Janssen Research & Development, LLC (Janssen) presented results from five Phase 3 clinical studies evaluating canagliflozin in monotherapy and in add-on combination use showing that canagliflozin provided substantial and 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, canagliflozindosed once-daily at 300 mgprovided significantly greater reductions in A1C levels relative to both comparators with similar overall incidence of adverse events. These studies were presented today as late-breaking poster presentations at the 72nd American Diabetes Association (ADA) Annual Scientific Sessions.
Canagliflozin is an investigational sodium glucose co-transporter 2 (SGLT2) inhibitor for the treatment of patients with type 2 diabetes. 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. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.
“Type 2 diabetes is a chronic condition that over time may require the use of combinations of antihyperglycemic agents, including insulin, to maintain optimal glycemic control which is a primary goal of treatment,” said William T. Cefalu, M.D., Chief of the Joint Program on Diabetes, Endocrinology and Metabolism of the Pennington Biomedical Research Center and Louisiana State University Health Sciences Center School of Medicine, and lead investigator on the DIA3009 study. “The sustained glucose control and low rate of occurrence of hypoglycemia shown with canagliflozin, an SGLT2 inhibitor, as compared to glimepiride when evaluated over a 52-week period in this comparative study are very promising. When combined with the other clinical benefits, the data suggests that this class of agents may provide an additional and valuable treatment option for people with type 2 diabetes.”
The global Phase 3 canagliflozin clinical program enrolled more than 10,300 patients in nine studies, and is the largest late-stage development program for an investigational pharmacologic product for the treatment of type 2 diabetes submitted to health authorities to date. The Phase 3 clinical program evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes management, from adult patients treated only with diet and exercise to those requiring insulin injections to maintain glycemic control. According to Johnson & Johnson, the program also included three large studies in special populations: older patients with type 2 diabetes, patients with type 2 diabetes who had moderate renal impairment, and patients with type 2 diabetes who have or were considered to be at high risk for cardiovascular disease. On May 31, 2012, Janssen submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the use of canagliflozin as a treatment for adult patients with type 2 diabetes.
“The results in each of these studies suggest that canagliflozin could provide an effective therapeutic option for adults with type 2 diabetes in a range of clinical settings,” said Kirk Ways, M.D., Ph.D., Vice President and Compound Development Team Leader for canagliflozin at Janssen. “Canagliflozin has the potential to be administered as monotherapy in patients who are inadequately controlled with diet and exercise alone, as an add-on therapy in patients being treated with metformin alone or in combination with sulfonylureas, and in patients with moderate renal impairment. As part of our commitment to develop new therapeutic options for unmet patient needs in the treatment of type 2 diabetes, we look forward to presenting data from the remaining Phase 3 canagliflozin clinical trials in the near future.”