Dapagliflozin Successful in Reducing Blood Sugar in Trial

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An experimental diabetes drug by AstraZeneca and Bristol-Myers Squibb called dapagliflozin was found to reduce blood sugar and help type 2 diabetes patients lose weight when given in combination with metformin. Both companies hope to file for approval of the drug later this year or in early 2011.

The data from the Phase III trial was released at the European Association for the Study of Diabetes (EASD) conference in Stockholm, Sweden. The study included 814 adult patients with type 2 diabetes who took dapagliflozin plus metformin for 52 weeks or a combination of glipizide, an older diabetes medication, plus metformin.

Patients taking dapagliflozin/metformin achieved the same reduction in HbA1C, a key indicator of glucose control over 3 months, as glipizide/metformin patients, but with fewer episodes of hypoglycemia (low blood sugar). Those on the experimental drug also lost an average of 3.22 kilos in body weight (about 7 pounds) compared to a weight gain in the control group of participants.

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Overall, the frequencies of adverse events were comparable across both treatment groups, although the risk of urinary tract or genital infections was more common among those taking dapagliflozin.

Dapagliflozin is a once-daily pill that is a member of a class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. These drugs block the reabsorption of glucose in the kidneys and promote its excretion in the urine. Johnson and Johnson are also developing a drug in this class, presently in Phase II trials, which they call canagliflozin.

About 171 million people worldwide suffer from diabetes, and the number is expected to double by 2030. In the United States, about 23.7 million American live with the disease which is worsened by obesity, poor diet and lack of exercise.

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