FRIDAY, June 25 (HealthDay News) -- In patients with type 2 diabetes who do not respond adequately to metformin alone, the addition of the drug dapagliflozin -- a selective sodium-glucose cotransporter-2 (SGLT2) inhibitor that acts without affecting insulin-dependent systems -- may be an effective treatment option, according to research published in the June 26 American Diabetes Association meeting Special Issue of The Lancet.
Clifford J. Bailey, Ph.D., of Aston University in Birmingham, U.K., and colleagues randomly assigned 546 type 2 diabetes patients who were receiving at least 1,500 mg of metformin daily and had inadequate glycemic control to receive either one of three daily doses of dapagliflozin (2.5, 5, or 10 mg) or placebo in addition to their pre-study doses of metformin for 24 weeks.
In the 534 patients who were included in the final analysis, the researchers found that mean hemoglobin A1c decreased by 0.67 percent in the 2.5 mg dapagliflozin group, 0.70 percent in the 5 mg group, and 0.84 percent in the 10 mg group, compared to a mean decrease of 0.3 percent in the placebo group. They also found that similar proportions of individuals in the dapagliflozin groups and placebo group developed symptoms of hypoglycemia (2 to 4 percent and 3 percent, respectively), higher proportions of the dapagliflozin groups developed signs and symptoms and other reports suggestive of genital infections (8 to 13 percent versus 5 percent), and that the dapagliflozin groups had a higher mean bodyweight loss per person (2.2 kg in the 2.5 mg group, 3.0 kg in the 5 mg group, and 2.9 kg in the 10 mg group) than the placebo group (0.9 kg).
"In the absence of randomized trials, SGLT2 inhibitors are candidates for add-on therapy to metformin as shown in today's study," state the authors of an accompanying comment. "Because of the role of glucotoxicity in the pathophysiology of type 2 diabetes, and in view of weight loss and low risk of hypoglycemia, SGLT2 inhibitors in the future also might be considered for the treatment of early-stage and late-stage type 2 diabetes."
This study was supported by Bristol-Myers Squibb and AstraZeneca, which are jointly developing dapagliflozin. Several authors disclosed financial relationships with one or both of the companies as well as other pharmaceutical and medical device companies.
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