The incidence of AEs leading to discontinuation was low and similar across treatment groups (3.5% for canagliflozin total and 5.2% for placebo). Most AEs were assessed by the investigator as mild to moderate in intensity, and the overall incidence of AEs was balanced across treatment arms. Adverse events of genital mycotic infections in men and women, and increased frequency of urination (pollakiuria) were more common with canagliflozin 100 mg and 300 mg compared to placebo in men and women; these specific adverse events were generally mild or moderate in intensity and did not lead to discontinuation. Rates of urinary tract infections and hypoglycemia were low and similar across groups.
These data were included in the New Drug Application (NDA) Janssen submitted to the U.S. Food and Drug Administration and the Marketing Authorization Application (MAA) submitted to the European Medicines Agency seeking approval for the use of canagliflozin for the treatment of type 2 diabetes announced on May 31, 2012 and June 26, 2012, respectively.
"This is an exciting new area of research, and these results further support the efficacy and safety profile of canagliflozin," said Kirk Ways, M.D., Ph.D., Vice President and Compound Development Team Leader for canagliflozin at Janssen. "The data are in line with the Phase 3 results announced earlier this year at the annual meetings of the American Diabetes Association and European Association for the Study of Diabetes which suggest that canagliflozin could help control blood glucose in a wide range of patients with type 2 diabetes, including patients on other antihyperglycemic medications such as pioglitazone and metformin."
These results are included in the abstract, "Efficacy and Safety of Canagliflozin in Subjects with Type 2 Diabetes on Metformin and Pioglitazone" (board #64). An additional abstract, "Efficacy and Safety of Canagliflozin in Subjects with Type 2 Diabetes with Moderate Renal Impairment" (board #75) will also be presented at CODHy 2012.