International study finds that dapagliflozin has metabolic benefits

August 9, 2013

An international study has found that dapagliflozin has sustained metabolic benefits compared with glipizide. Benefits included stable weight loss and low rates of hypoglycemia. Additionally, therapy was well-tolerated by patients.

 

An international study has found that dapagliflozin has sustained metabolic benefits compared with glipizide. Benefits included stable weight loss and low rates of hypoglycemia. Additionally, therapy was well-tolerated by patients.

The results of this study were presented in June at the American Diabetes Association 73rd Scientific Sessions, in Chicago.

Dapagliflozin is a selective SGLT2 inhibitor that reduces hyperglycemia in an insulin-independent manner by increasing urinary glucose excretion. In a randomized, double-blind trial, 406 patients with type 2 diabetes mellitus received ≤10 mg/d of dapagliflozin, and 408 patients received ≤20 mg/d of glipizide as add-on treatment to metformin. Dapagliflozin was not inferior to glipizide treatment with regard to HbA1C change at 52 weeks, produced weight loss, and reduced hypoglycemia.

Four-year data from the study are currently available, which is the longest duration of therapy studied for any SGLT2 inhibitor to date. Of the original patient population, 161 patients receiving dapagliflozin and 141 patients receiving glipizide completed 4 years of the study. In both groups, the effect of therapy on HbA1c attenuated over time; however, dapagliflozin demonstrated more persistent benefits than glipizide up to year 4.

While sustained and stable weight loss was seen in patients taking dapagliflozin, those taking glipizide gained weight: −3.95 kg in dapagliflozin patients compared with +1.12 kg in glipizide patients. The difference between the groups was 5.07 kg.

Additionally, patients taking dapagliflozin experienced reduced mean systolic blood pressure, while those taking glipizide did not experience a similar reduction. The number of patients with hypoglycemia was approximately 10-fold less in the dapagliflozin group (5.4%) compared with the glipizide group (51.5%), and most patients with hypoglycemia first presented during the first year of the study. All three major hypoglycemic occurrences were in the glipizide group. In the dapagliflozin group, there were no instances of discontinuation of the drug due to hypoglycemia.

Overall rates of adverse events and severe adverse events were similar between groups. Discontinuation of treatment due to adverse events was 13.3% in the dapagliflozin group and 11.3% in the glipizide group. Some patients in both groups experienced urinary tract infections: 13.5% of patients taking dapagliflozin and 9.3% of patients taking glipizide. One patient taking dapagliflozin and three patients taking glipizide experienced upper urinary tract infections.

Genital infections occurred in 14.3% of dapagliflozin patients and in 2.9% of glipizide patients. Most urinary tract infections and genital infections first presented during the first year of the study, and most were of mild/moderate intensity and resolved with standard treatment. Both types of infections were more common in women.