Sanofi Reports Positive Phase 3 Results for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL)
- Meta-analysis of three late-stage trials in people with type 2 diabetes shows decreases in risk of low blood sugar events of up to 31% at night-time, compared with Lantus ® -
- All studies in the phase 3 "EDITION" clinical trial program, including a study with type 1 patients, met their primary endpoint -- Toujeo dossier accepted by the EMA - PARIS, June 14, 2014 (GLOBE NEWSWIRE) -- Sanofi (EURONEXT:SAN) (NYSE:SNY) announced today that, in a pooled analysis, investigational therapy Toujeo ® (insulin glargine [rDNA origin] injection, 300 U/mL) consistently showed significantly fewer low blood sugar events (hypoglycemia) at any time of day, including night-time events, compared with Lantus ® (insulin glargine [rDNA origin] injection, 100 U/mL). The pooled analysis comprised data from three differing type 2 patient populations. In this analysis, more pronounced, significant reductions in low blood sugar rates at any time of day, including nighttime, were observed with Toujeo during the 8-week titration period when compared with Lantus. "Toujeo has been recently accepted for review by EMA and this important milestone is another step forward in expanding our insulin portfolio," said Pierre Chancel, Senior VP, Global Diabetes Division, Sanofi. "We continue to be encouraged by the positive Phase 3 results from EDITION, which demonstrated the potential of Toujeo to help meet unmet needs of people living with diabetes." Type 2 Diabetes 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.