Sanofi anounces results of pooled analysis, EDITION III and EDITION IV studies of Toujeo in Types 1 and 2 Diabetes

Sanofi announced that in a pooled analysis, comprised of studies I, II and III from the EDITION program, 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 night-time, were observed with Toujeo during the 8-week titration period when compared with Lantus.

Sanofi also announced results from EDITION III study. In people with Type 2 Diabetes who failed to control their blood sugar levels by treatments other than insulin, EDITION III (n=878) met its primary endpoint by showing similar blood sugar level control (reduction in HbA1C) from baseline between Toujeo and Lantus at 6 months [LS mean change -1.42 (0.05) and -1.46 (0.05) respectively; difference 0.04% (95% CI: -0.09 to 0.17)].

In the EDITION IV study full results showed that people with Type 1 Diabetes, randomized to Toujeo, experienced similar night-time and any-time of the day low blood sugar event rates with Toujeo compared with Lantus. In the initiation phase which was the first 8 weeks of the study night-time low blood sugar event rates were significantly lower with Toujeo compared to Lantus. EDITION IV also demonstrated similar glucose lowering and adverse event results for Toujeo regardless of whether injected in the morning or evening in Type 1 Diabetes patients.