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Phase 2b clinical trial data of SGLT2 inhibitor in patients with type 2 diabetes presented at ADA 2010

March 12, 2017

In general, adverse events were mild to moderate and the overall incidence was balanced across all arms of the study. Similar incidences of serious adverse events and discontinuations due to adverse events across treatment arms were observed. A non-dose-dependent increase in vulvovaginal candidal infections was seen in subjects receiving canagliflozin. The incidence of hypoglycemic events was low and similar in the canagliflozin and placebo treatment groups. No safety signals in laboratory studies, electrocardiogram or vital signs were observed.

"We are encouraged by these results and by the initiation of our Phase 3 program, which includes a large, prospective study assessing cardiovascular outcomes," said Martin Fitchet, M.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, J&JPRD. "The size and scope of our canagliflozin late-stage development program also reflects our commitment to build a leading portfolio of pharmaceutical treatments for the care of people with diabetes."

Recruitment for the global Phase 3 canagliflozin clinical program is currently underway, and is expected to enroll more than 10,000 patients with type 2 diabetes. The trials are being conducted to assess the safety and efficacy of canagliflozin dosed at 100 or 300 mg as monotherapy and in combination with oral antihyperglycemic agents and/or insulin. The Phase 3 program also includes CANVAS (CANagliflozin cardioVascular Assessment Study), a prospective Phase 3 study to evaluate the safety and glycemic efficacy in approximately 4,500 patients with type 2 diabetes, who also have either a history of, or high risk of cardiovascular disease. Study overviews are available at clinicaltrials.

SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.