Dapagliflozin is from a new class of type 2 diabetes medications that work by blocking the ability of the kidneys to hold sugar. This causes the kidneys to release sugar as waste in the urine.
Numerous clinical trials have found dapagliflozin to be effective at lowering blood sugar levels. Despite this beneficial effect, the U.S. Food and Drug Administration recently decided not to approve dapagliflozin until more information is available about its possible long-term side effects. The most significant concern cited by the FDA was a potential increase in the rates of bladder and breast cancer in people taking the drug.
Although the current trial wasn't long enough to look for longer-term outcomes, such as cancer, Wilding said that the slight increase in bladder and breast cancer was likely a chance finding. But, he said, because there is concern, it's important to continue surveillance for these cancers in future trials.
The current study was designed to see how the drug would work in combination with insulin and other type 2 diabetes medications.
The researchers enrolled just over 800 people with type 2 diabetes who were already taking insulin to control their blood sugar levels. In addition, the study volunteers could be taking up to two more blood sugar-lowering medications.
Study participants were randomly assigned to one of four treatment groups. They received either a placebo, or one of three doses of dapagliflozin (2.5, 5 or 10 milligrams) daily.
After 24 weeks of treatment, people in the dapagliflozin group lowered their average hemoglobin A1C level between 0.79 percent to 0.96 percent compared with a 0.39 percent reduction in those on placebo. Hemoglobin A1C is about a three-month average blood sugar level. Peo
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