Phase 2b study of canagliflozin for the treatment of type 2 diabetes

Johnson & Johnson Pharmaceutical Research & Development announced results from its Phase 2b dose-ranging trial of canagliflozin in patients diagnosed with type 2 diabetes who were concurrently treated with metformin. In this 12-week dose-ranging study of 451 patients, canagliflozin was administered at once-daily doses of 50, 100, 200 or 300 mg, or 300 mg twice a day. Patients randomized to these arms had observed mean A1C reductions from baseline 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.

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.

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