Sanofi is developing a new formulation of insulin glargine, Toujeo, for diabetes. Sanofi released data from a pooled analysis of Toujeo at the American Diabetes Association Scientific Sessions, 2014. According to the data, significantly fewer low blood sugar events (hypoglycemia) at any time of the day, including night-time events, were observed in patients receiving Toujeo as compared to Lantus. Toujeo is currently under regulatory review in Europe.
The pooled analysis was comprised of studies I, II and III from the EDITION program, a worldwide and extensive series of Phase 3 studies evaluating the efficacy and safety of Toujeo in broader and diverse populations of people with type 2 diabetes. Full EDITION I and II results have been previously reported.
Full results from the EDITION III trial showed that significantly fewer people with type 2 diabetes, new to insulin therapy, experienced low blood sugar events during the night over the study period (post-hoc analysis) when treated with Toujeo compared with Lantus. This effect was numerically more pronounced, although not significant, during the first 8-week titration phase.
Toujeo® is the intended trade name for insulin glargine [rDNA origin] injection, 300 U/mL; formerly abbreviated as "U300". U300 is not currently approved or licensed anywhere in the world.