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posted: 12/3/2012 6:00 AM

Experimental diabetes drug helps most vulnerable patients

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By Michelle Fay Cortez
Bloomberg News

MINNEAPOLIS -- Johnson & Johnson's experimental diabetes drug helped the most vulnerable patients in two studies, including older people who struggle to get their blood sugar under control and those at high risk of heart disease.

Two company-funded studies presented at the European Association for the Study of Diabetes in Berlin showed that potential side effects of canagliflozin included dangerously low blood pressure and blood-sugar levels. Bristol-Myers Squibb and AstraZeneca failed to win U.S. approval in January of a rival drug, dapagliflozin, because of safety questions.

The number of people with diabetes is surging worldwide as the population ages and grows heavier. The Centers for Disease Control and Prevention estimates one in three Americans may be diabetic by 2050. Drugs to treat the condition generated $39.2 billion in 2011, making it the third-largest market for pharmaceuticals. Still, millions of people fail to get their blood sugar to target levels, leading to new drug development.

"These studies are to test whether this mechanism and this drug will be safe and well-tolerated in these more vulnerable populations," said Kirk Ways, canagliflozin development team leader for New Brunswick, N.J.-based J&J. "It's important for regulators and physicians to see this information," which supports the company's May filing for Food and Drug Administration approval, he said in a telephone interview.

Canagliflozin and similar drugs known as SGLT2 inhibitors block the kidneys from routing sugar taken from the blood back into the body, and instead excrete it in the urine. Existing diabetes drugs decrease sugar production or increase levels of the hormone insulin that convert the sugar to energy.

While the industry has struggled to prove the novel medicines are safe for long-term use and significantly improve health, about a dozen are in development. Eli Lilly and Boehringer Ingelheim's empagliflozin, Roche Holding and Chugai Pharmaceutical's tofogliflozin and Astellas Pharma's ipragliflozin are in the final stages of study.

Adding J&J's canagliflozin to standard treatment for 18 weeks significantly lowered blood sugar in part of a late-stage study of 1,718 patients at high risk for heart disease who had already been taking insulin for an average of 7.1 years. Patients on the drug lost more weight and had lower blood pressure than those given a placebo, while cholesterol levels and hypoglycemia rates rose. Genital and urinary tract infections, low blood pressure and increased urination were also more common.

A second late-stage study found adding canagliflozin to existing therapy for six months helped control blood sugar levels in 714 patients with an average age of 64 who were struggling with the disease. Dangerously low blood sugar was more common in patients getting the drug than those given a placebo, with one person experiencing a severe episode, the study found.

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