AstraZeneca, Bristol-Myers Squibb's dapagliflozin meets goals of late-stage diabetes study

AstraZeneca and Bristol-Myers Squibb announced Monday that their experimental type 2 diabetes drug dapagliflozin met the main goals of a Phase III trial. Dapagliflozin, which the companies may file for regulatory approval later this year or in early 2011, is a first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor being developed as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes, according to the drugmakers.
The trial enrolled 597 patients with type 2 diabetes that was inadequately controlled with at least half the recommended dose of glimepiride. The patients were randomised to receive one of three doses of dapagliflozin or placebo, all in combination with glimepiride, which is marketed as Amaryl by sanofi-aventis. Results at 24 weeks showed that patients taking the SGLT2 inhibitor and glimepiride had significant reductions from baseline in HbA1c of -0.58 percent, -0.63 percent and -0.82 percent for the three doses, respectively, compared to -0.13 percent in the glimepiride arm.
The companies also reported that those patients who received dapagliflozin and glimepiride achieved greater weight loss, -1.18 kg, -1.56 kg, -2.26 kg for the three doses of dapagliflozin, respectively, compared to -0.72 kg for glimepiride plus placebo at week 24. Additionally, more patients taking the experimental drug achieved an HbA1c level of less than 7 percent compared to placebo.
In regards to adverse events, the drugmakers said that these were mostly similar in the different treatment arms, but the data showed that reports suggestive of genital tract infections were more frequently reported in those treated with dapagliflozin.
Last year, AstraZeneca and Bristol-Myers Squibb reported positive results from another Phase III trial of dapagliflozin, when used in combination with metformin. Johnson & Johnson is also developing a SGLT2 inhibitor, canagliflozin, which is currently in Phase III trials.

Reference Articles
24-week Phase 3 study found investigational drug dapagliflozin improved glycosylated hemoglobin (HbA1c) when added to glimepiride in adults with Type 2 diabetes mellitus - (BMS)
Bristol-Myers says diabetes drug meets study goal - (CNBC)
Astra, BMS diabetes drug hits targets in new trial - (London South East)
Diabetes drug from Astra, Bristol meets main targets in study (free preview) - (The Wall Street Journal)

**Published in "First Word"