November - 5 - 2009
New data on dapagliflozin were reported at the recent 20th World Diabetes Congress in Montreal.
In a double-blind, multicenter, phase III study in 274 patients with HbA1c of 7.0-10.0%, dapagliflozin 2.5, 5 or 10 mg or placebo was administered each morning for 24 weeks. The mean reductions of HbA1c in these treatment groups were -0.58, -0.77, -0.89 and -0.23%, respectively, while the mean reductions of fasting plasma glucose were -15, -24, -29 and -4 mg/dL, respectively. Dapagliflozin was generally safe and well tolerated, with no treatment-related serious adverse events (Ferrannini, E. et al. 20th World Diabet Congr (Oct 18-22, Montreal) 2009, Abst O-0536).
Data from 3 randomized, double-blind, placebo-controlled studies of dapagliflozin were analyzed to assess the drug's effects in patients who were either treatment-naive, receiving metformin or receiving insulin and insulin sensitizer therapy. Dapagliflozin was effective in patients regardless of disease stage and was associated with continuous weight loss and lowered glycemia without significant hypoglycemia (Bastien, A. et al. 20th World Diabet Congr (Oct 18-22, Montreal) 2009, Abst D-0765).
The occurrence of urinary tract infections (UTI) and genital infections, both known to be increased in type 2 diabetes patients, was evaluated in 2 double-blind, placebo-controlled trials in which patients receiving metformin (N = 546) or insulin plus insulin sensitizer therapy (N = 71) were randomized to dapagliflozin or placebo. UTI rates were similar in dapagliflozin- and placebo-treated patients, but genital infection rates were higher with dapagliflozin. The glycosuria induced by dapagliflozin may play a role in genital infections in type 2 diabetes patients (Bastien, A. et al. 20th World Diabet Congr (Oct 18-22, Montreal) 2009, Abst D-0766).