Dapagliflozine effectief voor verbetering HbA1c in Type 2 diabetesNieuws - Sep. 30, 2010
Dapagliflozin monotherapy effective for improving HbA1c in Type 2 diabetes
The sodium-glucose cotransporter (SGLT)2 inhibitor dapagliflozin effectively reduces hyperglycemia in newly diagnosed patients with Type 2 diabetes inadequately controlled on diet and exercise alone, show findings from a phase III trial.
Dapagliflozin has previously been shown to be an effective add-on to metformin therapy for patients with Type 2 diabetes. Writing in the journal Diabetes Care, Ele Ferrannini (University of Pisa School of Medicine, Italy) and colleagues report the results of a double-blind, placebo-controlled trial of dapagliflozin 2.5, 5.0, or 10.0 mg/day for the treatment of newly diagnosed Type 2 diabetes.
Overall, 485 treatment-naïve patients with a glycated hemoglobin (HbA1c) level of 7.0-10.0% were enrolled. Of these, 75 were assigned to placebo, and 65, 64, and 70, to dapagliflozin 2.5, 5.0, or 10.0 mg/day, respectively, taken in the morning (main cohort), and 67, 68, and 70 to the corresponding dapagliflozin doses taken in the evening (exploratory cohort) for 24 weeks.
In the main cohort, reductions from baseline at week 24 were 0.23% in the placebo group versus a significantly greater 0.58%, 0.77%, and 0.89% in the dapagliflozin 2.5, 5.0, and 10.0 mg/day groups, respectively. Reductions in the exploratory cohort who were treated in the evening were similar.
By week 24, 41%, 44%, and 51% of the respective dapagliflozin groups overall versus 32% of the placebo group had reached the global recommended target of an HbA1c below 7%.
Adverse events were generally low in the total cohort, but urinary tract infections and genital infections were reported significantly more often in those treated with dapagliflozin 2.5-10.0 mg/day than placebo, at 4.6-12.5% versus 4.0% and 7.7-12.9% versus 1.3%, respectively. No major episodes of hypoglycemia were observed, however.
"The near absence of hypoglycemia and an insulin-independent mechanism of action make dapagliflozin a unique addition to existing treatment options for Type 2 diabetes," conclude the authors.