Positive results from Phase III studies of TA 7284 (Janssen Pharmaceuticals) in patients with Type 2 Diabetes

Results from five Phase III clinical studies evaluating TA 7284 (canagliflozin), from Janssen Pharmaceuticals, in monotherapy and in add-on combination use showing that canagliflozin provided sustained glycemic improvements in adult patients with Type 2 Diabetes, and was generally well tolerated. In two of these studies comparing canagliflozin to current standard treatments, sitagliptin and glimepiride, canagliflozin provided significantly greater reductions in A1C levels relative to both comparators with similar overall incidence of adverse events. The global Phase 3 programme enrolled more than 10,300 patients in nine studies to evaluate the safety and efficacy of canagliflozin across a broad spectrum of Type 2 Diabetes management, from adult patients treated only with diet and exercise to those requiring insulin injections to maintain glycemic control. It also included three studies in special populations: older diabetic patients, diabetics who had moderate renal impairment, and diabetics who are considered at high risk for cardiovascular disease. The overall incidence of treatment-emergent adverse events was similar in the canagliflozin (76.7%) and sitagliptin (77.5%) groups. Results were presented at the 72nd American Diabetes Association meeting. On May 31, 2012, Janssen Pharmaceutical submitted a New Drug Application to the FDA seeking approval for the use of canagliflozin as a treatment for adult patients with Type 2 Diabetes.