Canagliflozin Lowers Blood Sugar in Phase III Diabetes Trials
Studies show sustained reductions in A1C levels (Oct. 2)
Janssen Research & Development, LLC announced on October 2 that the investigational drug canagliflozin substantially lowered blood glucose levels when used as add-on therapy in patients receiving insulin treatment for type 2 diabetes and who are considered to be at increased risk for cardiovascular disease (CVD). The results were presented at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, Germany.
CANVAS (CANagliflozin cardioVascular Assessment Study), also known as DIA3008, is 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 to be at increased risk for CVD. CVD is the leading cause of death in people with type 2 diabetes and accounts for more than 50% of fatalities due to the disease.
The data presented at EASD were from an 18-week substudy of 1,718 patients enrolled in CANVAS who had received insulin for an average period of 7.1 years. Patients in this substudy who were randomized to treatment with daily canagliflozin 100 mg or 300 mg, in addition to their usual insulin regimen, had statistically greater A1C reductions at 18 weeks compared with patients given placebo (percent change from baseline: –0.65% and –0.73%, respectively; P < 0.001).
In another phase III study, also presented at EASD, canagliflozin significantly reduced A1C levels compared with placebo when added to ongoing antihyperglycemic therapy in older patients with type 2 diabetes who did not have 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 (100 mg or 300 mg) or placebo. Patients treated with canagliflozin 100 mg and 300 mg had substantial and sustained decreases in A1C levels, and a significantly greater reduction compared with placebo, after 26 weeks (–0.57% and –0.70%, respectively; P < 0.001).
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