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news.Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) has released data from Phase 2b dose-ranging trial of Canagliflozin, which showed an improved glycemic control and was also associated with a decrease in body weight, in patients diagnosed with type 2 diabetes who were concurrently treated with metformin.
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Canagliflozin, an investigational, oral, selective sodium-glucose transporter-2 (SGLT2) inhibitor, is a member of a new class of antihyperglycemic therapies under development to treat type 2 diabetes.
Canagliflozin Phase 2b dose-ranging trial data were presented at the 70th American Diabetes Association (ADA) Annual Scientific Sessions.
In the 12-week Phase 2b dose-ranging study, Canagliflozin was administered at once-daily doses of either 50, 100, 200 or 300mg, or 300mg twice a day, to the patients with type 2 diabetes concurrently receiving the oral antidiabetic drug metformin.
Reportedly, patients were randomised to these arms had observed mean A1C reductions from baseline1 of 0.8, 0.8, 0.7, 0.9 and 0.9%, respectively. A group randomised to receive a once-daily 100mg dose of another oral antidiabetic, sitagliptin, in an active reference arm had observed mean A1C reductions of 0.7% from baseline. In subjects randomised to placebo, A1C decreased by 0.2%.
Body weight, a key secondary endpoint, decreased from baseline in patients receiving Canagliflozin by 2.3 to 3.4% compared to a 1.1% weight loss in subjects in the placebo arm. Patients on sitagliptin lost 0.6% of body weight from baseline. The study was not powered to compare efficacy between canagliflozin and sitagliptin.
J&JPRD said that the enrollment of patients for the Phase 3 Canagliflozin clinical program is currently underway, and is expected to recruit more than 10,000 patients with type 2 diabetes. The trial is expected to assess the safety and efficacy of Canagliflozin dosed at 100 or 300mg as monotherapy and in combination with oral antihyperglycemic agents and/or insulin.
J&JPRD added that the Phase 3 program also includes CANVAS (CANagliflozin cardioVascular Assessment Study), a Phase 3 study to evaluate the safety and glycemic efficacy in approximately 4,500 patients with type 2 diabetes, who also have either a history of, or high risk of cardiovascular disease.
Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center at Medical City, clinical professor of medicine at the University of Texas Southwestern Medical School and lead investigator of the study, said: “Most people with type 2 diabetes require treatment with combinations of drugs from multiple classes to attain and sustain good glycemic control.
“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 data need to be confirmed in long-term trials, and I am looking forward to reviewing the results from those ongoing studies.”
Martin Fitchet, global therapeutic area head of cardiovascular and metabolism at J&JPRD, said: “We are encouraged by these results and by the initiation of our Phase 3 program, which includes a study assessing cardiovascular outcomes.”