Study examines long-term efficacy of dapagliflozin use in Type 2 diabetes management

NEW YORK — An investigational Type 2 diabetes drug may improve glycemic control among patients that are unable to improve their blood sugar with high doses of insulin alone, according to a new study.

Published in the Annals of Internal Medicine, researchers led by John Wilding of University Hospital Aintree in Liverpool, England, found that when Type 2 diabetes patients added dapagliflozin — a selective inhibitor of sodium-glucose cotransporter 2 — in either 5-mg or 10-mg strengths to their daily medication regimen, the patients saw a reduction in their hemoglobin A1C levels and weight at 24 weeks, compared with those who added placebo. These results were maintained by the 48th week of the study; however, patients in the pooled dapagliflozin groups had a higher rate of hypoglycemic episodes (56.6% versus 51.8%), events suggesting genital infection (9% versus 2.5%) and events suggesting urinary tract infection (9.7% versus 5.1%). A total of 800 patients were analyzed in the study.

The researchers added that the study "was not designed to evaluate long-term safety."

The primary funding sources for the study were drug makers AstraZeneca and Bristol-Myers Squibb, which filed for regulatory approval for dapagliflozin with the Food and Drug Administration. In January, the agency declined to approve the drug.

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