Phase 3 Trial Update of Canagliflozin for Type 2 Diabetes

Janssen Research & Development announced results from two Phase 3 clinical studies, showing that use of canagliflozin substantially lowered blood glucose levels when used as add-on therapy for type 2 diabetes.

CANVAS (CANagliflozin cardioVascular Assessment Study), also known as DIA3008, was a prospective, double blind, placebo-controlled trial designed to evaluate the efficacy, tolerability and cardiovascular safety of canagliflozin in 4,330 adult patients with type 2 diabetes considered at elevated risk for cardiovascular disease. Data announced were from an 18-week sub-study of 1,718 patients enrolled in CANVAS who were receiving insulin for an average of 7.1 years. Patients in this sub-study who were randomized to treatment with daily canagliflozin 100mg or 300mg, in addition to their usual insulin regimen, had statistically greater A1C reductions at 18 weeks relative to placebo (percent change from baseline, -0.65 and -0.73%, respectively, P<0.001).

In a second Phase 3 study, canagliflozin significantly reduced A1C levels compared to placebo, when added to ongoing antihyperglycemic therapy in older patients with type 2 diabetes not having adequate glycemic control. In this 26-week randomized, double-blind, placebo-controlled study known as DIA3010, 714 patients with a mean age of 63.6 years were given once-daily doses of canagliflozin (100mg or 300mg), or placebo. Patients treated with canagliflozin 100mg and 300mg doses had substantial and sustained decreases in A1C levels, and a significantly greater reduction relative to placebo after 26 weeks (-0.57 and -0.7%, respectively, P<0.001).

Canagliflozin is an investigational sodium glucose co-transporter 2 (SGLT2) inhibitor. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels.

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