Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that canagliflozin, an investigational, oral, selective sodium-glucose transporter-2 (SGLT2) inhibitor, improved glycemic control, and was also associated with a decrease in body weight, in a Phase 2b dose-ranging trial in patients diagnosed with type 2 diabetes who were concurrently treated with metformin. The data were presented at the 70th American Diabetes Association (ADA) Scientific Sessions.

Canagliflozin is a member of a new class of antihyperglycemic therapies under development to treat type 2 diabetes. Blood glucose filtered in the kidney is mainly reabsorbed into the blood stream by SGLT2. Inhibiting SGLT2 is believed to reduce blood glucose levels by increasing the amount of glucose excreted in the urine, which may also lead to a loss of calories.

"Most people with type 2 diabetes require treatment with combinations of drugs from multiple classes to attain and sustain good glycemic control," said lead investigator Julio Rosenstock, M.D., Director of the Dallas Diabetes and Endocrine Center at Medical City and also a clinical professor of medicine at the University of Texas Southwestern Medical School. "Our study suggests that inhibiting SGLT2 with canagliflozin in combination with metformin could potentially offer a good alternative for treating patients with type 2 diabetes who are not reaching their goals with metformin alone. These are promising data that need to be confirmed in long-term trials, and I am looking forward to reviewing the results from those ongoing studies."

In this 12-week Phase 2b dose-ranging study of 451 patients with type 2 diabetes concurrently receiving the oral antidiabetic drug metformin, canagliflozin was administered at once-daily doses of either 50, 100, 200 or 300 mg, or 300 mg twice a day. Patients randomized to these arms had observed mean A1C reductions from baseline(1) of 0.8, 0.8, 0.7, 0.9 and 0.9 percent, respectively. A group randomized to receive a once-daily 100 mg dose of another oral antidiabetic, sitagliptin, in an active reference arm had observed mean A1C reductions of 0.7 percent from baseline. In subjects randomized to placebo, A1C decreased by 0.2 percent. Body weight, a key secondary endpoint, decreased from baseline in patients receiving canagliflozin by 2.3 to 3.4 percent compared to a 1.1 percent weight loss in subjects in the placebo arm. Patients on sitagliptin lost 0.6 percent of body weight from baseline. The study was not powered to compare efficacy between canagliflozin and sitagliptin.

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