage data on their investigational diabetes compound dapagliflozin.
Results from a 24-week 546-patient Phase III clinical study, the first late-stage data to be presented on the compound, were unveiled at the European Association for the Study of Diabetes meeting in Vienna. They demonstrated that dapagliflozin, added to metformin, demonstrated significant reductions in the primary endpoint, namely glycosylated haemoglobin levels (HbA1c) and the secondary target of cutting fasting plasma glucose levels in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin.
The study also showed that patients on dapagliflozin, a novel, selective, sodium glucose co-transporter 2 inhibitor, also had statistically greater mean reductions in body weight compared to individuals taking placebo. AstraZeneca quoted Cliff Bailey, head of diabetes research at Aston University in the UK as saying that “given the continued rising prevalence of type 2 diabetes, development of novel treatments such as SGLT2 inhibitors are needed to help improve glycaemic control”. He added that the preliminary data on weight loss and blood pressure may be important adjuvants” to lowering blood sugar levels.
AstraZeneca signed a deal with B-MS in January 2007 to develop and commercialise dapagliflozin, and another diabetes compound Onglyza (saxagliptin), a dipeptidyl peptidase-4 inhibitor. The latter was approved by the US Food and Drug Administration in August and analysts believe that both the drugs covered by the pact will become blockbusters.
