Phase III results for Invokana in T2D-Janssen

Janssen Research & Development has announced new results from a 104-week Phase III clinical study evaluating the long-term effects of Invokana (canagliflozin) in patients aged 55 to 80 years with Type 2 Diabetes inadequately controlled on current antihyperglycemic therapies. The randomized double-blind study showed Invokana provided greater reductions in blood glucose (A1C), and greater reductions in secondary endpoints of fasting plasma glucose, body weight and systolic blood pressure. In the long-term study (DIA3010), after 104 weeks, levels of A1C, the primary endpoint, were significantly reduced with Invokana 100 mg and 300 mg, respectively, relative to placebo: -0.49 percent (95 percent confidence interval [CI] -0.65, -0.32) and -0.60 percent (CI -0.77, -0.44).

A1C, also called hemoglobin A1c, is the percent of red blood cell hemoglobin with glucose attached to it, and is an indicator of average blood glucose over the previous two to three months. The treatment also resulted in significant improvements in a number of secondary endpoints relative to placebo. Treatment was also associated with non-significant changes, relative to placebo, in blood triglycerides and LDL-C (low-density lipoprotein cholesterol). The overall incidence of adverse events (AEs) for Invokana 100 mg, 300 mg and placebo, respectively, was 88 percent, 90 percent, and 86 percent. AE-related discontinuation rates were 5 percent, 10 percent and 7 percent, and serious AE rates were similar across groups. Data were presented at the American Diabetes Association 74th Scientific Sessions.