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New diabetes drug controls blood sugar, promotes weight loss--study

Beside the benefit of weight loss, dapagliflozin also regulated blood pressure and led to a significant cut in daily insulin dose.

The new anti-diabetes drug dapagliflozin not only effectively controls chronically high blood glucose levels but it also has the potential to promote weight loss, finds a new study.

Dapagliflozi, is being developed at Bristol-Myers Squibb Co. and AstraZeneca PLC. The product comes in pill form and belongs to a class named sodium-glucose transporter-2 inhibitors (SGLT2).

It is designed in such a way that it inhibits a type of dangerous protein from being absorbed into the bloodstream and raises the quantity of glucose excreted in the urine from the body.

Lead author of the study, Dr Clifford J. Bailey, professor of clinical science at Aston University in Birmingham, England stated, "It works through an entirely different mechanism than any other diabetes drugs currently available.

"And you can add it on to other treatments and get an additional benefit. Plus as far as we can see, it can be used at any stage in the disease process."

Safety and efficacy of dapagliflozin assessed
In a bid to assess the safety and efficacy of dapagliflozin, the researchers enrolled 546 adults with type2 diabetes whose blood sugar was not adequately controlled, despite taking at least 1,500 mg of metformin daily, a popular diabetes medication.

As a part of the study, the participants were assigned to receive 2.5 mg, 5 mg, or 10 mg of dapagliflozin daily or a placebo.

All the patients continued to take insulin, and some were also on other oral treatments.

The researchers noted that after a period of 24 weeks, the levels of hemoglobin A1C, an indicator of levels of sugar in the blood, had diminished significantly in all three treatment groups as opposed to the placebo group.

Observations by the researchers
The researchers noted that after a period of 24 weeks, the levels of hemoglobin A1C, an indicator of levels of sugar in the blood, had diminished significantly in all three treatment groups as opposed to the placebo group.

It was observed that A1C reduced by 0.75 percent in the 2.5 mg group of dapagliflozin, by 0.82 percent in the 5 mg and by 0.9 percent in the 10 mg group, while the reduction in the placebo group was only 0.3 percent.

Weight loss was also greater among patients receiving dapagliflozin. The average weight loss of 0.98 kg (2.2 pounds) was found in patients using the two lower doses of the drug and a loss of 1.67 kg (3.7 pounds) was observed in the 10 mg group.

In contrast, the placebo group exhibited a very slight gain in weight.

Beside the benefit of weight loss, dapagliflozin also regulated blood pressure. Dapagliflozin also led to a significant cut in daily insulin dose.

Another benefit of the drug is that the oral medication is taken only once a day. In addition, the drug does not lower blood sugar to dangerously low levels.

Side effects of the drug
Side effects have been minimal. Due to the excess sugar being released from the body via urine by dapagliflozin, there was a higher incidence of urinary tract infections.

However, the infections were mild and the number of patients who left the treatment because of this problem was very small, just about 1 percent in each group.

John Wilding, a professor of medicine and the head of the diabetes and endocrinology clinical research unit at University Hospital Aintree in the United Kingdom stated, "The trial data that we have so far is supportive that this drug will have a place in the treatment of diabetes.”

The drug manufacturers are planning to file for authorizations of the product by U.S. Food and Drug Administration and European Medicines Agency later this year.

The study is published in The Lancet.