Posts
Results of a phase 3 study presented at the International Diabetes Federation 2011 World Diabetes Congress in Dubai, United Arab Emirates, demonstrate that when added to sulfonylurea therapy, dapagliflozin reduced HbA1c at 24 weeks vs. placebo plus sulfonylurea in patients with type 2 diabetes. The reduction was maintained at 48 weeks, according to a press release.
Patients assigned to dapagliflozin (Bristol-Myers Squibb; AstraZeneca) plus glimepiride also experienced maintained reductions in fasting plasma glucose, postprandial glucose and total body weight.
Results are from a 24-week extension trial of a 24-week, phase 3, multicenter, randomized, parallel-group, double blind, placebo-controlled study initially presented at the 46th European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden, in September 2010.
Patients with type 2 diabetes and HbA1c levels between 7% and 10% were randomly assigned to either dapagliflozin 2.5 mg (n=154), 5 mg (n=142) or 10 mg (n=151) per day or placebo (n=145) plus glimepiride 4 mg per day. At 24 weeks, the primary endpoint was mean change in HbA1c; the 24-week extension was conducted to assess the safety, efficacy and tolerability of dapagliflozin plus glimepiride during the 48-week period. The extension was completed by 519 patients.
After 48 weeks, mean improvements in HbA1c were -0.37% for the 2.5-mg arm (95% CI, -0.6 to -0.14); -0.53% for the 5-mg arm (95% CI, -0.75 to -0.3) and -0.7% for the 10-mg arm (95% CI, -0.92 to -0.47) compared with placebo. FPG, 2-hour postprandial glucose and body weight were also improved compared with placebo.
The rate of at least one adverse event was as follows: 58.4% for 2.5 mg, 60.7% for 5 mg and 58.9% for 10 mg vs. 55.5% for placebo.
Compared with placebo, hypoglycemic events were more frequent in the dapagliflozin groups (9.7% for 2.5 mg, 10.3% for 5 mg and 11.3% for 10 mg) compared with placebo (6.8%), although no patients discontinued treatment due to hypoglycemia.
According to a press release, events suggestive of genital infections were more common in patients assigned to dapagliflozin vs. placebo. Those events suggestive of urinary tract infections were similar in both groups.
0 comments:
Post a Comment